Introduction

Purpose of the Document

This document explains about the functions in Freyr SPAR V5.0.0 – “”; A web-based application developed by Freyr which facilitates Data Collection and Management of the medicinal products.

Intended Audience

This document is written to guide and assist Business users to create Products, Registration & Submission Data, review and approve using various modules of the Freyr SPAR. This document also illustrates examples to perform specific tasks such as User Management, Creation of records, monitor Audit trail and management of system Settings etc.

Functional Scope

The Scope of the document is to provide a comprehensive guide enabling “Business Administrator” and “System administrator” user to perform various functions in SPAR application. Below are the features of SPAR:

1. Dashboard
   1. Reports
   2. Notification List
   3. Notifications
   4. My Tasks
   5. Tasks List
2. Products
   1. Create / Add Product Data
   2. View, Manage Product Data
   3. Disable/ Audit/ Map to Affiliates (Disabled)/ Clone
   4. Product- Draft /Review/Approve
3. Devices
   1. Create / Add Device Data
   2. View, Manage Device Data
   3. Edit/ Disable/ Audit data/ Map to Affiliates (Disabled)
4. Documents
   1. Add Document
   2. View document data
   3. Edit/ Disable/ Audit Document(s)/ Map to affiliates
5. Submissions

5.1 Products

• 1. Applications
     1. Create/ Add Application
     2. Manage Application
     3. Disable/Audit Application(s)
     4. Application – Draft / Review/ Approve
  2. Sequences
     1. Create/ Add Sequence
     2. View, Manage Sequence
     3. Edit/Disable/Audit Sequence(s)
     4. Sequence – Draft /Review/ Approve
  3. Dossiers
     1. View, Manage Dossier
     2. Dossier – Draft / Review /Approve
  4. Registrations
     1. Create/ Add Registration
     2. Manage Registration
     3. View/ Disable/ Audit Registration(s)
     4. Registration – Draft /Review/Approve
  5. Interactions
     1. Create/ Add Interaction
     2. Manage Interaction
     3. View/ Edit/ Disable/ Audit Interaction(s)
  6. Commitments
     1. Create/ Add Commitment
     2. Manage Commitments
     3. Edit/ Disable/ Audit Commitment(s)/ +Interaction
  7. Obligations
     1. Create/ Add Obligations
     2. Manage Obligations
     3. Edit/ Disable/ Audit Obligation(s)/ +Interaction
  8. Global Updates
     1. Create/ Add Global Update
     2. Manage Global Update
     3. View/ Disable/ Audit Global Update(s)
     4. Global Update – Draft / Review/ Approve
  9. Local Updates
     1. Create/ Add Local Update
     2. Manage Local Update
     3. View/ Disable/ Audit Local Update(s)/ +Interaction/ +Commitment/ +Obligation
  10. xEVMPD
      1. Manage xEVMPD Submissions
      2. View/ Audit xEVMPD Submissions
  11. CPP
      1. Create/ Add CPP Request
      2. View, Manage CPP
      3. Received CPP
      4. Audit/ Disable CPP(s)

5.2 Devices a. Registrations

1. Create/ Add Registration
2. Manage Registration
3. View/Disable/Audit Registration(s)
4. Registration – Draft / Review/ Approve
5. Interactions
6. Create/ Add Interaction
7. Manage Interaction
8. View/ Edit/ Disable/ Audit Interaction(s)
9. Commitments
10. Create/ Add Commitment
11. Manage Commitments
12. Edit/ Disable/ Audit Commitment(s)/ +Interaction
13. Obligations
    • 1. Create/ Add Obligations
      2. Manage Obligations
      3. Edit/ Disable/ Audit Obligation(s)/ +Interaction
14. Local Updates
15. Create/ Add Local Update
16. Manage Local Update
17. View/ Disable/ Audit Local Update(s)/ +Interaction/ +Commitment/ +Obligation
18. Substances
    1. Master File
    2. Applications
19. Reports
    1. General Reports
       1. Product Reports
          • Standard Reports
       2. Registration Reports
          • Registration Status Report
          • Marketed Registrations
          • Renewal Pending Registrations
       3. Manufacturing Reports
          • Manufacturing Reports
       4. SPOR Reports
          • SPOR Reports
       5. Compliance Reports
          • XEVMPD Reports
    2. Dynamic Reports
    3. Quality Check Reports
    4. MAS Reports
    5. Audit Trials
    6. Custom Reports
    7. Legacy Audit Trails
20. Batch Update
    1. Create and Manage Product Batch Updates
    2. Create and Manage Registration Batch Updates
21. Admin Settings
    1. Users
    2. Roles
    3. Library
    4. Settings

Definitions

1. Products Section: Using the Products module of SPAR, User can create a Master data of all the product information that enables you to store, maintain, and track product information. The information maintained in the Products module is pivotal for creating application and registration records for different countries. Usually Product Data will contain the Master, Common data Information. User can use the Products module to:

• Create and maintain all product information such as the Formulation, Packaging, Organizations, Associated Documents, and Therapeutic details, indications, contra indications, Undesirable effects, and Interactions.
• Create country specific Registration / Application records using the common product information.
• Have a quick summary view of all the Registrations associated to that product.

2. Device Section: Basic device details, physical characteristics, Batch information with its associated shelf life and storage conditions should be captured here. This information can be linked to a Product information when a product is associated with a device, thus it fields the need to manually enter a device information for all products that are associated with a device. 3. Documents Section: All documents that would be eventually needed for a registration shall be stored here and the related information can be added. 4. Submissions Section 4.1 Applications: Application Module is used for the process of submitting a product with all relevant information and obtaining an approval from the concerned authority. Only the Initial Application activity are tracked in Applications. 4.2 Sequences: For every application, a sequence could be created using Sequence module. 4.3 Dossiers: A ‘Dossier’ is a collection of documents with all the relevant information of a product to be submitted to health care authorities. The health care authorities usually specify different ‘folder structures’ of dossiers for submission. E.g., eCTD Structure 4.4 Registrations: A Product or a combination of products can have registrations in multiple countries. This section should allow the user to create a registration record for a product for multiple countries at a time. User should be able to later add country specific registration details to the registration record. Post-Approval / Registration Record always contains HA approved information. 4.5 Interactions: The Interaction module helps you view and track the interactions between the different actors, in the application. An Interaction can happen between Regulatory Agency and a Pharmaceutical Company or a third-party agency. 4.6 Commitments: A Commitment (RC) is a specific description of how a company intends to manufacture and control the drug product that is defined in the dossier, and that is subject to a regulatory action if changed after approval 4.7 Obligations: Obligations means standards, regulations, permits, or conditions required by a Governmental Authority. 4.8 Global Updates: Whenever a change is applicable globally/ Centrally, Global Update Module helps to define the Global change, perform impact assessment, and distribute the change as individual Local Updates records. 4.9 Local Updates: Local Update Module helps to define country specific changes or modify the changes distributed from the Global Team to meet the local requirements. Once the change submission set is finalized, you can assess the change impact on the relevant records and track the submission to authorities for approval. Changes (Approved / Submitted) impacting Registration data have to manually bring by users to Registrations. An LU is referred to as ‘Variation’ in European Union country and referred as ‘Supplements’ in the United States country. 4.10 xEVMPD: All medicinal products for human use authorized in the EU region, and marketing authorization holders shall, by 02-Jul-12 at the latest, electronically submit to the EMA information on all medicinal products for human use authorized or registered in the EU using the format defined by the EMA 4.11 CPPs: Certificate of pharmaceutical product can be created in the SPAR application. User(s) can assign the CPP request to the associate and update the current status in the CPP module. Upload the certificate. 5. Substance Section: Substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug, but the term does not include intermediates used in the synthesis of such substances. 5.1 Master File: Procedure, is to allow valuable confidential intellectual property or ‘know-how’ of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the Applicant or Marketing Authorisation (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance. 6. Reports Section: User can view different types of reports in this section and download. 7. Batch Update Section: User can update the attributes of Product(s) / Registration(s) in a batch or group. 8. Admin Settings Section: The Admin module allows the System Administrator to configure and maintain the SPAR Application.

Acronyms

ID	Identity
URL	Uniform Resource Locator
PSUR	Periodic Safety Update Report
MedDRA	Medical Dictionary for Regulatory Activities
SPAR	System for Products and Registrations
PDF	Portable Document File Format
HA	Health Authority
CPP	Certificate of Pharmaceutical Product
XEVMPD	Extended EudraVigilance Medicinal Product Dictionary
RMS	Reference Member State
CMS	Concerned Member States

Conventions

– Warnings/Cautions – Information which requires the user’s attention. – Notes – Information that gives additional details to the user. – Information that uses examples to explain, clarify, or justify.

References

This document was based on the functionalities of Freyr SPAR V5.0.0.

Freyr SPAR – Introduction

Freyr SPAR application enables Product Registration Information management and Submissions Management for Life Sciences. Life Science Organizations must register their Medicinal Products with Health Authority for approval. Each country has its own regulations which should be followed for receiving the approval. It is mandatory for the Life Science Organizations to fulfil the regulatory procedures of that country, to market its product. SPAR can be used as mentioned below:

• Track, monitor, and control all the Registration related activities of the Medicinal Products.
• Comply with the regulatory procedures of different countries during the course of Products Registrations.
• The application features a logical data management structure designed to contain and manage product information.
• “Assigned to” made available to incorporate business processes into the management of product data.
• Strong audit trail features to track and trace the changes made in the data ensuring regulatory compliance.
• End to End Submission management which covers submission lifecycle.
• Complete track of Health Authority interactions and response.
• Single repository for all the documents and augments seamless mapping to products.
• Customizable reports.
• Since Freyr SPAR is a web application, it is deployed from the development server to the client server on which the application will run. Browsers Compatible with the application are Chrome 56 & above and Edge 45 & above.

Login

Freyr SPAR application can be accessed using a browser that is compatible from any computer system using internet depending on the access policies of the organization. The Login screen is the initial screen which will be displayed when application is accessed using a URL. Below is the Login screen where user is prompted to enter his/her application credentials.

1. : Login window
2. To Login, Enter your Username and Password.
3. Click the button or hit Enter. User will be directed to the Home page.

If the User name or Password is incorrect, a message stating ‘Invalid credentials. You have 4 more attempt(s) before your account gets locked out.’ will be displayed. The number will decrease in the alert message as the user attempts to login-in for 5 times.

Forgot Password

If a user forgets password, they can reset it, provided they have access to the email address specified for their account. The process of resetting the password consists of the following steps in brief:

1. Click the link from the Login page. The Forgot Password window appears.
2. Enter the User Name.
3. Enter the CAPTCHA.
4. Click on ‘Send’ button.

1. : Retrieving password

An Email will be sent to the registered Email ID with reset password link. Upon clicking on the reset password link, user will be redirected to reset password page where user can enter new password. Below are the steps to follow:

1. Enter Password.
2. Confirm Password and Click on Save button.
3. By Clicking on the ‘Click Here’ link, user will be directed to the Login page.

If Password reset is successful, a message will display as ‘Your password has been reset successfully. ‘Please Click Here to continue’.

First Time Login Users

When user login for the first time in the application, the Set Password window pops up and prompts to change the password.

1. Enter the New Password and Confirm Password.

1. : Set Password Pop-Up For First Time Users
2. Click the button.

The password will be changed and user will be directed to the Set E-Signature Password window. Notes:

• The application password should be at least 8 characters in length; should have both uppercase and lowercase alphabetical characters and should have at least one numeric and one special character.

Password Complexity also can be managed or changed from Admin Settings>>Settings>>General Settings tab. User is mandated to set the E-signature password through the Set E-Signature Password window.

1. Enter the new E-signature password and confirm it.

1. : Set E-Signature Window
2. Click the button.

Your E-Signature password is saved. Notes:

• Your E-Signature password should be at least 8 characters in length should have both uppercase and lowercase alphabetical characters and should have at least one numeric and one special character.
• The E-Signature password and the Login password should not be the same.

Change in password complexity settings will also impact E-Signature password.

Session Expiry

Session expiry alert will help user understand that the current session has been expired and system will redirect them to the login screen. The following message get displayed. Usually this alert comes when user keeps the system idle more than the “session time out” in

1. Session expiry

Note : For SSO configured systems “session expiry” will be handled at SSO level.

Login through SSO

Freyr SPAR application can be accessed using a browser that is compatible from any computer system using internet depending on the access policies of the organization. The Sign in screen is the initial screen which will be displayed when application is accessed using a URL. Below is the Login screen where user is prompted to enter their email ID

1. : Sign In window – Email
2. To Sign in, Enter your email.
3. Click the “Next” button, user will be prompted to enter “Password”.

1. : Sign In window – Password
2. Enter Password and Click on “Sign in” shown in Figure-06 ,User will be directed to the Home page.
3. When user have multiple affiliates assigned , system will ask user to select the affiliate.

1. Fig: select affiliate pop up

NOTE: when Azure(SSO) configuration has been enabled > For E-signatures user must use the same password used at login. > Session Expiry time will be considered as per sso configuration.

Forgot Password

Contact your “Azure administrator” . ADO password has to be changed in order to change the password for SPAR.

Logout

To Logout from the application, click on name on the top right, the Logout link will display as shown in the Figure below.

1. Click on the Logout link.

1. : Logout option

User will be logged out of the application and page will be redirected to the below screen.

1. Azure SSO logout screen

Dashboard

Dashboard provides a graphical representation of the available Products with Product types and available Registrations. Also, Dashboards can be customized based on the Organization needs. When user login to the SPAR application, Dashboard homepage will be displayed as default page.

1. : Dashboard Page

Below are the features of Dashboard:

1. Reports Tab:

1. : Reports in Dashboard
2. Notifications list Tab:

1. : Notifications list In Dashboard

Following modules will be displayed beside notification list (Dropdown):

1. Obligations
2. Commitments
3. HA Queries
4. Products
5. Application (Global Plan)
6. Application (Local Plan)
7. Registrations
8. Global updates
9. Local updates

Select the respective module to check the notifications.

1. Notifications Tab:

1. : Notifications in Dashboard
2. UPCOMING INTERACTIONS: This widget shows the Interaction Dues along with response status based on ‘Response Due Date’ field in Interactions tab. The last 10, 20, 30,60 days details will be displayed by default.
3. UPCOMING REGISTRATION RENEWALS: This widget shows the Registration Renewal Dues and its status based on ‘Authorization Expiry date Renewal date’ field in Product Info from Registration Primary section. The last 10, 20, 30, 60 days details will be displayed by default.
4. UPCOMING PSUR SUBMISSIONS: This widget shows the Pending PSUR Submissions along with the status based on ‘Submission Date’ field in PSUR Status tab in Registration Secondary section. The last 10, 20, 30, 60 days details will be displayed by default.
5. UPCOMING COMMITMENTS: This widget shows the upcoming commitments along with the status based on ‘Due Date’ field in Commitments tab in Registration section. The last 10, 20, 30,60 days details will be displayed by default.
6. UPCOMING OBLIGATIONS: This widget shows the upcoming obligations along with the status based on ‘Due Date’ field in Obligations tab in Registration section. The last 10, 20, 30, 60 days details will be displayed.
7. My Tasks Tab:

1. : My Tasks in Dashboard
2. OBLIGATIONS TASKS: This widget shows the Obligation Tasks along with response status based on ‘Due Date’ field in Obligation tab.
3. COMMITMENTS TASKS: This widget shows the Commitments Tasks along with response status based on ‘Due Date’ field in Commitments tab.
4. INTERACTIONS TASKS: This widget shows HA Interactions Tasks along with response status based on ‘Due Date’ field in HA Interactions Tasks tab.
5. LOCAL UPDATES TASKS: This widget shows recent Local Updates Tasks along with response status based on ‘Local Updates Tasks’ field in Local updates tab.

Note: Tasks marked with status “Completed” will be removed from “My tasks” as it is user specific.

1. Tasks List Tab:

1. : Tasks Lists in Dashboard
2. OBLIGATIONS TASKS: This widget shows the Obligation Tasks and Subtask along with status ‘Assigned, In-Progress, completed’ and based on ‘Status’ field in Obligation tab.
3. COMMITMENTS TASKS: This widget shows the Commitments Tasks and Subtask along with status ‘Assigned, In-Progress, completed’ and based on ‘Status’ in Commitments tab.
4. INTERACTIONS TASKS: This widget shows HA Interactions Tasks and Subtask along with status Assigned, In-Progress, completed’ and based on ‘Status’ in HA Interactions Tasks tab.
5. LOCAL UPDATES TASKS: This widget shows recent Local Updates Tasks with Assigned, In-Progress, completed’ and based on ‘Status’ in Local updates tab.

Note: By default user will see only last 30 days of Tasks in “Tasks list”

1. Registrations by Country Groups: The user can view ‘Number of Registrations’ created by hovering the mouse on specific region.

1. : Registrations by Country Groups in Dashboard

Note: The colored region on the map indicates the presence of Registration(s). The Grey color indicates that no Registrations were created so far and are subjected to change based on user’s Country Preferences.

1. Registrations by Procedure in All Country Groups : User can view a pie chart showing number of registration records created based on Procedure.

1. : Procedure Pie Chart in Dashboard
2. Products by Type: User can view a pie chart showing number of registration records created based on Product type.

1. : Products Type Pie Chart In Dashboard
2. Products by Status: User can view a pie chart showing number of Products Status records created based on Product type.

1. : Products By Status Pie Chart In Dashboard

My Profile

The My Profile allows user to view User Details and update the details such as:

1. Change Password
2. Change E-signature Password
3. Change Username

Below are the steps to follow:

1. Click the Name dropdown on the top right of home page.
2. User will see links for My Profile and Logout.

Clicking My Profile will let user view details in a non-editable format as shown in the Figure.

1. : Viewing Account Details

Change E-Signature Password

User can change E-Signature password through the My Profile page. To change your password, click the E-Signature button.

1. : Reset E-Signature

The Reset E-Signature window pops up.

1. Enter your current E-signature password.
2. Enter your new E-signature password and confirm it.
3. Click the button.

The message ‘E-Signature updated Successfully’ is displayed.

• Note:

Click the button to discard the changes.

Change Password

User can change Application (login password) through the My Profile page. To change your password, click the Change Password button.

1. : Reset Password Dialog Box

The Reset Password dialog box pops up.

1. Enter your Current password.
2. Enter your new password and confirm it.
3. Click the button.

The message ‘Password updated Successfully’ will be displayed. Note:

• Click the button to discard the changes.

Change User Name

User can change the User Name through the My Profile page. To change your User Name, click the Change User Name button.

1. : Update User Name

The Update User Name window pops up.

1. Enter your new User Name.
2. And Click the button.

The message ‘User Name updated successfully’ is displayed. Note:

• Click the button to discard the changes.

Adding My Preferences

My Preferences let the user decide the which country information they want to see in the Submission Module. Based on their selection data will be shown in Submission module which includes (Applications, Registrations, Sequences, Dossiers, Local update).

1. : My preferences

1. : My preferred Country(s) pop up

Note : All Countries selection will not be having any restrictions and user will see all country information. Selected Preferred Country(s) will allow user to show only selected country submission information

Logout

To Logout from the application, click on name on the top right, the Logout link will display as shown in the Figure below.

1. Click on the Logout link.

User will be logged out of the application and page will be redirected to the Login page.

1. : Logout Link

Help

Help option allows user to open the user guide.

Products

Login to the application and click on the Products tab from the side menu bar. Products home page will be displayed as shown in the below screen.

1. : Products Homepage

Note: User will see some or all buttons listed out above, based on the role specific functions. Example: A assigned Reviewer user will see ‘Review ‘option in enable mode under Actions. For reviewer ’Assigned to’ and ‘Approve’ options will be in disabled mode.

Add a Product

Business Administrator role users can add Product information based on Product Category such as ‘Marketable or Investigational’. Click on ‘+Product’ to open Add Product window as shown in the below screen.

1. : Add Product

To add the Product, below are the steps to follow:

1. Click the ‘+Product’ icon in Product Homepage, ‘Add Product’ page will open.
2. Select the ‘Product Category’, dropdown and ‘Type’ dropdown.
3. . Select the’ Product Subcategory’ dropdown and ‘Type’ dropdown
4. Select the ‘Type’ dropdown and choose the Type.
5. Enter the Name of the product

6. Select Inactive’ check box to make the product as inactive (if required) 7. Select ‘Include devices’ to link the devices from the devices module with the product. 8. If the Product Sub Category selected as Combination/Reconstituted then it appears as Combined Pharma form OR if the Product Sub Category as Simple then it appears as Mfg./Administrable Dosage Form. 9. Select ‘Product Family’ from the dropdown. 10. Enter all the mandatory Product information and click ‘Save’ button to save the record. 11. Click ‘Cancel’ to exit the page without saving the information or ‘Reset’ buttons to clear the entered information. 12. After successful creation of the product, system will list the product in Products Home page. 13. If Product category is ‘Marketable’ then Marketable Product will be created along with selected details. 14. If Product category is ‘Investigational’ then Investigational Product will be created along with selected details. 15. The created Product record will display in Products listing.

Favorite’s Listing

shows the Products which are marked as favorite in the listing. To add the Products in Favorite View:

1. Click on the favorite icon of the single or multiple products.
2. Click on
3. The selected favortie products will be displayed in My Favorites tab.

1. : ‘My Favorite’ tab

Include Inactives Listing

User can view inactive Products in the listing.

1. Select ‘Include Inactive’ check box to view inactive records as shown below.
2. The inactive record row will be displayed in red highlig
3. : Inactive Product records Listing

Disabled records Listing

User can view Disabled Products in the listing.

1. Select ‘Disabled Records’ check box to view disabled records as shown below.
2. The ‘Disabled Records’ row will be displayed in pink highlight

1. : Disable Product records Listing

Manage a Product

Business Administrator role users can enter Protocol, Formulation, Therapeutic Details, Packaging, Organization(s), Associated Documents, Registrations, and Interactions for a product through Manage button. User can also add/link any device details if the Product contains a device.

1. : Manage Product

Below are the steps to follow to Manage a product.

1. Select a Product record in the Product homepage and click the ‘Manage’ button from Actions option.
2. The widgets of Formulations, Therapeutic Details, Packaging, Organization(s), Devices, Associated Documents, Registrations and Interactions will display in the Manage page.
3. Click on the record count in the widget(s) , the page will be navigated to the specific section.
4. In Manage page Left-hand side ,expand the Products to view the following tabs.
5. Basic Information
6. Protocol– (Tab will display if ‘Product Category’ is selected as Investigational during product creation)
7. Formulations
8. Therapeutic Details
9. Packaging
10. Organization(s)
11. Devices – (Tab will display if ‘Include Devices Checkbox’ is not selected during product creation)
12. Associated Documents
13. Registrations
14. Interactions

Add Basic Information

Basic Information tab shows the details of the Product captured at creation. To access the Basic Information, go to Products >>>> select a record >>>> Manage >>>> Basic information as per the below figure:

1. : Navigating to Basic Information

Basic information section includes attributes such as Mfg/Administrable Dosage form Product Family, Business Unit, International Birth Date, Development International Birth Date (applicable for Investigational Products), Type of combination product(available only when include device check box is marked) etc. Also allows user to add Active ingredients list, Route of Administration, Brand name, Responsible person. For Reconstituted and Combination Product user need to add the included Products required.

1. Basic Information: Simple Product

1. : Route of Administration

1. : Brand Name Grid

1. : Responsible Person

Add Protocol Information

User can add Protocol details for a Product. The tab will display only for the Investigational records. Click on Protocol tab, user will be directed to the below screen.

1. : Protocol Page

To add the protocol data, below are the steps to follow:

1. Select Product record with ‘Product Category’ as Investigational and click Manage from Actions.
2. From Left-hand side menu. expand Products.
3. Click the Protocol tab.
4. Click . Tab and click +Protocol information as per below screen

1. : Add Protocol
2. The DUNS Number, IDMP ORG CODE, Address, Geographic Coordinates, Confidential fields will auto-populated based on Sponsor dropdown selection.
3. Enter all the relevant fields ‘Protocol Number’, ‘Phase’, ‘Study Type’ and Study Title’ .
4. Click ‘Save’ button to save the record.
5. Click Actions to view Edit, Disable and Audit buttons.
6. Click button, enter the data and click Save button to update the data.
7. Click button to remove the record.
8. When Disable button is clicked, an alert message will display with OK and Cancel buttons.
9. Click OK button, the added record will be Disabled from the listing.
10. Click Audit button , a popup will display to view all the audit data.
11. When ‘Cancel’ button is clicked, the page will exit without saving the information.

Note: Edit, disable, Audit functionality is common in all the tabs of Manage Products. Add Associated Study Numbers User can add the “Associated Study Numbers” by clicking on as shown in below screen

1. : Adding Associated Study Numbers

Up on clicking the button, user will be directed to “Add Associated study Numbers Screen” where user can enter data for the following fields:

1. : Add Associate Study Numbers

Request a New protocol To request a new protocol to work on, user need to Click on tab and go for the following add button.

1. : New Request button

After clicking on +New Request, user can upload the template in “New Request” Page as per below screen by clicking on and .

1. : Request New Protocol

Assigning a Protocol template To assign a protocol template, user need to upload the template as described in 5.4.2.2. Request a New Protocol. Once the template has been uploaded , “Assign to” tab will be enabled . User can click on as per below screen. 1. Clicking on system will direct to following screen:

1. : Assign to Page

User can fill up the required fields and click on to add an assignee.

Add Formulations

User can add Formulation details for a Product. Click on the Formulation tab and click toggle menu available on the left side of the screen. The Formulations divided into various segments as shown below:

• Composition
• Physical characteristics
• Other characteristics

1. : Formulation Page

When User Select “”Formulation” under Product at LHN , user will see Formulation page with following features:

1. A grid with four columns Record ID,Formulation, Description, Countries and Version.
2. Buttons + Formulation, Actions(Edit, Disable, Audit , Version, Clone)
3. The Toggel menu displaying all the formulation names associated with the product.
4. Each formulation will have Composition, Physical Characteristics and Other Characteristics sections.

1. : Add Formulation

To add Formulation below are the steps to follow:

1. Click .
2. ‘Add Formulation’ page will open.
3. Enter the field Formulation, other field information and click ‘Save’ button to save the record.
4. User can add multiple records if required.
5. Click ‘Cancel’ to exit the page without saving the information.
6. When user clicks “+Version” he/she will see a popup with message “Are you sure you want to create a new version for formulation(s)?” with OK and Cancel buttons.
7. When user clicks Ok, the ‘Version 1’ record will be upgraded to ‘Version 2’ in the grid, user will view the new version record in the grid.
8. Clone option will be given for formulation to ease the process of creation of new formulation which is similar to the existing one. After cloning the record user will modify it according to new formulation requirement.

1. : Formulation with Clone and Version

Expand the Toggle menu, under each formulation in the list, links for Composition, Physical Characteristics and other Characteristics will display.

Composition

1. Click Composition link.
2. The page will be directed to composition to add information about the compositions, Substances and Reference Substances that make up the composition for a formulation.

1. : Composition Page
2. Enter the relevant information in Composition, Active Substances, Excipients, Pharmaceutical Product, Strength and Reference Substance and click Save button.

Physical Characteristics

1. Click Physical Characteristics.
2. The page will be directed to the Physical Characteristics page.
3. Click
4. Enter the relevant information and click Save button.

1. : Add Physical Characteristics Page

Other Characteristics

1. Click Other Characteristics link.
2. The page will be directed to Other Characteristics to add information for a formulation.

1. : Add Other Characteristics Page
2. Enter the relevant information and click Save button.

Add Therapeutic details

User can add Therapeutic details for a Product. Click Therapeutic details tab and click the toggle available on the left side of the screen. The Therapeutic details is divided into various segments as shown below:

• Indications
• Contraindications
• Undesirable Effects
• Interactions

1. : Therapeutic Details Toggle Menu Page

Indications By default, Indications page will display. To add Indications below are the steps to follow:

1. Click .
2. Add Indication form will be available, Enter the relevant information and click Save.
3. Once Indication is added, then user will be allowed to add ‘Indication details, Co-morbidity details, Specifics’ for an indication record.
4. Enter Indication details, Co-Morbidity details and Specifics information using the , and buttons respectively.
5. Once User enter Indication details, User will be allowed to enter the disease status and intended effects for the Indication.
6. Enter Disease Status and Intended effects using and

1. : Indications Page
2. Click Save button after entering the data.

Expand the Toggle menu, links for Contraindications, Undesirable Effects and Interactions will display. Contraindications To add Contraindications below are the steps to follow:

1. Click Contraindication in the toggle menu, Click
2. Add Contraindication form will be available, Enter the relevant information and click Save.
3. Once Contraindication is added, then user will be allowed to add ‘Contraindication details, Co-morbidity details and Specifics for that contraindication record.
4. Enter Contraindication details, Co-Morbidity details and Specifics information using the , and buttons respectively.
5. Once User enter Contraindication details, User will be allowed to enter the disease status for the Contraindication.
6. Enter Disease Status details using .

1. : Contraindications Page
2. Click Save button after entering the data.

Undesirable Effects To add Undesirable Effects below are the steps to follow:

1. Click Undesirable effects in the toggle menu, Click
2. Add Undesirable Effects form will be available, Enter the relevant information and click Save.
3. Once Undesirable Effect is added then user will be allowed to add Undesirable Effects details for that record.
4. Enter Undesirable effects details, using the button.

1. : Undesirable Effects Page
2. Click Save button after entering the data.

Interactions To add Interactions below are the steps to follow:

1. Click Interactions in the toggle menu, Click .
2. Add Interaction text form will be available, Enter the relevant information and click Save.
3. Once Interaction text is added, User will be allowed to add Interactions details for that record.
4. Enter Interactions details using the button.

1. : Interactions Page
2. Click Save button after entering the data.

Add Packaging Details

User can add Packaging details for a Product. Click Packaging tab and click the toggle available on the left side of the screen. The Packaging is divided into various segments as shown below:

• Primary Pack
• Add Packaging (e.g.: Secondary Pack)
• 

1. : Packaging Page

Primary Pack By default, Primary pack page will display. To add Primary Pack below are the steps to follow:

1. Click .
2. Add Primary Pack form will be available, Enter the relevant information and click save button.

1. : Add Primary Pack Form
2. Once Primary Pack is added then user will be allowed to add below tabs.
3. Batch Details
4. Shelf-Life

• Storage Conditions

1. Physical Characteristics
2. Other Characteristics
3. Data carrier Identifier
4. Component

• Physical Characteristics

1. Enter all the details using the ‘+Batch Details’, ‘+Physical Characteristics’ etc., buttons and save the records.
2. The details will be added to the Product.
3. Click ‘Cancel’ to exit the page without saving the information
4. When user clicks “+Version” he will see a popup with message “Are you sure you want to create a new version for formulation(s)?” with OK and Cancel buttons.
5. When user clicks Ok, the ‘Version 1’ record will be upgraded to ‘Version 2’ in the grid, user must view the new version record in the grid.

Add Packaging (e.g.: Secondary Pack)

1. Expand the toggle menu, click ‘+Add Packaging’ on the left side of the screen.
2. Add different packages like Secondary, Tertiary etc., enter all the information and click Save.

1. : Add Packaging Page
2. Once User add secondary pack, User need to enter below details and save the record.
   1. Batch Details
   2. Shelf-Life

• Storage Conditions

c. Physical Characteristics d. Other Characteristics e. Data carrier Identifier f. Component

• Physical Characteristics

1. : Secondary Pack Page

Add Organization(s)

User can add organization details for a Product. Click on the Organization(s) tab and click toggle menu available on the left side of the screen. The Organization(s) is divided into various segments as shown below:

1. Manufacturing sites
2. Distributor

1. : Organizations Page

Manufacturing By default, Manufacturing sites page will display. To add Manufacturing sites below are the steps to follow:

1. Click .
2. Add Manufacturing Sites form will be available, Enter the relevant information and click Save.

1. : Add Manufacturing Sites Form
2. Once Manufacturing site record is added, user will be able allowed to add the below tabs.
3. Contact Details
4. Manufacturing Operation
5. Other Locations
6. Approved By
7. Certificates
8. Enter the relevant details and save, the records will be saved in Organization Library

Distributor To add Distributor below are the steps to follow:

1. Click .
2. Add Distributor form will be available, Enter the relevant information and click Save.

1. : Add Distributor Form
2. The DUNS Number, IDMP Org Code Address, Geographic Coordinates, Confidential Indicator fields will auto-populated based on Name dropdown selection.
3. Once Distributor record is added, user will be able allowed to add the below tabs.
4. Contact Details
5. Other Locations
6. Business Operation
7. Medicines Regulatory Agency
8. Enter all the details and save, the records will be saved in Organization Library

Add Device

The Devices tab will be visible only when user select ‘Include Devices’ check box, while creating or adding a Product record or managing a Product record to include Devices. It will be used to store the Device related data for each Product. Devices section grid will show ‘No records to display’ unless the device is searched and added to the section. To add Devices below are the steps to follow:

1. Click Devices tab.

1. : Add Product Devices Screen
2. Page will be redirected to the ‘Product Devices’ as shown in the below screen.

1. : Product Devices Page
2. Click .
3. Page will be redirected to ‘Search Devices’ screen.

1. : Search Devices Page
2. Enter a value in the Search field, Select an Operator and enter a Search Value then click on Search.
3. Select button to enter multiple fields to search.
4. If Product Devices Screen shows ‘No records to display’ then click on to add Devices as shown in the below screen.

1. : Add New Devices Screen

8. Then page will be redirected to the Device main module as shown in the below screen.

1. : Add Devices Page

9..If Devices are available with searched criteria; the results will be displayed in ‘Product Devices’ section as shown in the below screen.

1. : Search Devices Results Screen

10. Select the Devices checkbox and click on Link Devices. 11. User can select multiple Devices if required. 12. When User clicks on button, page will be redirected to the Select Device Details Screen.

1. : Select Device Details Screen

13. Select the checkbox to link the relevant Device details. 14. Click ‘Save’ or ‘Save and Close’ button. 15. The selected Device will be added to the ‘Product Device’ page as shown below.

1. : Added Devices Screen

5.5.8.1 Manage Product Device User can use this option to change or edit the Device details that are added to the Product. To Manage Device below are the steps to follow:

1. Select a Device, click on Manage.

1. : Product Devices Screen
2. Page will be redirected to the ‘Select Device Details’ screen.
3. This screen will have two buttons; Edit and Close.

1. : Manage Select Devices Screen
2. The current Device details will be displayed in view mode and if any changes are needed user can click the ‘Edit’ button.

1. : Select Devices Screen Through Manage
2. Select or unselect the necessary details and click Save, the modifications will be updated to the product device.
3. To unlink this Device unclick device checkbox and click on save and close as shown in the below screen.

1. : Unlink Device from Select Device Details Screen
2. To unlink existing Device from Product Devices Screen select Record ID and click on ‘Unlink Device’ under Actions button as shown in the below screen.

1. : Unlink Device from Product Devices Screen

8. Click on Show Unlinked Records Checkbox to view Unlinked Records.

Associated Documents

User can add Associated Documents for a Product. Click on Documents tab, user will be directed Associated Documents page as shown in the below screen.

1. : Documents Homepage

Add Document To add Document below are the steps to follow:

1. Click icon in Document Homepage.
2. ‘Upload Documents’ Dialog box will open as shown in the image.

1. : Upload Documents –Add Documents Popup
2. The first page in the wizard allows to sect the file(s) to upload. User can Select one or more files to upload.
3. Click ‘Select files’, select the document to upload
4. Click ‘Select files’ again to select another document if needed.
5. The documents can be uploaded from File share, DMS application or SharePoint.
6. If user click DMS, the page will be re-directed to the DMS application.
7. Once the files are uploaded, the page will be directed to ‘Document Properties’ as shown in the image.

1. : Document Properties Popup
2. The document name will be displayed on the top. If two documents are uploaded, user will see two tabs and so on.
3. Enter the relevant information for the relevant document and click Save.
4. The document will be added to the list of documents in the homepage.
5. User can also use button to add the documents.

1. : Select Documents Page Using Link Existing Document Option
2. Select the document and click on Attach. The document will be added to the list of documents in the homepage.
3. Click to add documents from DMS. The page will be redirected to the DMS application Login page.
4. Click Edit button to edit the Document Properties.
5. Click button to delete the document from the listing.

View and Manage Associated Registrations

Click on Registrations tab, user will be directed Registrations page where user can see all the Registrations entered for that particular Product as shown in the below screen. To Manage Registraton below are the steps to follow: (Note: Registrations tab will be visible only when Product Category is selected as Marketable) 1. Select one Registration Id and click on Manage button as shown in the below screen.

1. : Registrations Page

Manage Registrations

To Manage Registraton below are the steps to follow:

1. Select one Product and click on Manage button, page will be directed to the Registration.

1. : Manage Registrations Page
2. Enter all the relevant information and click ‘Save’ button to save the record.
3. Click ‘Delete’ button to delete the item or ‘Reset’ buttons to clear the entered information.

Interactions

User can Manage Interactions for that particular product. Click on Interactions tab, user will be directed Interactions page as shown in the below screen.

1. : Interactions Page

To Manage Interactions below are the steps to follow:

1. The list of all the Interactions entered for that particular product will display in the listing.

1. :Manage Interaction
2. Select an Interaction from the list and click on Manage button, page will be directed to Interaction Details page as shown below.

1. : Health Authority Interactions Details Page
2. User can add Cycles if needed.
3. User can view a toggle menu on the left-hand side of the screen which contains added cycles for a HA Interactions record.
4. Enter all the relevant information and click ‘Save’ button to save the record.

View button in Products grid.

1. When user clicks “View” button on the Products home page, here will see the following options:

1. : View button in Product Grid
2. Dropdown. – The Name drop down list must display with all the Product Names and upon selecting product name in the tree view, User must view below details in the left side pane.
3. Protocol Information (Visible only when Product Category is selected as Investigational)
4. Formulations(Numeric Count)
5. Therapeutic Details
   • 1. Indications(Numeric Count)
     2. Contraindications(Numeric Count)
     3. Undesirable Effects(Numeric Count)
     4. Interaction(Numeric Count)
6. Packaging
7. Primary Pack(Numeric Count)
8. Secondary Pack(Numeric Count)
9. Tertiary Pack(Numeric Count)
10. Organization Library Details
11. Manufacturing Sites(Numeric Count)
12. Distributor(Numeric Count)
13. Devices(Numeric Count)
14. Registrations(Numeric Count)
15. Interactions
16. When user click Formulation, the formulations data will display in the right side pane for view and similarly for other fields in the tree view, data will populate in the right side pane.
17. User can export the data with ‘Export to PDF’ option.
18. Back button will be redirected back to the Products grid.

1. : View Page – Product

Clone a Product

To clone a Product user, need to Select the Required Product Record from the Grid and click on Clone button as shown in the below figure:

1. : Cloning a Product

After clicking on Clone button following pop up will appear:

1. : Clone Product Pop up

Users need to select the required mandatory fields and click on “save” button. A product record cloned with other attributes (Formulation, Therapeutic details etc.) shall be populated. Notes:

• Data available in DIBD and IBD attributes should not be copied to the cloned record.

Batch Update

To add Products in Batch Update, Follow the below steps: 1. Select the Required products from the Product Grid 2. Click on “Batch Update” from Actions

1. : Adding Products to Batch Update

System will only allow Products of Same category and Status to be selected in a Batch 3. Batch update pop up comes up after Clicking on Batch Update.

1. : Batch Update Pop up

4. Fill up the above fields click on save button. Record will be created in Batch Update module with the same batch.

1. : Record Updated at Batch Update Grid

Disable a Product

To disable a product refer the section 14.6.

Map to affiliate

To map a Product to an affiliate refer section 14.10.

Assign a Product.

To Initiate a workflow for Product refer section 13

Devices

Clicking on Devices tab, user will be directed to the Devices homepage as shown in the below screen.

1. : Device Home Page

The following information will display on the page:

1. A list of all the Devices items that have been added.
2. Buttons +Device, Manage, Edit, Disable and Audit.

User will be able to perform the following functions using this screen:

1. Add a Device using
2. Add additional details for a device such ‘Basic Details Model, Packaging, Therapeutic details and Organization Library and Associated Document’ using button.
3. Edit a device using button.
4. Disable a device using button.
5. Audit option to view audit details.

Add a Device

1. Click the ‘+Device’ icon in Device Homepage.

1. :Add Device Option
2. ‘Add Device’ page will open.
3. Enter the Device information and click ‘Save’ button to save the record.

1. : Add Device Page

Click ‘Cancel’ to exit the page without saving the information. 4. After successful creation of the Device, system will list the Device in Devices Home page as shown in the below screen

1. Devices Home Page

Manage a device

User can enter Basic details information such as Physical Characteristics, Batch details, Shelf Life, Storage Conditions & Other Characteristic for a device through the Manage button. And additionally, Organization Library details such as Manufacturing site and distributer can be added and Document associated to respective device can be linked. Below are the steps to follow to Manage a device.

1. Select a record in the Device homepage and click the ‘Manage’ button.

1. Device Home Page
2. The page will be directed to the Basic info Details page as shown below.

1. : Manage Device Page

3. In Manage page Left-hand side, expand Devices to view the below tabs. a. Basic Details b. Model c. Packaging d. Therapeutic Details e. Organization(s) f. Associated Documents

Add Basic details

Basic info details information for the device, will be shown in the read only format.

1. Select the Basic Info details , .

1. Devices Basic Details Page
2. Enter the relevant information and click ‘Save’ button to save the record.

Add Model

To add Device Model information for the device, below are the steps to follow:

1. Click the “Model” button.

1. Model Page
2. “Model” “ page will open.

1. : Add Model Pop up

Enter relevant information and click on ‘Save’ to save the record. Click ‘Cancel’ to exit the page without saving the information. a. Identifier i. Click on ‘+ Identifier’ icon then page will be directed to ‘Add Identifier’ page as shown in the below screen.

1. : Add Identifier Pop up

ii. Enter relevant information and click on ‘Save’ to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. b. Shelf Life i. Click on ‘+ Shelf Life’ icon then page will be directed to ‘Add Shelf Life’ page as shown in the below screen.

1. : Add Shelf Life Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. c. Storage Conditions i. Click on ‘+ Storage Conditions’ icon then page will be directed to ‘Add Storage Conditions’ page as shown in the below screen.

1. : Add Storage Conditions Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. d. Physical Characteristics i. Click on ‘+ Physical Characteristics’ icon then page will be directed to ‘Add Physical Characteristics’ as shown in the below screen.

1. : Add Physical Characteristics Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. e. Data Carrier Identifier i. Click on ‘+ Data Carrier Identifier’ icon then page will be directed to ‘Add Data Carrier Identifier’ as shown in the below screen.

1. : Add Data Carrier Identifier Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. f. Component i. Click on ‘+ Component’ icon then page will be directed to ‘ Add Component’ as shown in the below screen.

1. : Add Component Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. g. Physical Characteristics (Component Physical Characteristics) i. Click on ‘+ Physical Characteristics’ icon then page will be directed to ‘Add Component Physical Characteristics’ as shown in the below screen.

1. : Add Component Physical Characteristics Pop up

Add Packaging

To add Device Packaging Details information for the device, below are the steps to follow:

1. Click the ‘Packaging’ section then ‘Packaging>> Primary Pack ‘page will open as shown in the below screen.

1. : Devices Packaging Page
2. User can add the below details such as:

a. Primary Pack i. Click on ‘+ Primary Pack’ icon page will be directed to ‘Add Primary Pack’ page as shown in the below screen.

1. : Add Primary Pack Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. b. Batch Details i. Click on ‘+ Batch Details’ icon page will be directed to ‘Add Batch Details’ page as shown in the below screen.

1. : Add Batch Details Pop up

c. Shelf Life i. Click on ‘+ Shelf Life’ icon page will be directed to ‘Add Shelf Life’ page as shown in the below screen.

1. : Add Shelf Life Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. d. Storage and Handling i. Click on ‘+ Storage and Handling’ icon page will be directed to ‘Add Storage and Handling’ page as shown in the below screen.

1. : Add Storage and Handling Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. e. Physical Characteristics i. Click on ‘+ Physical Characteristics’ icon then page will be directed to ‘Add Physical Characteristics’ as shown in the below screen.

1. : Add Physical Characteristics Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. f. Other Characteristics i. Click on ‘+ Other Characteristics’ icon then page will be directed to ‘Add Other Characteristics’ as shown in the below screen.

1. : Add Other Characteristics Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. g. Data Carrier Identifier i. Click on ‘+ Data Carrier Identifier’ icon then page will be directed to ‘Add Data Carrier Identifier’ as shown in the below screen.

1. : Add Data Carrier Identifier Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. h. Component/Accessories i. Click on ‘+ Component/Accessories’ icon then page will be directed to ‘Add Component’ as shown in the below screen.

1. : Add Component Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. i. Physical Characteristics (Component) i. Click on ‘+ Physical Characteristics’ icon then page will be directed to ‘Add Component Physical Characteristics’ as shown in the below screen.

1. : Add Component Physical Characteristics

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. 3. After adding Primary pack details then click on Toggle menu then click on ‘+ Add Packaging’ to add Secondary pack details as shown in the below screen.

1. : Add Device Packaging

4. Enter relevant information and click on ‘Save’ to save the record.

1. : Device Secondary Pack Page

For further actions refer to section 6.2.3 Packaging>>Primary Pack Details

Add Therapeutic Details

To add Therapeutic Details information, below are the steps to follow: Click ‘Therapeutic Details’ then ‘Therapeutic Details>> Indication’ page will open as shown in the below screen.

1. : Devices Therapeutic Details Page
2. Indications

User can add below details under Indications such as:

• 1. Indications
  2. Indication details
  3. Co-morbidity details
  4. Specifics
  5. Disease Status Details
  6. Intended Effect Details

a. Indications i. Click on ‘+ Indications’ icon page will be directed to ‘Add Indication’ page as shown in the below screen.

1. : Add Indication Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. b. Indication details i. Click on ‘+ Indication details’ icon page will be directed to ‘Add Indication details’ page as shown in the below screen.

1. : Add Indication details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. c. Co-morbidity details i. Click on ‘+ Co-morbidity details’ icon page will be directed to ‘Add Co-morbidity details’ page as shown in the below screen.

1. : Add Co-morbidity details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. d. Specifics i. Click on ‘+ Specifics’ icon page will be directed to ‘Add Specifics’ page as shown in the below screen.

1. : Add Specifics Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. e. Disease Status details i. Click on ‘+ Disease Status details’ icon page will be directed to ‘Add Disease Status details’ page as shown in the below screen.

1. : Add Disease Status details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. f. Intended Effect details i. Click on ‘+ Intended Effect details’ icon page will be directed to ‘Add Intended Effects details’ page as shown in the below screen.

1. : Add Intended Effects details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. 2. Contraindications User can add below details under Contraindications such as: a. Contraindications b. Contraindication details c. Co-morbidity details d. Specifics e. Disease Status details a. Contraindications i. Click on ‘+ Contraindications’ icon page will be directed to ‘Add Contraindications’ page as shown in the below screen.

1. : Add Contraindications Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. b. Contraindication details i. Click on ‘+ Contraindication details’ icon page will be directed to ‘Add Contraindication details’ page as shown in the below screen.

1. : Add Contraindication details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. c. Co-morbidity details i. Click on ‘+ Co-morbidity details’ icon page will be directed to ‘Add Co-morbidity details’ page as shown in the below screen.

1. : Add Co-morbidity details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. d. Specifics i. Click on ‘+ Specifics’ icon page will be directed to ‘Add Specifics’ page as shown in the below screen.

1. : Add Specifics Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. e. Disease Status details i. Click on ‘+ Disease Status details’ icon page will be directed to ‘Add Disease Status details’ page as shown in the below screen.

1. : Add Disease Status details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. 3. Undesirable Effects User can add below details under Undesirable Effects such as: a. Undesirable Effects b. Undesirable Effects details a. Undesirable Effects i. Click on ‘+ Undesirable Effects’ icon page will be directed to ‘Add Undesirable Effects’ page as shown in the below screen.

1. : Add Undesirable Effects Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. b. Undesirable Effects details i. Click on ‘+ Undesirable Effects details’ icon page will be directed to ‘Add Undesirable Effects details’ page as shown in the below screen.

1. : Add Undesirable Effects details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. 4. Interactions User can add below details under Interactions such as: a. Interactions b. Interactions details a. Interactions i. Click on ‘+ Interaction Text’ icon page will be directed to ‘Add Interaction Text’ page as shown in the below screen.

1. : Add Interaction Text Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. b. Interactions details i. Click on ‘+ Interactions details’ icon page will be directed to ‘Add Interactions details’ page as shown in the below screen.

1. : Add Interactions details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information.

Add Organization(s)

Manufacturing Site: To add Organization(s) details information below are the steps to follow: Click on Organization(s) tab and click on toggle menu to Add Manufacturing details as shown in the below screen.

1. : Devices Manufacturing Page

User can add following details under Manufacturing such as Manufacturing Sites, Contact Details, Manufacturing Operation, Other Locations, Approved By, Contact Details, Certificates (GMP, DMF). a. Manufacturing Sites i. Click on ‘+ Manufacturing Sites’ icon page will be directed to ‘Add Manufacturing Sites’ page as shown in the below screen.

1. : Add Manufacturing Sites Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. b. Contact Details i. Click on ‘+ Contact Details’ icon page will be directed to ‘Add Contact Details’ page as shown in the below screen.

1. : Add Contact Details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. c. Manufacturing Operation i. Click on ‘+ Manufacturing Operation’ icon page will be directed to ‘Add Manufacturing Operation’ page as shown in the below screen.

1. : Add Manufacturing Operation Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. d. Other Locations i. Click on ‘+ Other Locations’ icon page will be directed to ‘Add Other Location’ page as shown in the below screen.

1. : Add Other Location Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. e. Approved By i. Click on ‘+ Approved By’ icon page will be directed to ‘Add Approved By’ page as shown in the below screen.

1. : Add Approved By Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. f. Contact Details (for Approved By) i. Click on ‘+ Contact Details’ icon page will be directed to ‘Add Contact Details’ page as shown in the below screen.

1. : Add Contact Details (for Approved By) Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. g. Certificates (GMP) i. Click on ‘+ GMP’ icon page will be directed to ‘Add GMP Certificate’ page as shown in the below screen.

1. : Add GMP Certificate Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. h. Certificates (DMF) i. Click on ‘+ DMF’ icon page will be directed to ‘Add DMF Certificate’ page as shown in the below screen.

1. : Add DMF Certificate Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. Distributor: Click on Organization(s) tab and click on toggle menu to Add Distributor details as shown in the below screen. .

1. : Devices Distributor Page

User can add following details under Distributor such as Distributor, Contact Details, Other Locations, Business Operation, Medicines Regulatory Agency and Contact Details. a. Distributor i. Click on ‘+ Distributor’ icon page will be directed to ‘Add Distributor’ page as shown in the below screen.

1. : Add Distributor Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. b. Contact Details i. Click on ‘+ Contact Details’ icon page will be directed to ‘Add Contact Details’ page as shown in the below screen.

1. : Add Contact Details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. c. Other Locations i. Click on ‘+ Other Locations’ icon page will be directed to ‘Add Other Location’ page as shown in the below screen.

1. : Add Other Location Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. d. Business Operation i. Click on ‘+ Business Operation’ icon page will be directed to ‘Add Business Operation’ page as shown in the below screen.

1. : Add Business Operation Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. e. Medicines Regulatory Agency i. Click on ‘+ Medicines Regulatory Agency’ icon page will be directed to ‘Add Medicines Regulatory Agency’ page as shown in the below screen.

1. : Add Medicines Regulatory Agency Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information. f. Contact Details (for Medicines Regulatory Agency) i. Click on ‘+ Contact Details’ icon page will be directed to ‘Add Contact Details’ page as shown in the below screen.

1. : Add Contact Details Pop up

ii. Enter relevant information and click on save to save the record. iii. Click ‘Cancel’ to exit the page without saving the information.

Associate Documents

Click Associated Document tab where all attached documents are displayed, user will have provision to directly link the existing documents or add new documents to the respective devices.

1. : Associate Document Page

To add New Documents to Device, below are steps to follow:

1. Click on ‘Add Document’ button.
2. Select the files for uploading.
3. Enter the required information and click on save button.

1. : Add New Document Details Page

To link existing documents to device, below are the steps to follow:

1. Click on ‘Link Existing Documents’ button.
2. Select/check mark the files and click on Attach button.

1. : Link Existing Document To Device
2. Select the document and click on Attach. The document will be added to the list of documents in the page.
3. Click Edit button to edit the Document Properties.
4. Click button to delete the document from the listing.

Documents

During the Product Registration or change management, Life Science Organizations need to submit several documents such as reports, test results, regulatory documents as part of dossier to the regulatory authorities. Tracking of all the different kind of documents can be maintained in the Documents Module.

1. A list of all uploaded document records.
2. Buttons to Add, Manage, View, Disable, Audit a Document record.

1. : Documents Homepage

Add Document

1. Click the ‘+Document’ icon in Document Homepage. 2. Upload Documents’ Dialog box will open as shown in image.

1. : Upload Documents – Add Documents

3. The first page in the wizard allows user to select the files user want to upload. You can Select one or more files to upload.

• 1. Click ‘Select files’, select the document user want to upload.
  2. Click ‘Select files’ again to select another document.
  3. Click ‘Upload files’

4. The documents can be uploaded from File share, DMS application or SharePoint. 5. If user click DMS, the page will be re-directed to the DMS application login page. Once the files are uploaded, the page will be directed to ‘Document Properties’ as shown in the image.

1. : Document Properties Screen

6. On the top user would see tab with document name, if user uploaded two documents user will see two tabs and so on. 7. Enter the relevant information for the relevant document and click Save. 8. The document will be added to the list of documents in the homepage. Note: Class and Type mapping are done in based on which above dropdowns will cascade.

Submissions

Products

The Product Submissions tab contains, Applications, Sequences, Dossiers, Registrations ,Interactions, commitments, obligations, Global Updates, Local Updates, xEVMPD and CPPs sub-tabs.

Applications

Application Module is used for the process of submitting a product with all relevant information and obtaining an approval from the concerned authority. Only the Initial Application activity are tracked in Applications. Clicking on Applications tab, user will be directed to the Applications homepage as shown in the below screen.

1. : Application Homepage

The following details will be displayed on the page:

1. A list of all created Application records with Application ID and Application Group ID.
2. Buttons to +Application, Manage, Assigned to and Disable.
3. ‘Audit’ for each record.
4. ‘Disabled Records’ checkbox.
5. Filter based on-
   1. Application Category: Marketing Authorization, Investigational
   2. Stage : Pre-Approval, Post-Approval

Add Country Applications User can create Applications for ‘Marketable and Investigational’ category by selecting Product(s), Countries selection and other details. In other details user can incorporate Formulation, Therapeutic Details, Packaging, Organization(s), Documents etc., which are added in products module. The Formulation etc., details will display based on the selected product. To create an Application, below are the steps to follow:

1. Click the icon in Application page.
2. ‘Create Application’ wizard will open as shown in the below screen.

1. : Create Country Application- Select Product Page
2. The first wizard ‘Select Product’ will be displayed.
3. Select Product Category as ‘Investigational’ or ’Marketable’.
4. Select Application Type as “Country”
5. When user selects Marketable option from Product Category then, all the Marketable Products will display.
6. When user selects Investigational option from Product Category then, all the Investigational Products will display.
7. User will be allowed to select single product or multiple products including inactive products. For including inactive products select ‘Include inactive’ option.
8. Select the products from the listing and click button.
9. The second wizard ‘Choose Countries’ will be displayed with ‘.Country Group and Country Section’

1. : Create Country Application – Choose Countries Page
2. Select the Country Group, Procedure Type, Application Category, Default Submission Format, Countries and Click or Finish button.
3. If user selects Finish button, the created application record will be available in Applications homepage for select product(s).
4. If button is selected, user will be redirected to third wizard of Create Application or click back button to go to first wizard.

1. : Create Country Application – Other Details Page
2. The third wizard ‘Other Details’ will be displayed. Here, the product details and other details specified in the earlier screen will be displayed.
3. User can see tab with product name, if user selects two products user will see two tabs and so on.
4. For each Product, the ‘Formulations, Therapeutic details, Packaging and Organization(s) tabs etc., related to the product will be displayed in tabs. The information in this wizard is pulled in from products module.
5. Select the relevant information to the application Formulations etc. and click on Save button to save the selection.
6. Click button to complete the create application process.

1. : Create Country Application – National Procedure Records
2. When user selects single Products and Country Group as EU then for ‘Centralized’ Procedure Type, one application will be created for (entire) EU.

1. : Create Country Application – Centralized Procedure Record
2. When user selects single Product, Country Group as EU and for ‘MRP/DCP’ Procedure Type, If one RMS country is selected and multiple CMS Countries are selected then for each country individual application will be created. The Individual application(s) will be grouped under one application with Group ID.

1. &
2. Create Country Application – MRP and DCP Records
3. When the application is created, the major version will be created as V1.0.

To view the created application(s), below are the steps to follow:

1. Go to applications listing.
2. Select stage as ‘Pre-Approval’, grid will refresh and display created ‘Marketable and Investigational’ application(s).

To view the registration approved application(s), below are the steps to follow:

1. Go to application grid
2. Select stage as ‘Post-Approval’, grid will refresh and display registered ‘Marketable’ applications.

Add Global Applications Global application facilitates multiple application and Procedures across Country Groups. To create a Global Application, user needs to select the Application Type as “Global” as shown below:

1. : Creating Global Application: Select Product page

Users need to select required product(s) and its category, click on “Next” for the following page.

1. : Creating Global Application: Choose Modules page

Here users need to Assign the modules and select the Target Completion Date. Then give the required comment and click on “Save and Finish” to create a Global Application. Application will be listed in the Application Grid as shown below also with the same Application number a folder will be created in “DMS” along with date stamp in dd-mm-yyyy format.

1. : Listing of Global Application & Success message for Folder creation In DMS

1. : Folder creation with the Application number in DMS

User can differentiate the country Application / Global Application as per their ID as Country Applications starts with APPGXXX (for group) , NA (for single ) & Global Application ID GLAPXXX

• Folder creation in DMS is available only for Global applications (GLAPXXX)
• In DMS Folder naming convention follows (GLAPXXX + dd-mm-yyyy) format

Manage Country Applications User can enter specific information for an Application record through Manage button. And also user can manage Application Group Details and Application Details by selecting Application Id record and Application Group Id record. To Manage an Application, below are the steps to follow:

1. Select a record in the Application homepage and click the ‘Manage’ button.
2. Application Details, ‘Basic Info’ tab will be displayed as the default screen.
3. The following tab will be displayed on the left of the screen if Application Group ID record is selected for Manage:
   1. Application Group Details
4. The following tabs will be displayed on the left of the screen if Application ID record is selected for Manage:
   1. Application Details
   2. Product(s) details
   3. View Sequences
   4. View Dossiers
   5. Local Updates
   6. Interactions
   7. Obligations
   8. Commitments

Application Group Details

1. Select the Application Group ID record and click Manage.
2. The Basic Info details will display with Countries Detail section.
3. Enter the relevant information and click ‘Save’ button to save the record.
4. An option to add more CMS countries and Waves.

1. : Manage Country Application– Application Group Details Page.

Application Details

Basic Info:

1. Select the Application ID record and click Manage.
2. The Basic Info details will display.
3. Enter the relevant information and click ‘Save’ button to save the record.

1. : Manage Country Application–Basic Info Page

Local Plan tab: Local Plan helps the user assigning the modules to authorized users with target completion date.

1. : Manage Country Application–Local Plan Page

Select a Module go to Actions >>>> Edit, the below screen appears:

1. : Manage Country Application–Local Plan -Edit Page

Select Assign to and give the required submission dates with Lead time (if any). Click on Save and the update details will be reflected on the Local Plan Page as shown in Figure -96. Status tab:

1. Select ‘Status’ tab
2. Page will display status listing.

1. : Manage Country Application– Add Status Listing Page
2. Click button, the form will display as shown below.

1. : Manage Country Application– Add Status Page
2. Enter the Status information and click ‘Save’ button to save the record.
3. Click ,enter name and click on Save.

1. : Manage Country Applications- Save as Template Popup
2. The template will save in ‘Admin setting>>Setting>> Milestones’ and the added status details will display in Basic, Criteria and Milestones tabs (Admin setting>>Setting>> Milestones>>select created record>> click Manage).
3. Click button
4. The Milestone Templates popup will appear.
5. Based on the Application type in Basic Info tab, the Miles stone template details will display.
6. Select the template, view details and click ‘Save to Applications status’ button.
7. An alert message will display as ’ Are you sure you want to Override current Status(s) with selected Milestone Template Milestones?’.
8. When Ok button is clicked, the existing status will override with selected template status for the change.

1. : Manage Country Application –Milestone Template Popup
2. Click edit button to edit the status.
3. Click Disable button to disable the status.
4. Click Cancel to cancel the information without saving.

Responsible Person Tab:

1. : Manage Country Applications – Responsible Person Page

User can have the Responsible person information in this page as shown above in Figure -102. Click on to add the details shown in the below figure .

1. : Manage Country Applications – Responsible Person Page – Add Button

Product(s) Details

User can view the selected Product Details in Manage Application.

1. The Formulations tab will display by default as shown below.

1. : Manage Country Application– Product(S) Details Page.
2. Expand Toggle menu and click on the Manage Paracetamol to view respective tabs.
3. Formulations
4. Protocol – (The protocol link will display only for Investigational Product category records.)
5. Therapeutic Details
6. Packaging
7. Organization(s)
8. Associated Documents
9. Click Edit button, user will see a screen similar as shown below.

1. : Manage Application– Edit Registration Page
2. Select/Deselect the checkboxes to edit the information.
3. Expand the Formulations, click a value in the right, user will see associated information in the left. This will let user view the information before adding or remove it.
4. Therapeutic details, Packaging and Organization(s)/ Manufacturing sites is designed in a similar sequence.
5. Click Save to save the information.
6. Click Finish button and Ok button to add the record to Formulations table.
7. Similarly, the data can be added to other tabs Protocol, Therapeutic Details, Packaging etc.,
8. The Therapeutic Details, Packaging, Organization(s) etc., toggle menu tabs has a similar format to Formulations tab for data entry. Select the tabs, enter and Save the data.

View Sequences

User can View Sequences details in Manage Application if sequence(s) is created for that particular application.

1. Click ‘View Sequences’ tab

1. : Manage Application – Application View Sequences Page
2. The Sequence details will be displayed in by default.
3. Click on 0000, 0001 etc., sequence numbers to view the Sequence Details.
4. Click on button to view the sequence details in table.
5. Click ‘Create Sequence’ button, the page will be redirected to ‘Add Sequence’ page to create a new sequence.

View Dossiers

User can View Dossiers details in Manage Application if Dossier(s) is created for that particular application.

1. Click View Dossiers tab.

1. : Manage Country Application – Application View Dossiers Page
2. The Dossier details will be displayed in Tree view.
3. Click expand button to expand the tree view.
4. Click Sequence number 0000 etc., to view Sequence details.
5. Click Submission Packages – Central to view ‘Central Submission Packages’ details.
6. Click Submission Packages – Central to view ‘Upload Submitted Dossier’ details.
7. Click on document to view Package Details.

Local Updates

User can view Local updates specific to the Application in this Local Updates tab as shown in the below screen.

1. Country Applications-Local Update Page

The Local Updates tab will display following main grid in the page. Upon clicking on Local Update and Manage button, the page will be redirected to the Local Updates which contains “Basic Information, Changes, Impact Assessment, Documents, Submission Status and Registration Update” details of that particular Product

1. Country Applications-Local Update Manage Page

To understand the Local update more – refer Local Update section >> 8.1.9

Interactions

All the Queries related to different Health Authorities and Agencies can be managed here. To add the Application associated interactions click Interactions under Applications module as shown in below figure

1. Country Applications-Interactions Page

User will be navigated to Interaction’s home page

1. Country Applications-Interactions Grid

Interactions Home page options are + Interaction, Manage and Actions (refer to general functions section) To add an Interaction, refer to Interactions section – 8.1.5, except that the filters will auto-populate based on selected Application record.

1. Country Applications-Add Interactions Page

To add Tasks & Sub Tasks Refer section 8.1.5

Obligations

Once a Product is authorized, specific obligations are required to maintain the Marketing Authorization (MA). E.g. Annual Report, PSUR, Renewals. These Obligations based on country Law/Rules e.g. Regulation (EC) No 726/2004 in the EU. These Obligations are Implicit actions and must be carried out in the timeframe specified. To add the Application associated Obligations click Obligations under Applications module as shown in below figure:

1. Country Applications-Obligations Page

User will be navigated to Obligation’s home page. Obligations Home page options are Disabled Records, + Obligation, Manage and Actions (refer to general functions section) To add an Obligation, refer to Obligations section – 8.1.7, except that the filters will auto-populate based on selected Application record. Country Applications-Obligations Page

1. Country Applications-Add Obligations Page

To add Tasks & Sub Tasks, Refer Task in Obligations sections – 8.1.7

Commitments

Commitments are agreed to by a company with the health authority and are used to gather additional information about a medicine’s safety, efficacy, or optimal use. Commitments can be required either before or after the health authority has granted approval to a company to market a medicine and are explicit actions to maintain Marketing Authorization. To add the Application associated Commitments click Commitments under Applications module as shown in below figure:

1. Country Applications-Commitments Page

To add Commitments, refer Commitments section – 8.1.6, except that the filters will auto-populate based on selected Application record.

1. Country Applications-Add Commitments Page

To add Tasks, refer Task in Commitments sections >> 8.1.6 To add Sub Tasks, refer Sub Task in Commitment section >> 8.1.6 Manage Global Applications To manage a Global application, select the created Global Application record and click on .

1. : Manage Global Application – Selecting GLAP from Grid

Upon clicking Manage, Application will re-direct user to Basic Information page by default.

Global Application Details:

Basic Information Tab: In Basic Information tab, user can view application category and selected Product details in read only.

1. : Manage Global Application – Basic Information & Global Plan

Select module 1 and click on edit from Actions. User can Edit the Global plan details as mentioned below and click save (module 1 to module 5).

• Selected assign to
• Plan Start Date
• Actual Start Date
• Lead Time
• Target Completion date
• Actual Completed Date

1. :Global Plan edit screen

Countries Tab: In Countries tab user can add the required Countries and Procedure types for Global Application. User can assign each country application to a particular person.

1. : Manage Global Application – Countries Grid

Click on to add the Countries and select procedure type as shown in the below figure: Centralized, Decentralized and Mutual Recognition Procedure are enabled only for EU Country Group.

1. : Manage Global Application – Countries Tab

After selecting one or multiple procedure types, click on each procedure type to enter the below details and click on save:

• Default Submission Format
• Select Country Group
• Target Submission Date
• Assign To

1. : Adding Countries per procedure

After saving details for selected procedures, the country details will be available in the countries tab grid described in below Figure. In Countries tab, select the required records and click on as shown in below Figure:

1. : Manage Global Applications: Create Country Applications

All the country Application will be created in the Application Main Grid and the status of the Records in the above figure will change from “Not Created” to “Created”. All the Distributed Country Application will have same Global Application ID / Group ID and also will have a different Application ID as shown in the below figure:

1. : Manage Global Applications: Country Applications Listed in Grid

After Creating / Distributing Country Application: As shown in the above figure, expand the global application and click on any of the country application and user can manage those applications Individually by clicking on Manage button. Note: Change Waves/ + CMS (Applicable for Global EU Application

• To add a wave/ view it, select the global application and click on manage
• Countries Details grid will be displayed in Basic Info page
• Click on + Add CMS to add new CMS countries and save it.

Basic Info Tab: User can have the required Product and Application details in read only. Give the required information such as:

• Application Type
• Application number
• PSUR Code
• Inactive (if required)
• Procedure Number
• Application Name
• Application Owner
• Current Status
• Comments.

Enter the data and click on Save.

1. : Manage Global Distributed Application – Basic Info Page

Global Plan Tab: User can have Global Plan which has been created while creating global application as shown in figure in Read only with respective product name and application category.

1. : Manage Global Distributed Applications – Global Plan page

Local Plan Tab: User can assign or align their local plans as per global plan by clicking on Edit under action button. User can Edit the local plan details and click save (module 1 to module 5).

1. : Manage Global Distributed Application – Local Plan Page

Status Tab: Refer section 8.1.1.3.2. Application Details >>>> Status tab Responsible Person Tab:

1. Manage Global Distributed Application – Responsible Person Page

To add the responsible person, click on . Enter the data and click on save, the user will be reflected in Responsible Person grid. Convert to MRP User can convert an existing National approved Marketing Authorization application to MRP application using this feature. In Application Home page, user needs to filter post approval in Stage and select an EU National Application. . Click on Actions tab shown in the below figure and select Convert to MRP button.

1. : Convert to MRP button

Upon clicking a popup will appear to select CMS countries. The existing National country will be converted as RMS country.

1. : Select CMS countries pop up

Users need to select the required CMS countries and click on save button. A New MRP application will be created and listed with selected RMS and CMS countries as shown below.

1. : Converted MRP application listed in the grid

Sequences

User can filter Applications based on Application Category ‘Marketable / Investigational’ and Pre-approval/ Post- approval in the sequence listing and can create, manage Sequences for an Application. Clicking on Sequences tab, user will be directed to the Sequences homepage as shown in the below screen.

1. : Sequences Homepage

The following details will be displayed on the Sequences home page:

1. A list of all Application records
2. Expand application to view list of Sequence records with Sequence ID.
3. Options to +Sequence, Manage
4. Disabled Records’ checkbox, My favorites, View and Actions – Refer General functions section
5. ‘.Filter based on-
6. Application Category: Marketing Authorization, Investigational
7. Stage: Pre-Approval, Post-Approval
8. Sequence Type: Commitments, Interaction, Local Update, Obligation and Registration/ Application

Add Sequences User can add Sequence for an Application. Below are the steps to add a sequence.

1. Select the Application record from Pre-approval or Post-approval listing and click the icon in Sequence Homepage.
2. ‘Add Sequence’ page will open as shown below figure.
3. Enter all the required information, select ‘Request Dossier from Central Team’ as ‘Yes’ and click Save button

1. : Create Sequence – Add Sequence Page
2. Page will be redirected to ‘Request Dossier’ form as shown below.

1. : Create Sequence -Request Dossier Page

5. User can enter/view comments, attach files in Create Sequence right side pane for communication.6. Enter the required data and Click on button, Sequence and dossier will be created in grid under selected application in sequence and dossier home page respectively with a new sequence ID. When user clicks ‘Request Dossier from Central Team?’ as ‘No’ and click Save button, then only sequence(s) will be created in grid under selected application. Manage Sequences User can enter specific information for a Sequence record through button.

1. NOTE: User can add sequence details (Planning details, approval details and sequence documents once the dossier details (under dossier sub-module) are updated)

To Manage a sequence, below are the steps to follow:

1. Select a Sequence record in the Sequence homepage and click on ‘Manage’ button.
2. The ‘Sequence Details’ will display in Tree view in the left side pane.
3. As shown in below Figure, click on Sequence number 000X under Application number to view ‘Planning Details’.
4. Enter the data and save in ‘Planning Details’ tab

1. : Manage Sequence – Sequence Planning Details Page
2. Enter details in Approval Details tab as shown in the Figure, the Application Approved Details section will display only when HA Decision is selected as ‘Approved’

1. : Manage Sequence – Sequence Approval Details Page
2. Add the required details and click on Save.
3. User can see below mentioned buttons after saving the Approval details (Applicable only for marketable applications).

1. :Approved options
2. Click ,page will redirect to registration page to enter registration details if any.

Manage Sequences with submit pro integration User can enter specific information for a Sequence record through button.

1. : Sequence selection & manage button

NOTE: User can add sequence details (Planning details, approval details and sequence documents once the dossier details (under dossier sub-module) are updated) To Manage a sequence, below are the steps to follow:

1. Select a Sequence record in the Sequence homepage and click on ‘Manage’ button.
2. The ‘Sequence Details’ will display in Tree view in the left side pane.
3. As shown in below Figure, click on Sequence number 000X under Application number to view ‘Planning Details’.
4. Enter the data and save in ‘Planning Details’ tab

1. : Manage Sequence – Sequence Planning Details Page
2. Click on “Compile sequence” to push the sequence to “Submit Pro”.

NOTE: Application Number and Indication is required to perform Compile Sequence.

1. System will show the following success message

1. Fig : Compiling a sequence
2. Find the recently compiled sequence in “Submissions” section as shown below

1. Figure :Compiled Sequence is Submit pro
2. Enter details in Approval Details tab as shown in the Figure, the Application Approved Details section will display only when HA Decision is selected as ‘Approved’

1. : Manage Sequence – Sequence Approval Details Page
2. Add the required details and click on Save.
3. User can see below mentioned buttons after saving the Approval details (Applicable only for marketable applications).

1. :Approved options
2. Click ,page will redirect to registration page to enter registration details if any.

Dossiers

A ‘Dossier’ is a collection of documents with all the relevant information of a product to be submitted to health care authorities. The health care authorities usually specify different ‘folder structures’ of dossiers for submission. Clicking on Dossiers tab, user will be directed to the Dossiers homepage as shown in the below figure.

1. : Manage Dossier Homepage

The following details will be displayed on the dossier home page:

1. A list of all Application records with an option to expand, list of Sequence records with Sequence ID will display.
2. Dossier home page options are my favorites, view, manage and Actions (refer to general functions section).
3. .’
4. Filter based on-
5. Application Category: Marketing Authorization, Investigational
6. Stage : Pre-Approval, Post-Approval
7. Sequence Type: Commitments, Interactions, Obligation, Local Update, Registration/ Application

Manage Dossiers All the created sequences will display in the Dossiers module. User can enter specific information for a Sequence record through Manage button in Dossiers. To Manage a Dossiers, below are the steps to follow:

1. Select a Sequence record in the Dossiers homepage and click the ‘Manage’ button.
2. The ‘Product Details’ will display in Tree view in the left side pane and ‘Sequence Planning Details’ heading will display in right side pane.

1. : Manage Dossiers – Planning Details Page
2. Click on sequence number 000x, 000x etc., ‘Planning details; will display as shown in the figure.

1. : Manage Dossiers – Planning Details Page
2. Click on ‘Submission Packages – Central’ in tree view below a sequence number then ‘Central Submission Packages’ details will display as shown in the Figure.
3. When user selects “Can Support” as yes then, the Dossier request will be Assigned to another his/her team member.
4. Enter the relevant information and click on Submit.

1. : Manage Dossiers – Central Submission Packages Page
2. Click on ‘Submitted Dossiers – Local’ in tree view below a Submission Packages – Central then ‘Submitted Dossiers – Local’ details will display as shown in below figure.

1. : Manage Dossiers – Local Submission Packages Page
2. When user selects ‘Additional Docs Request’ as yes, the description field will be displayed to enter data and click Notify button.
3. When user selects ‘Additional Docs Request’ is no, user will be able to enter ‘Upload Submitted Dossier’ details.
4. When user click on button, the dossier will be saved.

NOTE: While creating a sequence, If the user has marked as yes in “Request Dossier from Central Team”, so after dossier is uploaded, user have to update the Approval Details in sequence.

Registrations

The Registration module allows you to track and maintain country-specific information of each Product. Registration details include both Product and Devices information. Clicking on Products module under Submissions Tab user will be directed to the Registrations homepage as shown in the below screen.

1. : Registration Homepage

The following information will display on the page:

1. A list of all the Registrations that have been added.
2. Buttons: + Registration, Manage, View, Assigned to and Disable.
3. ‘Audit’ for each record.
4. ‘Disabled Records’ checkbox.

Add Registration The Registrations can be created for ‘Marketable’ category by selecting Product(s), Countries selection and other details. In other details user can incorporate Formulation, Therapeutic Details, Packaging, Organization(s), Documents etc., which are added in products module. The Formulation etc., details will display based on the selected product. To add a Registration, below are the steps to follow:

1. Click icon in Registration Homepage.
2. ‘Create Registration’ wizard will open as shown in the below screen.

1. : Create Registration All Products Page
2. The first wizard ‘Select Product’ will be displayed.
3. Select Product Category as Marketable, all the Marketable Products will display.
4. User will be allowed to select single product or multiple products including inactive products. For including inactive products select ‘Include inactive’ option.
5. Select the products from the listing and click button.
6. The second wizard ‘Choose Countries’ will be displayed.

1. : Create Registration Choose Countries Page
2. Select the Country Group, Procedure Type, Countries and Click or Finish button.
3. If user selects Finish button, the created record will be displayed in Registration listing.
4. If button is selected then user will be redirected to third wizard of Create Registration or click back button to go to first wizard.

1. : Create Registration – Details to Register Page
2. The third wizard ‘Details to Register’ will be displayed. Here, the product details and other details specified in the earlier screen will be displayed.
3. User can see tab with product name, if user selects two products user will see two tabs and so on.
4. For each Product, the ‘Formulations, Therapeutic details, Packaging and Organization(s) tabs etc., related to the product will be displayed in tabs. The information in this wizard is pulled in from products module.
5. Select the relevant information to the registration Formulations etc. and click on Save button to save the selection.
6. Click button to complete the Create Registration process.

Creating registrations with different procedure types: Following are the steps for creating registrations with different procedure types by selecting Country Group and countries. To create National Procedure Registration:

1. Click +Registration
2. Select a Product from first wizard and click next
3. Select any Country Group
4. Select Procedure Type as National
5. Select multiple countries from second wizard as shown below:

1. : Multiple Countries Selection
2. Click Finish button in second wizard or user can add Formulations etc. and click Finish button in third wizard as per the requirement.
3. If two countries are selected, user will see two registrations in the listing and so on.
4. The created Registration records will display in the Registrations listing as shown below.

1. : Create Registration – National Procedure Records

To create Centralized Procedure Registration:

1. Click +Registration
2. Select a Product from first wizard and click next
3. Select Country group as EU
4. Select Procedure Type as Centralized’ from second wizard as shown below:

1. : Centralized country Group Selection
2. Click Finish button in second wizard or user can add Formulations etc. and click Finish button in third wizard as per the requirement.
3. The EU(Centralized) main record will be created and all EU countries will be created as sub records. The created Registration records will display in the Registrations listing as shown below.

1. : Create Registration – Centralized Procedure Records

To create Decentralized Procedure Registration:

1. Click +Registration
2. Select a Product from first wizard and click next
3. Select Country Group as EU
4. Select Procedure Type as Decentralized
5. Select one RMS and two CMS countries from second wizard as shown below:

1. : Decentralized country selection
2. Click Finish button in second wizard or user can add Formulations etc. and click Finish button in third wizard as per the requirement.
3. One RMS country will be created as main record and below multiple CMS country records will be created as sub records in the Registrations listing as shown below.

1. : Create Registration – Decentralized Procedure Records

To create Mutual Recognition Procedure Registration:

1. Click +Registration
2. Select a Product from first wizard and click next
3. Select Country Group as EU
4. Select Procedure Type as Mutual Recognition
5. Select one RMS Country ‘ and Select two CMS Countries from second wizard as shown below:

1. : MRP Country Selection
2. Click Finish button in second wizard or user can add Formulations etc. and click Finish button in third wizard as per the requirement.
3. One RMS country will be created as main record and below multiple CMS country records will be created as sub records in the Registrations listing.

1. : Create Registration – Mutual Recognition Records

To create GCC Procedure Registration 1. Click +Registration 2. Select a Product from first wizard and click next 3. Select Country Group as GCC 4. Select Procedure Type as national or GCC centralized 5. Select one LMS Country based on which other MS countries get selected as shown below for “GCC centralized” Procedure.

1. LMS and MS country selection

Note: as shown in figure 238 – Selected LMS country will be disabled automatically in MS country list 6. Select a country from the available country list for “national” procedure same as other procedures. Manage Registration User can enter specific information for a Registration record through Manage button. To Manage a registration, below are the steps to follow:

1. Select a record in the Registration homepage and click the ‘Manage’ button.
2. Primary tab will be displayed as the default screen.
3. The following tabs will be displayed on the left of the screen:
   1. Primary
   2. Secondary
   3. Trademark
   4. Formulations
   5. Therapeutic Details
   6. Packaging
   7. Organization(s)
   8. Documents
   9. Obligations
   10. Commitments
   11. Local Updates

1. : Manage Registration – Primary Page

Primary & Secondary

1. In the Primary tab, multiple tabs on the top of the page will display, the first tab is Product info, enter the details and click Save.
2. Likewise, user can select ‘Route of Admin’ and other tabs and enter and Save the details.
3. The secondary tab has a similar format to primary tab for data entry. Select the tabs in Secondary, enter and Save the data.

Note : Sunset clause check box is only available for EU Country group Registrations as shown in below figure-237. Based on “Date of First Authorization”, “Sunset Clause Date” will get calculated automatically. But system will restrict user to enter a date prior to “Sunset clause date” by disabling the dates.

1. Sunset clause rule

At any point of time, user can use the Reset button to clear any recent unsaved changes. Status tab:

1. select ‘Status’ tab
2. Page will display status listing.

1. : Manage Registration– Add Status Listing Page
2. Click button, the form will display as shown below.

1. : Manage Registration– Add Status Page
2. Enter the Status information and click ‘Save’ button to save the record.

Note : When User selects activity “Approved” or “Renewal approved” and save the milestone with an actual date a major version increment happens on that registration record . Example it gets up versioned from 0.1 to 1.0 or 1.0 to 2.0.

1. Click ,enter name and click on Save.

1. : Registrations- Save As Template Popup
2. The template will save in ‘Admin setting>>Setting>> Milestones’ and the added status details will display in Basic, Criteria and Milestones tabs (Admin setting>>Setting>> Milestones>>select created record>> click Manage).
3. Click button
4. The Milestone Templates popup will appear.
5. Select the template, view details and click ‘Save to Primary status’ button.
6. An alert message will display as ’ Are you sure you want to override current Status(s) with selected Milestone Template Milestones?’.
7. When Ok button is clicked, the existing status will override with selected template status for the change.
8. If Status is not added in the Status tab, then upon clicking on override ok button, selected template status will be added to the listing

1. : Manage Registration –Milestone Template Popup
2. Click edit button to edit the status.
3. Click Disable button to Disable the status.
4. Click Cancel to cancel the information without saving.

Trademark

In the Trademark tab, user can Add, Edit and Disable the data.

1. Select the + Trademark, enter the fields and Save button.

1. : Manage Registration – Trademark

Formulation, Therapeutic details, Packaging and Organization(s)

Formulation, Therapeutic details, Packaging and Organization(s) for a registration in the manage registration page will populate saved details automatically. Below Figure will provide an overview of the Formulations tab.

1. : Manage Registration Formulations Page

If user skipped adding this information during registration creation, user can use ‘Edit’ button provided for each of these tabs to add the information.

• • • 1. Click Toggle menu to enter Formulation and other product details for all the products in the registration.
      2. Click Edit button, user will see a screen similar as shown below.

1. : Edit Registration Page
   • • 1. Select/Deselect the checkboxes to edit the information.
       2. Expand the Formulations, click a value in the right, user will see associated information in the left. This will let user view the information before adding or remove it.
       3. Therapeutic details, Packaging and Organization(s)/ Manufacturing sites is designed in a similar sequence.
       4. Click Save to save the information.
       5. Click Finish button and Ok button to add the record to Formulations table.

Devices

Click Device tab to view a list of devices associated with the product as shown below.

1. : Registration Devices Tab
2. Click Edit, page will be redirected to Edit registration page.

1. : Registration Edit Devices Tab
2. Select/Deselect the checkboxes to edit the information.
3. Click Save to save the information.
4. Click Finish button and Ok button to add the record to the table.

Documents

Click Documents tab to view a list of documents associated with the product as shown below.

1. : Registration Documents Tab
2. Click Edit, page will be redirected to Edit registration page.

1. : Registration Edit Documents Tab
2. Fill up the above required fields.

Note : xEVMPD check box will be available only when the registration belongs to “EU” Country Group for the following file types:- [.PDF,.Doc, .Docx] .Checking the same will allow the document to be included in the xEVMPD XML .

1. Based on the requirement check xEVMPD and IDMP Checkbox
2. Click Save to save the information.
3. Click Finish button and Ok button to add the record to the table.

Interactions

Interaction Module has been divided into following sub modules depending on the query types. All the Queries related to different Health Authorities and Agencies can be managed here.

1. : Interaction Grid

To create an Application, below are the steps to follow:

1. Click + interactions
2. The page will display as shown below
3. Add the information and select a user from ‘Assign Users’ to assign the record to a particular user.
4. Click on save to add the Interactions.
5. The new record will be created in the listing/grid view.
6. The assigned user can login and update the interactions record.

1. : Add Interactions Page

To add Tasks, below are the steps to follow:

1. Click the ‘+ Task’ button.
2. ‘Add Interaction Task’ page will open.
3. Enter the relevant information and click ‘Save’ button to save the record.
4. The Business administrator user or assigned user can login and update status for the task.

1. : Registration Add Interaction Task

To add Sub Tasks, below are the steps to follow:

1. Click the ‘+ Subtask’ button.
2. ‘Add ‘Interaction Subtask’ page will open.
3. Enter the relevant information and click ‘Save’ button to save the record.
4. The Business administrator user or assigned user can login and update status for the sub- task.

1. : Registration Add Interaction Sub Tasks
2. To edit interaction, Task or Sub task, select the radio button, click button.
3. To Disable interaction, Task or Sub task, select the radio button and click button.
4. Click Cancel to cancel the information without saving.

Obligations

Once a Product is authorized, specific obligations are required to maintain the Marketing Authorization (MA). E.g. Annual Report, PSUR, Renewals. These Obligations based on country Law/Rules e.g. Regulation (EC) No 726/2004 in the EU. These Obligations are Implicit actions and must be carried out in the timeframe specified. Click Obligations tab to see a list of Obligations and associated tasks and sub tasks as shown below.

1. : Registration Obligations Tab

To add Obligations, below are the steps to follow:

1. Click the ‘+ Obligation’ button.
2. ‘Add Obligation’ page will open.
3. Enter the relevant information and click Assign To dropdown to assign to a user/team,
4. Click ‘Save’ button to save the record.
5. The Business administrator user or assigned user can login view and edit details.

1. : Registration Add Obligation

To add Tasks, below are the steps to follow:

1. Click the ‘+ Task’ button.
2. ‘Add Obligation Task’ page will open.
3. Enter the relevant information and click ‘Save’ button to save the record.
4. The Business administrator user or assigned user can login and update status for the task.

1. : Registration Add Obligations Task

To add Sub Tasks, below are the steps to follow:

1. Click the ‘+ Subtask’ button.
2. ‘Add ‘Obligation Subtask’ page will open.
3. Enter the relevant information and click ‘Save’ button to save the record.
4. The Business administrator user or assigned user can login and update status for the sub- task.

1. : Registration Add Obligations Sub Tasks
2. To edit Obligation, Task or Sub task, select the radio button, click button.
3. To Disable Obligation, Task or Sub task, select the radio button and click button.
4. Click Cancel to cancel the information without saving.

Commitments

Commitments are agreed to by a company with the health authority and are used to gather additional information about a medicine’s safety, efficacy, or optimal use. Commitments can be required either before or after the health authority has granted approval to a company to market a medicine and are explicit actions to maintain Marketing Authorization. Click Commitments tab to see a list of Commitments and associated tasks and sub tasks as shown below.

1. : Registration Commitments Tab

To add Commitments, below are the steps to follow:

1. Click the ‘+ Commitment’ button.
2. ‘Add Commitment’ page will open.
3. Enter the relevant information and click Assign To dropdown to assign to a user/team,
4. Click ‘Save’ button to save the record.
5. The Business administrator user or assigned user can login view and edit details.

1. : Registration Add Commitment

To add Tasks, below are the steps to follow:

1. Click the ‘+ Task’ button.
2. ‘Add Commitment Task’ page will open.
3. Enter the relevant information and click ‘Save’ button to save the record.
4. The Business administrator user or assigned user can login and update status for the task.

1. : Registration Add Commitments Task

To add Sub Tasks, below are the steps to follow:

1. Click the ‘+ Subtask’ button.
2. ‘Add ‘Commitment Subtask’ page will open.
3. Enter the relevant information and click ‘Save’ button to save the record.
4. The Business administrator user or assigned user can login and update status for the sub- task.

1. : Registration Add Commitments Sub Tasks
2. To edit Commitment, Task or Sub task, select the radio button, click button.
3. To Disable Commitment, Task or Sub task, select the radio button and click button.
4. Click Cancel to cancel the information without saving.

Local Updates

User can view Local updates specific to the registration in this Local Updates tab. The Local Updates tab will display following main grid in the page. Upon clicking on Local Update and Manage button, the page will be redirected to the Local Updates which contains “Basic Information, Changes, Impact Assessment, Documents, Submission Status and Registration Update” details of that particular Product.

1. : Registration -Local Updates

Convert to MRP To Convert a National Procedure Registration to MRP, Follow the below steps: 1. Select a Registration of National Procedure of EU. 2. Go to Actions >>>> Convert To MRP Convert to MRP feature is only applicable for EU Country Group. Incase user selects any Registrations with other Country Group and Procedures by default will be in disabled mode .

1. : Convert to MRP button

3. Existing National country will be the “RMS” country and system will ask user to select “CMS” countries.

1. : Select CMS Countries Pop up
2. Up on clicking “Save” , the Records will be created under the RMS country as shown below .

1. : Converted Registrations listed in the grid

Batch Update To add multiple Registrations to a Batch, Follow the below steps: Select the required Registrations , Click on Batch Update button as shown below .

1. : Batch Update Button
2. Add Batch Update Name & Comments, Click on Save.

1. : Batch Update Pop Up
2. A success Message will be displayed and system will re-direct you to Batch Update grid.

1. : Batch Update Grid

Interactions

The Interaction module helps you view and track the interactions between the different actors, in the application. An Interaction can happen between Regulatory Agency and a Pharmaceutical Company or a third-party agency. All the Interactions related to Registrations / Applications can be managed and monitored in this section.

1. : Interaction Grid

Add Interactions Interactions Home page options are Inactive records, + Interactions, manage, view and actions (refer to general functions section) To add an Interaction, follow the below steps:

• • 1. Click on for Navigating to “Add Interaction” page

1. The filters will auto-populate based on selected registration record.
2. Add/select the data in the below fields:

• Interaction Topic
• Communication Type
• Communication Mode
• Interaction Type
• Interaction Subtype
• Received Date
• Due Date
• Reference Number
• Assign To
• From Organization
• To Organization
• Status
• Inactive
• Description
• Comments
• Status Date

1. : Add Interactions Page
2. Click on Save. A New record will be populated in the Obligation Grid.

Manage Interactions User can enter specific information for a specific Interaction record through button, by following below steps. Select an Interaction record in the ‘Interactions’ homepage and click on ‘Manage’ button will display below tabs.

1. Obligation Details – Add the sequence details using ‘+ Sequence’.
2. Documents – refer to section 5.4.9 Products>> Associated Documents.
3. Status – refer to section Refer section 8.1.1.3.2. Application Details >>>> Status tab

1. : Manage Interactions Page

Add the required details and click on ‘Save’. Task and Sub Task

1. Select a record in the Interactions homepage.
2. Click the ‘+ Task’ Task’ button to add a task for an Interaction.

1. : Task In Interactions

3. Enter the relevant information in ‘Add Interactions Task’ page, and to assign the task, select user from ‘Assign To’ dropdown. Click on ‘Save’. 4. An email will be triggered to the assigned user.

1. : Interaction – Add Task page

Click on ‘+ Subtask’ button to add a subtask for an Interaction.

1. : Interaction Subtasks

5. Enter the relevant information in ‘Add Sub Task’ page, and to assign the subtask, select user from ‘Assign To’ dropdown. Click on save. 6. An email will be triggered to the assigned user.

1. : Interaction – Add Sub task page

Commitments

All the Commitments related to Registrations / Applications can be managed and monitored in this section.

1. : Commitments Home Page

Add Commitments Commitments Home page options are Inactive records, Disabled Records, + Commitment, Manage and Actions (refer to general functions section) To add a Commitment, follow the below steps: 1. Click on for Navigating to “Add Commitment” page 2. Select the required information from the filters 3. Add/select the data in the below fields:

• Commitment Name
• Commitment Type
• Commitment Subtype
• Commitment Due Date
• Scheduled
• PSUR Reportable Event
• Assigned To
• Status
• Description
• Inactive
• Application Number
• Status Date
• PSUR Code
• Comments

1. : Add Commitment Page

4. Click on Save. A New record will be populated in the commitment Grid. Manage Commitment User can enter specific information for a specific commitment record through button, by following below steps. Select a Commitment record in the ‘Commitments’ homepage and click on ‘Manage’ button will display below tabs. Commitment Details – Add the sequence details using ‘+ Sequence’. Documents – refer to section 5.4.9 Products>> Associated Documents. Status – refer to section Refer section 8.1.1.3.2. Application Details >>>> Status tab Add the required details and click on ‘Save’. Task and Sub Task

1. Select a record in the Commitment homepage.
2. Click on ‘+ Task’ button to add a task for a commitment.

1. : Commitment Task

3. Enter the relevant information in ‘Add Task’ page, and to assign the task, select user from ‘Assign To’ dropdown. Click on ‘Save’. 4. An email will be triggered to the assigned user.

1. : Commitment – Add Task page
2. Click on ‘+ Subtask’ button to add a subtask for a commitment.

1. : Commitment Subtasks

5. Enter the relevant information in ‘Add Sub Task’ page, and to assign the subtask, select user from ‘Assign To’ dropdown. Click on save. 6. An email will be triggered to the assigned user.

1. : Commitment – Add Sub task page

Obligations

All the Obligations related to Registrations / Applications can be managed and monitored in this section.

1. : Obligations Home Page

Add Obligations Obligations Home page options are Inactive records, Disabled Records, + Obligation, Manage and Actions (refer to general functions section) To add an Obligation, follow the below steps:

1. Click on for Navigating to “Add Obligation” page
2. Select the required information from the filters.
3. Add/select the data in the below fields:

• Obligation Name
• Obligation Type
• Obligation Subtype
• Obligation Due Date
• Recurrence
• PSUR Reportable Event
• Assign To
• Status
• Description
• Inactive
• Application Number
• Status Date
• PSUR Code
• Comments

1. : Add Obligation Page
2. Click on Save. A New record will be populated in the Obligation Grid.

Manage Obligation User can enter specific information for a specific Obligation record through button, by following below steps. Select an Obligation record in the ‘Obligations’ homepage and click on ‘Manage’ button will display below tabs. Obligation Details – Add the sequence details using ‘+ Sequence’. Documents – refer to section 5.4.9 Products>> Associated Documents. Status – Refer section 8.1.1.3.2. Application Details >>>> Status tab Add the required details and click on ‘Save’. Task and Sub Task

1. Select a record in the Obligation homepage.
2. Click on ‘+ Task’ button to add a task for an Obligation.

1. : Obligation Task

3. Enter the relevant information in ‘Add Obligation Task’ page, and to assign the task, select user from ‘Assign To’ dropdown. Click on ‘Save’. 4. An email will be triggered to the assigned user.

1. : Obligation – Add Task page

4. Click on ‘+ Subtask’ button to add a subtask for an Obligation.

1. : Obligation Subtasks

5. Enter the relevant information in ‘Add Sub Task’ page, and to assign the subtask, select user from ‘Assign To’ dropdown. Click on save. 6. An email will be triggered to the assigned user.

1. : Obligation – Add Sub task page

Global Updates

A Drug Life Cycle consists of multiple stages and these can be Initial Application, Variation Submissions, Annual Reports, Safety Reports, Renewals, and so on for a Product. Post-approval activities are tracked under Global and Local Update Modules. All these processes for products that have global applicability requires extensive global planning and tracking. Whenever a change is applicable globally/ Centrally, Global Update Module helps to define the Global change, perform impact assessment and distribute the change as individual Local Updates records.

1. : Global Update Homepage

The following details will be displayed on the page:

1. A list of all created Global Update records.
2. Buttons ‘+Global Update’, View, Manage and Actions for workflow.
3. ‘Disabled Records’ check box to view all the Disabled records in the grid.
4. Include Completed Records check box to view all the records along with completed records in the grid.
5. Include Archived Records check box to view all the records along with Archived records in the grid.
6. My Favorites, to view favorite records.
7. For Actions, ‘Assigned To’ options, refer section 13.
8. ‘Audit’ for each record.

Add Global Updates The Global updates can be created by selecting Registrations, Global update details and adding the change. To add a Global update, below are the steps to follow:

1. Click the ‘+Global Update’ icon in Global Updates Homepage.
2. ‘Create Global Update‘ wizard will open as shown below.
3. The first wizard ‘Registrations’ will be displayed.
4. Select filters for Active Ingredient, Product Family(s), product(s), Country Group9s) and Country(s) to view Registrations in the listing.

1. : Create Global Update – Select Registrations Page
2. Select the single or multiple registration(s) and click .
3. The second wizard ‘Update Details’ will be displayed.

1. : Create Global Update – Update Details Page
2. Enter/select the required information.
3. If button is selected, user will be redirected to third wizard or click back button to go to first wizard.
4. The third wizard ‘Changes’’ will be displayed when user clicks on “Save & Finish”.

1. : Create Global Update – Changes Page
2. Click ‘+Change’ to add the change for the global update.

1. : Create Global Update – Add Change

Enter the change information click on ‘Save’ button.

1. : Create Global Update – Add Change Grid
2. User can Add multiple changes as per the requirement.
3. Click ‘delete’ icon to delete the created changes.
4. Click button to add the Global Update to the listing.

Manage Global Updates User can enter specific information for a Global Update record through Manage button. To Manage Global Updates, below are the steps to follow:

1. Select a record in the Global Update homepage and click the ‘Manage’ button.
2. By default, user will see the following tabs on the screen:
   1. Basic Information
   2. Changes
   3. Impact Assessment
   4. Documents
   5. Distribution

Basic Information

The Basic information tab will be displayed in Manage Global Update as a default tab.

1. The Basic Information will have selected registrations from create global update page.
2. Enter/update the information and click save button to save the respective details.
3. ‘Archived’ checkbox, ‘Inactive’ checkbox, ‘Completed’ checkbox, ‘Grouping’ checkbox and ‘Work Sharing’ checkbox. These check boxes allows the user to mark the Global updates as Archived or Inactive or Completed. (Note: Grouping and work sharing are applicable to EU registrations)
4. Responsible person grid will allow the user to add a concern person for the update.

1. : Manage Global Update – Basic Information Page

Changes

The Changes tab will be displayed in Manage Global Update. The Changes tab will have created changes from create global update. User can ’+ Change’, Edit and Disable ‘Changes’ details as shown below.

1. : Manage Global Update – Changes Page
2. Click the ‘+Change’ icon in ‘Changes’ tab, the ‘Add Change’ popup will display.

1. : Create Global Update – Add Change Popup
2. Enter the relevant information for the ‘change’ and click ‘Save’ button.
3. Click ‘Cancel’ button, to close the popup without saving the data.
4. Upon clicking on save, the change details will be added to the grid.
5. Select the change record and click on ‘Disable’ button to remove the record from the list permanently.

Impact Assessment

The Impact Assessment details can be added in Manage Global Update. User can add impact assessment details for a change by clicking Impact Assessment tab.

1. : Manage Global Update – Impact Assessment Page
2. Click ‘+Impact Assessment’ button.
3. Impact assessment popup will display.
4. User can enter Impact assessment for Global’ or ‘Individual Country’.
5. Select ‘Global’ in ‘Add impact assessment’ popup.

1. : Manage Global Update – Add Global Impact Assessment Popup.
2. Enter the relevant information and click on’ save’.
3. Select ‘Individual Country’ in ‘Add impact assessment’ popup.

1. : Manage Global Update – Add Individual Country Impact Assessment Popup.
2. Enter comments, select impact assessment option registration and click on “Save’.
3. Upon save, the impact assessment details will be added to the change.

Documents

The Documents details can be added in Manage Global Update. You can link documents by clicking on tab.

1. Click on ‘+ Document’ to select files from ‘File Share’ or ‘Documentum’ and upload to Documents section.
2. Click on ‘+Link Existing Document’ button in Document tab.

1. : Manage Global Update – Link Existing Documents Page
2. The List with all documents will display in a page as shown in the image.

1. : Manage Global Update – Add Link Existing Documents Page
2. The page allows user to select the document to Attach. User can Select one or more files and click on ‘Attach’ Button or ‘Cancel’ to go back to previous page.
3. Once the documents are attached user will be redirected to document page.

1. : Manage Global Update – Link Existing Documents Page with Document

Distribution

The Distribution details can be added in Manage Global Update.

1. : Manage Global Update – Distribution Page.

To add Distribution details below are the steps to follow:

1. Click on ‘+Distribution’ button in Distribution’ tab.
2. Distribution set popup will display with registration details.

1. : Manage Global Update – Distribution Set Popup.
2. Enter Title, select Registration(s) and click on Save button or Distribute button.
3. If Save button is clicked, the record will be saved to the listing. The saved information will display in Manage, user can ‘Save’ or ‘Distribute’ from Manage.

1. : Manage Global Update – Distribution Tab With Saved Details.
2. If ‘Distribute’ button is clicked and ‘Ok’ button in alert message is clicked, the registration will be distributed with new ‘LU ID’, and status updated in main grid. The LU ID will also display in the Local update module.
3. Select the non-distributed record and click on ’+Distribution’, to perform distribution.

1. : Manage Global Update – Manage Distribution.
2. The saved information will display in Manage, user can ‘Save’ or ‘Distribute’ from Manage.
3. If save button is clicked, the record will be saved to the listing.
4. If ‘Distribute’ button is clicked and ‘Ok’ button in alert message is clicked, the registration will be distributed with new ‘LU ID’ and status updated in main grid. The LU ID will also display in the Local update module.

1. : Manage Global Update Listing With LU ID.
2. Select the distributed record and click on ‘Manage’, the registration will be grayed out as shown in below screen.

1. : Manage Global Update – Manage Distribution, Distributed Record.
2. After distribution the Over status button will be enabled
3. Click on ‘Overall Status’ button in ‘Actions”, the registration will display with unique Local update Id.

1. : Manage Global Update – Overall Status Popup.
2. Up on clicking on the ‘LU Id’, the page will be redirected to the Local Update Details tab and LU Id details will display in the Local updates Basic information tab.

Local Updates

Local Update Module helps to define country specific changes or modify the changes distributed from the Global Updates to meet the local requirements. Once the change submission set is finalized, user can assess the change impact on the relevant records and track the submission to authorities for approval. An LU is referred to as ‘Variation’ in European Union countries and referred as ‘Supplements’ in the United States countries. Clicking on Local Updates tab, user will be directed to the Local Updates homepage as shown in the below screen. The following details will be displayed on the page:

1. A list of all created Local Update records.
2. Buttons: Add, View, Manage and Actions.

‘

1. ‘‘Disabled Records’ check box to view all the Disabled records in the grid.
2. Include Completed Records’ check box to view all the records along with completed records in the grid.
3. ‘Include Archived Records’ check box to view all the records along with Archived records in the grid.

‘My Favorites’, to view favorite records.

1. : Local Update Homepage

Add Local Updates To add a ‘Local update’, below are the steps to follow:

1. User Click the ‘+Local Update’ icon in Local Updates Homepage.
2. ‘Create Local Update ‘wizard will open as shown below.
3. The first wizard ‘Applications/Registrations’ will be displayed.
4. Select Filters for Product Category, Product(s), Country Group(s) and Country, to view Registrations in the listing.

1. : Create Local Update – Select Applications/Registrations Page
2. Select the single or multiple registration(s) and click .
3. The second wizard ‘Update Details’ will be displayed.

1. : Create Local Update – Update Details Page
2. Enter/select the required information.
3. If button is selected, user will be redirected to third wizard or click back button to go to first wizard.
4. The third wizard ‘Changes’’ will be displayed as shown in below figure.

1. : Create Local Update – Changes Page
2. Click ‘+Changes’ to add the change for the Local update.

1. : Create Local Update – Add Change
2. Enter the ‘Changes’ information and click on ‘Save’ button.

1. : Create Local Update – Add Change Grid
2. User can Add multiple changes as per the requirement.
3. Click ‘Delete’ button to delete the added changes.
4. Click button to add the ‘Local Update’ to the listing.
5. When user selects single registration, update details and corresponding change while creating a Local update. Then upon clicking ‘Save &Finish’ button, one Local Update for each registration will be created.
6. When user selects multiple registration, update details and corresponding changes while creating a Local update. Then upon clicking ‘Save & Finish’ button, one Local Updates for multiple registration will be created.
7. When user select multiple registrations and click on ‘Create multiple Local Updates when Finished?’ option and update details, corresponding changes while creating a Local update, and upon clicking ‘Finish’ button, multiple Local Updates for each registration will be created.

Manage Local Updates User can enter specific information for a Local Update record through Manage button. To Manage Local Updates, below are the steps to follow:

1. Select a record in the Local Update homepage and click on ‘Manage’ button.
2. By default, user will see the following tabs on the screen:
3. Basic Information
4. Changes
5. Impact Assessment
6. Documents
7. Submission Status
8. Registration Update
9. User will be able to add/select the details for the first Basic information.

Basic Information tab:

The Basic information tab will be displayed in Manage Local Update as a default tab.

1. The Basic Information will have selected registrations from create Local update page.
2. Enter/update the information and click ‘Save’ button to save the respective details.
3. Responsible person grid helps user to track concerned responsible persons for Local Update.
4. Archived and Completed check box will allow users to mark the Local updates as Archived or Completed, as per the requirement.

Note: Checking the completed check box and saving the local update would trigger a minor version increment in the related registration record.

1. : Manage Local Update – Basic Information Page

Changes tab:

The ‘Changes’ tab will be displayed in Manage Local Update. The Changes tab will have created changes from create Local update. User can Add, Edit and Disable ‘Changes’ details as shown below.

1. : Manage Local Update – Changes Page

Click the ‘+Change’ icon in Changes tab.

1. : Create Local Update – Add Change Popup
2. Enter the relevant information for the change and click ‘Save’ button.
3. Click ‘Cancel’ button, to close the popup without saving the data.
4. Upon clicking on save, the change details will be added to the grid.
5. Select the ‘Change’ record and click on ‘Disable’ button to remove the record, and the record will be listed under ‘Disabled Records’.

Impact Assessment

The Impact Assessment details can be added in Manage Local Update. When user clicks a registration the change(s) will be displayed and for each change the impact assessment can be added.

1. : Manage Local Update – Impact Assessment Page
2. Click the Registration ID, all the added changes will display in the ‘Changes’ listing.
3. Select a change record from ‘Changes’ section.
4. Click ‘+’Impact Assessment’’ button.
5. Impact assessment popup will display.

1. : Manage Local Update –Add Impact Assessment Popup.
2. If ‘Submission not required’ option is selected, then ‘Is Registration Update Required’ option will appear in impact assessment popup.
3. Select ‘Impact Assessment’, enter “Comments’ and click on ‘Save’ button.
4. Upon save, the impact assessment details will be added to the change.
5. If Submission required or Approval required is selected, then user can create a Sequence.

To create a sequence for change below are the step to follow:

1. Select the ‘Submission required’ or ‘Approval required’ change and click on ‘+Create Sequence’ button.

1. : Manage Local Update –Create Sequence Button for A Change
2. The ‘Create Sequence’ popup will display.

1. : Manage Local Update –Create Sequence popup.
2. Enter mandatory data and click ‘Save’ button. the new sequence will be created in Sequence module.
3. If ‘Request Dossier from Central Team? Is ‘yes’, the Request Dossier popup will display.

1. : Manage Local Update –Request Dossier Popup.
2. Enter the details and click ‘Save & Notify’ button, the dossier will be created for the Sequence in Dossiers module.

Note : users have an option to edit already added impact assessment. But for an impact assessment if a sequence has already been created , users need to disable the sequence first to edit the impact assessment.

Documents

The Documents details can be added in Manage Local Update. You can link documents by clicking on tab.

1. Click on ‘+ Document’ to select files from ‘File Share’ or ‘Documentum’ and upload to Documents section.
2. Click on ‘+Link Existing Document’ button in Document tab.

1. : Manage Local Update – Link Existing Documents Page
2. The List with all documents will display in a page as shown in the image.

1. : Manage Local Update – Add Link Existing Documents Page
2. ‘The page allows user to select the document to Attach. User can Select one or more files and click on ‘Attach’ Button or ‘Cancel’ to go back to previous page.
3. Once the documents are attached user will be redirected to document page.

Submission Status

The Submission Status details will be added in Manage Local Update. user can select and enter details by clicking on tab. The Sequence created changes from Impact Assessment tab will display in Submission status ‘Changes’ section listing.

1. Click the Registration Record ID, all the added changes will display in the ‘Changes’ listing.
2. Select a change from ‘Changes’ section.
3. Enter ‘Comments’ in ’Submission Status’ tab.
4. Click ‘Save’ button to Save the details.

1. : Manage Local Update – Submission Status Page
2. Click the Status tab.
3. Click ‘+Status’ as shown below.

1. : Manage Local Update – Submission Status with Status Tab
2. The ‘Add Status’ popup will appear.
3. Enter all the information and click on ‘Save’ button.

1. : Manage Local Update – Submission Status Add Status Popup
2. Click ,enter ‘Milestone Template Name’ and click on ‘Save’.

1. : Manage Local Update – Submission Status Save As Template Popup
2. The template will save in ‘Admin setting>>Setting>> Milestones’ and the added status details will display in Basic, Criteria and Milestones tabs (Admin setting>>Setting>> Milestones>>select created record>> click Manage).
3. In ‘Actions’, Click button.
4. The Milestone Templates popup will appear.
5. Select the template, view details and click ‘Save to Local Updates Change status’ button.
6. An alert message will display as ‘Are you sure you want to add current Status(s) with selected Milestone Template Milestones?’’.
7. When Ok button is clicked, the existing status will be replaced with selected template status for the change.
8. If Status is not added in the Status tab, then upon clicking on override ok button, selected template status will be added to the listing.

1. : Manage Local Update–Submission Status Milestone Template Popup
2. Click ‘Edit’ button to edit the status.
3. Click ‘Disable’ button to disable the status.

Registration Update:

The Registration Update details will be added in Manage Local Update. User can select and enter details by clicking on tab. The Sequence created changes from Impact Assessment tab will display in Registration Update ‘Changes’ section listing.

1. : Manage Local Update – Registration Update Page
2. Click the Registration Record ID, all the added changes will display in the ‘Changes’ listing.
3. Select a change from Changes section.
4. Click ‘+Task’.

1. : Manage Local Update – Registration Update Page
2. Enter the relevant information and assign the task.
3. Click ‘Save’ button to Save the details.
4. Click ‘Edit’ button to edit the task.
5. Click ‘Disable’ button to disable the task.
6. An email will be triggered to the assigned user.
7. The ‘Assigned user’ can login and update the task. The details will be updated to the task.

xEVMPD

All medicinal products for human use authorized in the EU, and that marketing authorization holders shall, by 02-Jul-12 at the latest, electronically submit to the EMA information on all medicinal products for human use authorized or registered in the EU using the format defined by the EMA Clicking this Submission Module>>Products>> xEVMPD module will take user to the XEVMPD homepage where user will see the following: xEVMPD Submissions tab:

1. A list of all created XEVMPD submission records generated from the combination of following:
   1. No of Language at Submissions >>>>Products >>>>Registrations >>>>Manage >>>> Product Info >>>> Name Section
   2. No of Registration Pack details at Submissions >>>> Products >>>> Registrations >>>>Manage >>>> Packaging >>>> Registrations Pack details(optional)
2. Buttons: View, Manage, Operations (Insert X*, Update X*,Nullify X*,Invalidate X*) & Actions (Audit).
3. ’Search’ to search the ‘XEVMPD Submissions’ records.

1. : XEVMPD Submissions Tab

Submission Status tab: 1. Grid shows the status of the submissions with generated XML. 2. Actions button to show ‘View Basic Information’ & to ‘Upload Acknowledgment’ received from EMA.

1. : xEVMPD Submission Status Tab

Generate xEVMPD Submission XML

1. Select a generated xEVMPD record and click on operations >>>> Insert.
2. User will get the following message:

1. Same record will be transferred to “Submission Status Tab” as shown below:

1. : Select Registrations Page
2. Click on ‘View XML’ hyperlink.

1. : Downloaded XML file
2. A file will be downloaded as shown above.
3. Open the file to View the XML generated.

1. : Generated XML
2. . For the “Detailed XML” generation follow the step from 1 to 3.
3. : Detailed XML file
4. Then Click on “Detailed XML” hyperlink & a Zip file will be downloaded including all the required files

To View Basic Information To View Basic information of a Submission go to “Submission Status” tab select a submission record.

1. : View Basic Information Button

As shown in Figure -251, click on and the below pop up appears .

1. : View Basic Information Pop Up

Uploading Acknowledgments 1. To upload acknowledgments, go to the “Submission Status” & Click on the following:

1. :Upload Acknowledgments Button

1. : Upload Acknowledgment Pop Up

2. As shown in the above figure, select the acknowledgment type and upload the file by clicking on select Files . 3. Click on Save. 4. Date and file name will appear as shown in the below figure. 5. Similar way the steps can be used for uploading 2^nd & 3^rd Ack Received also .

1. : Ack Received date

CPPs

CPPS User can create CPP records details based on specific information in this section, clicking this Submission Module will take user to the CPP homepage where user will see the following:

1. A list of all created CPP records.
2. Buttons to Add, View, Manage, Received CPP, My Favorites, Audit.
3. ‘Disabled Records’ checkbox.

1. : CPP Homepage

Add CPPS

1. Click the ‘+ Create CPP Request’ icon in CPPS Homepage.
2. ‘Create CPP Request’ page will open as shown as in Figure.

1. : Create CPP Request Page
2. Enter/select the CPP details for to create a CPP record.
3. Click on Submit button, an email notification will trigger to respective User(s).
4. Click ‘Cancel’ button to go to the previous screen.

Manage CPPS You can enter specific information for a CPP record through Manage button.

1. Select a CPP record in the homepage and click the ‘Manage’ button.
2. The ‘CPP Request Details’ page will display.

1. : Manage CPP – CPP Request Details
2. Upon Accept, user can assign the task to Associate or his/her Team member by entering ‘Planned Submission Date’.
3. After acceptance and user assign an email will be triggered to concerned CPP users.
4. User/associate can provide “Product Approval Details” and update “CPP Application Status Details”.

1. : Manage CPP – CPP Request Details Assign To Central Page

The following ‘CPP Application Status Details’ fields will be displayed for Associate

1. Under Preparation
2. Application Submitted
3. HA Query
4. CPP Received from HA
5. CPP Sent for Legalization
6. CPP Sent to Requestor
7. User can enter ‘CPP Application Status Details’ in each tab and Save.
8. When Associate clicks Hold the CPP request will be in Hold
9. When Associate clicks Terminate the CPP request will be in Closed.
10. If ‘Apostilization / Legalization Needed’ No, then in Manage CPP, ‘CPP Sent for Legalization’ will not display for Associate.

Note: Email triggers are available for “CPP Application submitted “ , “CPP Dispatched” and “CPP received”. Edit CPP Application status Details The feature allows user to edit the details available in CPP Application status details . Edit option are available for the following :

1. Under Preparation
2. Application Submitted
3. HA Query
4. CPP Received from HA
5. CPP Sent for Legalization
6. CPP Sent to Requestor

1. : Edit option for CPP Application status details

Devices

Registrations

The Registration module allows user to track and maintain country-specific information of each Device. Registration details include Devices information. Clicking on ‘Device module’ under Submissions Tab user will be directed to the Registrations homepage as shown in the below screen.

1. : Device Registration Home page

The following information will display on the page:

1. A list of all the Registrations that have been added.
2. Buttons: + Registration, Manage, View and My favorites, Inactive Records and Disabled Records. Actions for workflow.

Add Registration The Registrations can be created for ‘Marketable’ category by selecting Product(s), Countries selection and other details. In other details user can select add Model, Therapeutic Details, Packaging, Organization(s), Documents., which are added in devices module. To add a Registration, below are the steps to follow:

• • • 1. Click icon in Registration Homepage.
      2. ‘Create Registration’ wizard will open as shown in the below figure.

1. : Create Registration All Devices Page

3. The first wizard ‘Select Device’ will be displayed. 4. Select ‘Device Category’ as Marketable, all the Marketable Devices will display. 5. User will be allowed to select single or multiple devices including inactive. 6. Select the devices from the listing and click button. 7. The second wizard ‘Choose Countries’ will be displayed.

1. : Create Registration Choose Countries Page

8. Select the Country Group, Countries, Procedure Type and Click or Finish button.

1. If user selects ‘Finish’ button, the created record will be displayed in Registration listing.
2. If button is selected then user will be redirected to third wizard ’Details to Register’ or click back button to go to first wizard.

1. : Create Registration – Details to Register Page
2. The third wizard ‘Details to Register’ will be displayed. Here, the device details and other details specified in the earlier screen will be displayed.
3. User can see tab with device name, if user selects two devices user will see two tabs and so on.
4. For each Device, the ‘Model, Therapeutic details, Packaging, Organization(s) and Documents tabs, related to the Device will be displayed in tabs. The information in this wizard is pulled in from device module.
5. Select the relevant information to the registration and click on ‘Save’ button to save the selection.
6. Click button to complete the ‘Create Registration’ process.

Creating registrations with different procedure types: Following are the steps for creating registrations with different procedure types by selecting Country Groups and countries. To create National Procedure Registration:

• • 1. Click ‘+Registration’
    2. Select a Product from first wizard and click ‘Save & Next’.
    3. Select any ‘Country Group’
    4. Select ‘Procedure Type’ as ‘National’.
    5. Select multiple countries from second wizard as shown below:

1. : Device Registration country group & country section
   • 1. Click ‘Finish’ button in second wizard or user can add device details and click ‘Finish’ button in third wizard as per the requirement.
     2. If two countries are selected, user will see two registrations in the listing and so on.
     3. The created Registration records will display in the Registrations listing as shown below.

1. : Create Registration – National Procedure Records

To create Centralized Procedure Registration:

• • • 1. Click ‘+Registration’
      2. Select a Product from first wizard and click ‘Save & Next’
      3. Select Country Group as EU
      4. Select Procedure Type as ‘Centralized’ from second wizard as shown below:

1. : Create Registration for centralized procedures
   • • 1. Click ‘Finish’ button in second wizard or user can add device details and click ‘Finish’ button in third wizard as per the requirement.
       2. The EU (Centralized) main record will be created, in the Registrations listing as shown below.

1. : Create Registration – Centralized Procedure Records

Manage Registration User can enter specific information for a Registration record through Manage button. To Manage a registration, below are the steps to follow:

1. Select a record in the Registration homepage and click the ‘Manage’ button.
2. Basic Information tab will be displayed as the default screen.
3. The following tabs will be displayed on the left of the screen:
   1. Basic Details
   2. Models
   3. Authorized Representative
   4. Therapeutic Details
   5. Packaging
   6. Organization(s)
   7. Documents

1. : Manage Registration Page

Basic info

Basic info details information for the device added at the time of adding registration record, will be shown in the read only format.

1. Select/add the Basic Info details.
2. Enter the relevant information and click ‘Save’ button to save the record.
3. ‘Reset’ button to reset the record and ‘Delete’ button to delete the record.

Application Details tab:

• • • 1. Select ‘Application Details’ Tab
      2. Page will display, enter relevant information in the respective fields.

1. Click on “save” button to save the record.
2. ‘Reset’ button to reset the record and ‘Delete’ button to delete the record.

1. : Application Details Tab

Status Tab:

1. select ‘Status’ tab.
2. Page will display status listing.

1. : Manage Registration– Add Status Listing Page
2. Click button, the form will display as shown below.

1. : Manage Registration– Add Status Page
2. Enter the Status information and click ‘Save’ button to save the record.
3. Click ,enter ‘Milestone Name’ and click on ‘Save’.

1. : Registrations- Save As Template Popup
2. The template will save in ‘Admin setting>>Setting>> Milestones’ and the added status details will display in Basic, Criteria and Milestones tabs (Admin setting>>Setting>> Milestones>>select created record>> click Manage).
3. Click button.
4. The Milestone Templates popup will appear.
5. Select the template, view details and click ‘Save to Registration status’ button.
6. An alert message will display as ‘Are you sure you want to add current Status(s) with selected Milestone Template Milestones?’’.
7. When ‘Ok’ button is clicked, the existing status will be replaced with selected template status for the change.
8. 
9. : Manage Registration –Milestone Template Popup
10. Click ‘Edit’ button to edit the status.
11. Click ‘Disable’ button to Disable the status.
12. Click ‘Cancel’ to cancel the information without saving.
13. Responsible person tab helps user to track concerned responsible persons with for Device registration.

Models

Registered models will be displayed to manage the devices. Model registration page will display as per below figure. User can edit the records and select/deselect the required details from edit registration page.

1. : Manage model registration page

Authorized Representative

1. Click on “Authorized Representative“ the page will be displayed as

1. : Manage Authorized Representative page
2. Click on to add representative of the company page will be displayed as per below figure.

1. : Add Authorized Representative
2. Click on ‘Save’ button after adding the details.
3. The record will be added in the grid.

Therapeutic details, Packaging and Organization(s)

Therapeutic details, Packaging and Organization(s) for a registration in the manage registration page will populate saved details automatically. Below Figure will provide an overview of the Therapeutic Details tab.

1. : Manage Registration Therapeutic details Page

If user skipped adding this information during registration creation, user can use ‘Edit’ button provided for each of these tabs to add the information.

1. Click Toggle menu to enter Model and other device details for all the devices in the registration.
2. Click ‘Edit’ button, user will see a screen similar as shown below.

1. : Edit Registration Page
2. Select/Deselect the checkboxes to edit the information.
3. Expand the Formulations, click a value in the right, user will see associated information in the left. This will let user view the information before adding or removing it.
4. Therapeutic details, Packaging and Organization(s) (Manufacturing sites/Distributors) is designed in a similar sequence.
5. Click ‘Save’ to save the information.
6. Click ‘Finish’ button and ‘Ok’ button to add the required records to Devices.

Documents

1. Click Documents tab to view a list of documents associated with the Devices as shown below.

1. : Registration Documents Tab

2. Select a record, click ‘Edit’ from Actions, page will be redirected to Edit ‘Document Details’ page

1. : Registration Edit Documents Tab

3. Fill up the above required fields. 4. Click ‘Save’ to save the document details to the device. 5.

Interactions

The Interaction module helps you view and track the interactions between the different actors, in the application. An Interaction can happen between Regulatory Agency and a Pharmaceutical Company or a third-party agency. Interaction Module has been divided into following sub modules depending on the query types. All the Queries related to different Health Authorities and Agencies can be managed here.

1. : Interaction Grid

Add Interactions To add an Interactions, follow the below steps:

1. Click +Interactions
2. The page will display as shown below
3. Add all the required information and select a user from ‘Assign Users’ to assign the record to a particular user.
4. Click on save to add the Interactions.
5. The new record will be created in the listing/grid view.
6. Email will be triggered to the assigned user
7. The assigned user can login and update the interactions record.

1. : Add Interactions Page

Manage Interactions 1. Select a record in the Interactions homepage and click the ‘Manage’ button. 2. Page will be displayed as shown below

1. : Manage Interactions Page

3. Select the information or update and click on Save button in Interaction details tab.

1. The details will be added to the record.
2. Click Audit button to view every action in audit history popup.
3. Documents – refer to section 5.4.9 Products>> Associated Documents.
4. Status – refer to section Refer section 8.1.1.3.2. Application Details >>>> Status tab

Edit, Disable and Audit Interactions

1. 1 Select a record in the Interactions homepage and click the ‘Edit button.
2. Edit Interaction page will be displayed.
3. Enter the relevant information and click on update button.
4. The details will be updated to the record in the grid.
5. Cancel button to exit the page without saving information.
6. Click on disable button to remove the record
7. Click Audit button, to view every action in audit history popup.

1. : Edit Interactions Page

Task and Sub Task

1. Select a record in the Interactions homepage.
2. Click the ‘+ Task’ button to add the task for Interactions.
3. Enter the relevant information in ‘Add Interactions Task’ page, and to assign the task, select user from ‘Assign To’ dropdown. Click on ‘Save’
4. Email will be triggered to the assigned user for Task to perform
5. The Business administrator user or assigned user can login and update status for the sub task
6. Click on ‘+ Subtask’ button to add a subtask for an Interaction.
7. Enter the relevant information in ‘Add Sub Task’ page, and to assign the subtask, select user from ‘Assign To’ dropdown. Click on save.
8. An email will be triggered to the assigned user.
9. Cancel button allows user to exit the page without saving the information.
10. Select the record to edit the details for Interaction Task and SubTask .
11. Click on disable button to remove the record from Interaction Task and SubTask
12. Click Audit button, to view every action in audit history popup.

.

1. : Task And Subtask In Interactions

Commitments

All the Commitments related to Registrations / Applications can be managed and monitored in this section.

1. : Device Commitments Home Page

Add Commitments To add a Commitment, follow the below steps: 1. Click on for Navigating to “Add Commitment” page 2. Select the required information in the below shown fields. 3. Depending on the filters, Registration will be appearing. 4. Click on Save. 5. A New record will be populated in the commitment Grid as shown in figure 230.

1. : Add Commitment Page

Manage Commitments

1. Select a record in the Commitments homepage and click the ‘Manage’ button.
2. Page will be displayed as shown below
3. Select the information or update and click on Save button in Commitment details tab
4. The details will be added to the record
5. Documents – refer to section 5.4.9 Products>> Associated Documents.
6. Status – refer to section Refer section 8.1.1.3.2. Application Details >>>> Status tab

1. Manage Commitments Page

Edit , Disable , Audit Commitments To Edit a Commitment, Follow the below step: 1. Select a record from the commitment grid, click on Actions button >>>> Edit as shown below:

1. : Edit for commitments

2. fill-up the required details as per below figure & click on save. 3. Click on disable button to remove the record and listed under the disabled records 4. Click Audit button, to view every action in audit history popup. 5. Click Interaction to Navigate to Interaction page

1. : Edit Commitment Page

Task and Sub Task

• • • 1. Select a record in the Commitment homepage.
      2. Click the ‘+ Task’ ‘button for commitment.
      3. Enter the relevant information in Add Commitment Task Page and to assign the task, select user from ‘Assign to dropdown, click on save’
      4. Email will be triggered to the assigned user for Task to perform.
      5. The Business administrator user or assigned user can login and update status for the Subtask
      6. Enter the relevant information in Add Commitment Sub Task Page and to assign the subtask, select user from ‘Assign to dropdown, click on save’
      7. Email will be triggered to the assigned user for Task to perform.
      8. The Business administrator user or assigned user can login and update status for the sub Task’
      9. Select the record to edit the details for commitment Task and Sub Task
      10. Click on Disable button to remove the record from commitment Task and SubTask
      11. Click Audit button to view every action in audit history popup

1. : Task and Sub Task for Commitments

Obligations

All the Obligations related to Registrations can be managed and monitored in this section.

1. : Obligation, Task & Sub Task Grid

Add Obligations To create / Add and Obligation follow the below steps: 1. Click on for Navigating to Add Obligation Page. 2. Select the required information in the below shown fields. 3. Depending on the filters, Registration will be appearing. 4. Click on “Save”.

1. : Add Obligation Screen

5. A record will be created in the grid shown in Figure 286. Manage Obligations

1. Select a record in the Obligation homepage and click the ‘Manage’ button.
2. Page will be displayed as shown below
3. Select the information or update and click on Save button in Obligation details tab
4. The details will be added to the record.
5. Documents – refer to section 5.4.9 Products>> Associated Documents
6. Status – refer to section Refer section 8.1.1.3.2. Application Details >>>> Status tab

1. Manage Obligation Page

Edit ,Disable , Audit Obligations To Edit an Obligation, select an Obligation Record from the Grid as shown in Figure 287 & click on Edit button

1. To Edit an Obligation, select an Obligation Record from the Grid as shown in screen& click on Edit button
2. Update the required details as per below screen & click on save.
3. Click on disable button to remove the record and listed under the disabled records
4. Click Audit button, to view every action in audit history popup.
5. Click Interaction to Navigate to obligation page

1. : Edit Obligation Page

Task and Sub Task 1. Select a record in the Obligations homepage. 2. Click the ‘+ Task’ button.

1. Enter the relevant information and click Assign To dropdown to assign to a user/team
2. Email will be triggered to the assigned user for Task to perform
3. The Business administrator user or assigned user can login and update status for the Sub task
4. Enter the relevant information in Add Sub Task Page and to assign the subtask, select user from the ‘Assign To’ dropdown. Click on ‘Save’
5. Email will be triggered to the assigned user for Sub Task to perform
6. The Business administrator user or assigned user can login and update status for the sub task
7. Select the record to edit the details for Obligations Task and Sub Task
8. Click on Disable button to remove the record from Obligations Task and Sub Task
9. Click Audit button to view every action in audit history pop up

1. : Tasks & Sub Tasks for Obligations

Local Updates

Local Update Module helps to define country specific changes or modify the changes distributed from the Global Team to meet the local requirements. Once the change submission set is finalized, you can assess the change impact on the relevant records and track the submission to authorities for approval. An LU is referred to as ‘Variation’ in European Union countries and referred as ‘Supplements’ in the United States countries. Clicking on Local Updates tab, user will be directed to the Local Updates homepage as shown in the below screen. The following details will be displayed on the page:

• • • 1. A list of all created Local Update records.

2. Buttons : Add, Manage and Disable. 3.‘Audit’ for each record. 4. ‘Disabled Records’ checkbox. 5.‘Completed Records’ Checkbox 6. ‘Archived Records’ Checkbox 7. Inactive Records Checkbox 8. My Favorites

1. : Local Update Homepage

Add Local Updates To add a Local updates, below are the steps to follow: 1. User Click the ‘+Local Update’ icon in Local Updates Homepage. 2. ‘Create Local Update ‘ wizard will open as shown below. 3. The first wizard ‘Registrations’ will be displayed. 4. Select Filter to view Registrations in the listing.

1. : Create Local Update – Select Registrations Page

5. Select the single or multiple registration(s) and click . 6. The second wizard ‘Update Details’ will be displayed

1. : Create Local Update – Update Details Page

7. Enter/select the required information. 8. If button is selected, user will be redirected to third wizard or click back button to go to first wizard. 9. The third wizard ‘Changes’’ will be displayed.

1. : Create Local Update – Changes Page

10.Click +Change to add the change for the Local update

1. : Create Local Update – Add Change
2. Enter the change information click on Save button

1. : Create Local Update – Add Change Grid

12. User can Add multiple changes as per the requirement 13. Click Delete button to delete the created changes. 14. Click button to add the Local Update to the listing. 15. When user selects single registration, update details and corresponding change while creating a Local update. Then upon clicking ‘Save &Finish’ button, one Local Update for each registration will be created. 16. When user selects multiple registration, update details and corresponding changes while creating a Local update. Then upon clicking ‘Save & Finish’ button, one Local Updates for multiple registration will be created. 17. When user select multiple registrations and if ‘Create multiple Local Updates when Finished?’ option is checked and update details, corresponding changes while creating a Local update. Then upon clicking ‘Finish’ button, multiple Local Updates for each registration will be created. Manage Local Updates You can enter specific information for a Local Update record through Manage button. To Manage Local Updates, below are the steps to follow: 1. Select a record in the Local Update homepage and click the ‘Manage’ button. 2. By default, user will see the following toggle tabs on the screen: a. Basic Information b. Changes c. Impact Assessment d. Documents e. Submission Status f. Registration Update 3. You will be able to enter the details for the first Basic information in the toggle menu.

Basic Information tab:

The Basic information tab will be displayed in Manage Local Update as a default tab.

• • • 1. The Basic Information will have selected registrations from create Local update page.
      2. Enter/update the information and click save button to save the respective details.
      3. Responsible person grid help you track concern persons with the Update
      4. Archived and Completed check box will help users to mark the Local updates as Archived or Completed.

1. : Manage Local Update – Basic Information Page

Changes tab:

The Changes tab will be displayed in Manage Local Update. The Changes tab will have created changes from create Local update. User can Add, Edit and Disable ‘Changes’ details as shown below.

1. : Manage Local Update – Changes Page

Click the ‘+Change’ icon in Changes tab.

1. : Create Local Update – Add Change Popup
2. Enter the relevant information for the change and click Save button.
3. Click ‘Cancel’ button, to close the popup without saving the data.
4. Upon clicking on save, the change details will be added to the grid.
5. Click on Edit button to edit the records
6. Select the change record and click on Disable button to remove the record and will be listed under Disabled Records.
7. Click Audit button, to view every action in audit history popup.

Impact Assessment

The Impact Assessment details can be added in Manage Local Update. When user clicks a registration the change(s) will be displayed and for each change the impact assessment can be added.

1. : Manage Local Update – Impact Assessment Page

Click the Registration Id, all the added changes will display in the ‘Changes’ listing. Select a change from Changes section. Click Delete button to delete the change. Click ‘+’Impact Assessment’’ button. Impact assessment popup will display.

1. : Manage Local Update –Add Impact Assessment Popup.
2. If Submission not required option is selected then ‘Is Registration Update Required’ option will appear in impact assessment popup.
3. Select Impact Assessment, enter comments and click on Save button.
4. Upon save, the impact assessment details will be added to the change.

Documents

The Documents details can be added in Manage Local Update. You can link documents by clicking on tab. 1. Click the ‘+Link Existing Document’ button in Document tab.

1. : Manage Local Update – Link Existing Documents Page
2. The List with all documents will display in a page as shown in the image.

1. : Manage Local Update – Add Link Existing Documents Page
2. The page allows user to select the document to Attach. You can Select one or more files and click on Attach Button or Cancel to go back to previous page.
3. Once the documents are attached user will be redirected to document page.
4. Click on Edit button to edit the records
5. Select the change record and click on Disable button to remove the record and will be listed under Disabled Records.
6. Click Audit button, to view every action in audit history popup.

Submission Status

The Submission Status details will be added in Manage Local Update. user can select and enter details by clicking on tab. The Sequence created changes from Impact Assessment tab will display in Submission status ‘Changes’ section listing.

• • • 1. Click the Registration Id, all the added changes will display in the ‘Changes’ listing.
      2. Select a change from Changes section.
      3. Enter the Variation number and comments in Basic information tab.
      4. Click Save button to Save the details.

1. : Manage Local Update – Submission Status Page
   • • 1. Click ‘+Status’ as shown below
       2. The Add status pop will appear.
       3. Enter all the information and click on Save button.

1. : Manage Local Update – Submission Status Add Status Popup

8. Click on edit option to edit 9. Edit popup will appear as

1. : Manage Local Update Edit Status page

10. Click ,enter name and click on Save.

1. : Manage Local Update – Submission Status Save As Template Popup

11.The template will save in ‘Admin setting>>Setting>> Milestones’ and the added status details will display in Basic, Criteria and Milestones tabs (Admin setting>>Setting>> Milestones>>select created record>> click Manage). 12. Click button 13. The Milestone Templates popup will appear. 14. Select the template, view details and click ‘Save to Local Updates Change status’ button. 15. An alert message will display as ’ Are you sure you want to override current Status(s) with selected Milestone Template Milestones?’. 16. When Ok button is clicked, the existing status will override with selected template status for the change.

1. If Status is not added in the Status tab, then upon clicking on override ok button, selected template status will be added to the listing.

1. : Manage Local Update–Submission Status Milestone Template Popup
2. Click edit button to edit the status.
3. Click Delete button to delete the status

Substance

Master File

This module helps to create and manage substance master files Login to the application and click on the Substance tab from the side menu bar. Substance home page will be displayed as shown in the below screen.

1. : Substance Home Page

Add Substance

1. Click on + Substance to open Add Substance window as shown in the below screen.

1. : Add Substance Window
2. Click the ‘+Substance icon in Substance Homepage.
3. ‘Add Substance page will open.
4. Enter the Substance information and click ‘Save’ button to save the record.
5. Cancel button allows user to exit the page without saving the information.
6. Reset button to reset the information.

1. : Add Substance popup

Manage Substance

• • • 1. Select a record in the Substance homepage and click the ‘Manage’ button.
      2. The page will be directed to the Basic info Details page as shown below.

1. : Manage Substance page

Add Basic Info Details Basic info details information for the Substance, will be shown in the read only format. Select the Basic Info details 2. Enter the relevant information and click ‘Save’ button to save the record. Associated Documents Click Associated Document tab where all attached documents are displayed, user will have provision to directly link the existing documents or add new documents to the respective substance.

1. : Associate Document Page

To add New Documents to Substance, below are steps to follow: 1. Click on ‘Add Document’ button. 2. Select the files for uploading. 3. Enter the required information and click on save button.

1. : Add Document Page

1. : Add New Document Details Page

To link existing documents to device, below are the steps to follow: 1. Click on ‘Link Existing Documents’ button. 2. Select/check mark the files and click on Attach button.

1. : Link Existing Document to Substance

3. Select the document and click on Attach. The document will be added to the list of documents in the page. 4. Click Edit button to edit the Document Properties. 5. Click button to delete the document from the listing.

Application

Click on the Substance tab, go to application module to create an application for the substances. Application home page will be displayed as shown in the below screen.

1. : Application Homepage

The following information will display on the page: 1. A list of all the Applications that have been added. 2. Buttons: + Application, Manage, View and Disable. 3. ‘Audit’ for each record. 4. ‘Disabled Records’ checkbox.

Add Application

To add Application, below are the steps to follow: 1. Click +Application icon in Application Homepage. 2. ‘Create Application wizard will open as shown in the below screen.

1. : Create Application All Substance Page

3. The first wizard ‘Select Substance will be displayed. 4. User will be allowed to select Substance. 5. Select the Substances from the listing and click button. 6. The second wizard ‘Choose Countries’ will be displayed.

1. : Create Application Choose Countries Page

7. Select the Country Group, Application Category, Countries, Authority , comments and Click or Finish button. 8. If user selects Finish button, the created record will be displayed in Application listing. 9. If button is selected then user will be redirected to third wizard of Create Application

1. : Create Application – Details to Create Page

10. The third wizard ‘Other Details to Create Application will be displayed. 11. Select the document and click on Save button to save the selection. 12. Click button to complete the Create Registration process.

Manage Application

Manage application contains

• 1. Basic info
  2. Documents

1. Select the application and click on manage the tab will be displayed as below

1. : Manage Application Home Page

2. Enter the relevant data in Basic info tab click on “SAVE” button. 3. Managed data will be saved in application home page Documents: Click Associated Document tab where all attached documents are displayed, user will have provision to directly link the existing documents or add new documents to the respective Application.

1. To add New Documents to Application, below are steps to follow
   1. Click on ‘Add Document’ button.
   2. Select the files for uploading.
   3. Enter the required information and click on save button.
2. To link existing documents to device, below are the steps to follow:
3. Click on ‘Link Existing Documents’ button.
4. Select/check mark the files and click on Attach button.
5. Select the document and click on Attach. The document will be added to the list of documents in the page.
6. Click Edit button to edit the Document Properties.
7. Click Unlink button to delete the document from the listing.

Reports

User can use this tab to track the progress of a record. Clicking this Reports tab will take user to the Reports homepage where user will see the following tabs on right hand side section:

• General Report
• Dynamic Reports
• Quality Check Reports
• MAS Report
• Audit Trials

General Reports:

Reports section will allow the user to generate data in a specified format. This information can be used to track, analyze, monitor information as per user requirement. It can also be used to make correlations, decisions etc. The reports are grouped based on a common factor. The following tab will reflect in LHN by clicking on General reports:

• Product Reports
• Registration Reports
• Manufacturing Reports
• SPOR Reports
• Compliance Reports

Product Reports

Following Sub-Report will appear under Product Reports:

• Standard Reports

Standard Reports

1. : General Report- Standard Reports Screen

Generate Standard Reports steps:

1. Click Reports tab, user will be navigated to General Reports tab.
2. Click on Standard Reports
3. Standard Reports page will have two sections, select Search Criteria and a grid.
4. The grid will show all records by default and user can see the status against each record.
5. Enter the Search criteria and click Generate,
6. User will see the results for selected combination of the fields in a grid format
7. User can download the Report by clicking Export to Excel or Export to PDF button
8. The Record status are:
   1. In-Progress
   2. For Review
   3. Reviewed
   4. For Approval
   5. Approved
   6. Review Revert
   7. Approve Revert

Registration Reports

Following are the Sub-Reports that appears under Registration Reports:

• Registration Status Report
• Marketed Registrations
• Renewal Pending Registrations

Registration Status Report The following will display in the Registration Status Report.

1. : Registration Status Report Screen

Generate Registration Status Report steps:

1. Click Reports tab.
2. Navigated to General Reports tab.
3. Click on Registration Status Report under Registration Reports
4. Registration Status Report page has two sections, Select Search Criteria and a grid.
5. The grid will show all records by default and user can see the status against each record.
6. Enter the Search criteria and click Generate, User will see the results for selected combination of the fields in a grid format
7. User can download the Report by clicking Export to Excel or Export to PDF button

1. : Generated Registration Record

Marketed Registrations The following will display in the Marketed Registrations Report.

1. : Marketed Registrations Report Screen

Generate Marketed Registrations Report steps:

1. Click Reports tab.
2. You will be navigated to General Reports tab.
3. Click on Marketed Registrations under Registration Reports
4. Marketed Registrations page has two sections, Select Search Criteria and a grid.
5. Enter the Search criteria and click Generate.
6. User will see the results for selected combination of the fields in a grid format
7. User can download the Report by clicking Export to Excel or Export to PDF button

Renewal Pending Registrations The following will display in the Renewal Pending Registrations Report.

1. : Renewal Pending Registrations Screen

Generate Renewal Pending Registrations steps:

1. Click Reports tab.
2. You will be navigated to General Reports tab.
3. Click on Renewal Pending Registrations under Registration Reports
4. Renewal Pending Registrations page has two sections, Select Search Criteria and a grid.
5. The grid will show all records by default and user can see the status against each record.
6. Enter the Search criteria and click Generate,
7. User will see the results for selected combination of the fields in a grid format
8. User can download the Report by clicking Export to Excel or Export to PDF button

Manufacturing Reports

Manufacturing Reports The following will display in the Manufacturing Reports.

1. : Manufacturing Reports Screen

Generate Manufacturing Report steps:

1. Click Reports tab.
2. Navigated to General Reports tab.
3. Click on Manufacturing Reports under Manufacturing Reports
4. Manufacturing Reports page has two sections, Select Search Criteria and a grid.
5. Enter the Search criteria and click Generate
6. User will see the results for selected combination of the fields in a grid format
7. User can download the Report by clicking Export to Excel button

SPOR Reports

SPOR Reports The following will display in the SPOR Reports.

1. : SPOR Reports Screen

Generate SPOR Report steps:

1. Click Reports tab.
2. Navigated to General Reports tab.
3. Click on SPOR Reports under SPOR Reports
4. SPOR Reports page has two sections, Select Search Criteria and a grid will display .
5. User can download the Report by clicking Export to Excel button

Compliance Reports

xEVMPD Reports The Following will Display in xEVMPD Reports

1. Click Reports tab.
2. Navigated to General Reports tab.
3. Click on xEVMPD Reports under Compliance Reports
4. xEVMPD Reports page has two sections, Select Search Criteria and a grid.
5. Enter the Search criteria and click Generate
6. User will see the results for selected combination of the fields in a grid format
7. User can download the Report by clicking Export to Excel and Export to PDF button

1. : Compliance Reports Screen

Dynamic Reports

Dynamic Report helps user in configuring custom reports in the application.

1. : Dynamic Report Screen

Generate Dynamic Reports steps: Follow the below steps to create a dynamic report

1. Click Reports tab.
2. Navigated to Dynamic Reports Page.
3. Dynamic Reports has three sections: Select Module, Select Search Criteria ( Fields, Filter ).
4. User can select any module from search criteria by using field and filter symbol.
5. The grid will show all records by default and user can see the status against each record.
6. Click Generate, user will get a report for records containing the search criteria .

Note: Maximum Number of Field & Filter selection is limited to 15

1. : Dynamic Report Generate Report Screen
2. Click ‘Export to Excel’ button to export the data to excel.
3. Click ‘Back to Search’ button to go to previous page.
4. Enter name in ‘Query Name’ and click on ‘Save Query’ button, the saved query will display in ‘Query’ dropdown.
5. Click Delete button to Delete the saved query.
6. Click Query Dropdown value to update the saved query and generate report again.
7. Select the Query from the dropdown and click ‘Share Query’ button to share the query with other users or role.

1. : Dynamic Report Share Query Popup

NOTE: Based on the number of field selection and filter criteria the response time may vary and the application will show the following alert in case the query takes additional time.

1. : Dynamic report alert pop up

Quality Check Reports:

The following will display in the Quality Check Reports.

1. : Quality Check Reports Screen

Generate Quality Check Reports steps:

1. Click Reports tab, user will be navigated to General Reports tab.
2. Click on Quality Check Reports
3. Quality Check Reports page will have two sections, select Search Criteria and a grid.
4. The grid will show all records by default.
5. Enter the Search criteria and click Generate,
6. User will see the results for selected combination of the fields in a grid format
7. User can download the Report by clicking Export to Excel button

MAS Reports:

The following will display in the MAS Reports.

1. : MAS Search Screen

Generate MAS Reports steps:

1. Click Reports tab, user will be navigated to General Reports tab.
2. Click on MAS Reports
3. MAS Reports page will have two sections, select Search Criteria and a grid.
4. Enter the Search criteria and click Generate, user will get a report for records containing the search criteria.

1. : MAS Reports Screen
2. Click ‘Export to Excel’ button to export the data to excel.
3. Click on “Export to PDF” button to export the data to PDF.
4. Click ‘Back to Search’ button to go to previous page.

Audit Trails

1. Click on Audit trail tab.
2. Navigated to Audit log page.

1. : Audit log screen
2. User can select any module in search criteria.
3. system should automatically generate electronic audit trails for all operator entries.
4. User can filter based on Module, Section like Devices, Users, From and To Date.
5. The following information will be available in the audit trails:

• Details of the user, to identify the changes performed in the data and module.
• Track ID and Date and Time of changes made.
• Action Type.
• Headings ‘Field name, Before change and After change’.

7. The old data will display in Before change column and new data will display in After change column as shown in the Figure 8. The data can be exported to Excel using the button . 9. The data can be exported to PDF using the button .

1. : Audit log page

Legacy Audit Trails

Legacy audit trails feature helps user view / Export audit information, which migrated from another system (Legacy data). To Run a Legacy audit trails report go to the below navigation.

1. : Legacy Audit trails navigation

1. Select the required module and filters from the dropdown. 2. Click on Generate.

1. : Legacy Audit Trails Generate & Export to Excel

Note: Filters are subjected to change based on the migrated data

Custom Reports

While creating Dynamic Reports there is an option to select “Is Custom Report” Check box.

1. Click on custom Reports from below navigation.
2. Based on the report created in Dynamic report and shared , respective reports will be available in “Select Report” Dropdown
3. Select the required report from the dropdown and give filter values
4. Click on Generate .

1. : Custom Reports Page

Comparison Report

To run “Comparison Report” user should follow the below navigation as shown below: Reports>> Comparison Report. Comparison Report helps user identifying the updated data in last 30 days by highlighting the updated data.

1. : Comparison Report

Batch Update

Batch Update feature helps users to update attributes / Field data of multiple records at once.

11.1. Create Batch Update

To create a Batch Update for Products and Registrations Refer the sections 5.4.15 & 8.1.4.4. respectively. Once the Batch Update created, record will be populated in Batch Update Grid with Module identifier.

1. : Batch Update Grid with Module Identifier

11.2. Manage Batch Update

Manage Batch Update Provides user the following: a. Basic Information b. Actions c. Validate and Apply

11.2.1. Basic Information

Click on manage then Basic Information page will appear.

1. : Basic Information Page

11.2.2. Actions

Add Action provides feature to Add and Update attributes of the Batch Updates.

1. : Actions Grid

To Add & Update follow the below steps: 1. Click on button to initiate the action. 2. Select the Action Name, Field Name and Action type (Add / Update)

1. : Actions Tab

Notes: Incase user selects Add, Old value field will stay disabled. It only comes for Update actions For Products>Shelf life and Storage condition only Update action will be available. Incase user selects “Update” action and there is no old value to update . system will show an alert “No existing value to update” Click “ok” to continue. 3. Click on button to add condition to your action for validation.

1. : Condition Pop up

4. Upon clicking “Add Condition”, Condition will list as shown below with edit and delete options.

1. : Condition List

11.2.3. Validate and Apply

1. Click on save and move to Validate and Apply. 2. Select the Required Records want to update & Click on Validate.

1. : Validate and Apply Grid

3. Give the validation summary and click on Submit. 4. Similarly select the required product & Click on Apply. 5. Give the Apply Summary and Click on Submit. Note: Validation Unsuccessful Records cannot be Applied & System will not allow to validate again once unsuccessful. In that case you need to create a new Batch Update.

Admin Settings

The Admin module allows the System Administrator to configure and maintain the SPAR Application. The admin privileged user will have access to following tabs once ‘Admin Settings’ tab is clicked:

• Users
• Roles
• Library
• Settings

Users

The Users page will be displayed all the registered users in the application with assigned role will be listed as shown in the Figure:

1. : Users Page

Below are the steps to add New User.

1. Click ‘+New User’, page will be directed to the Add User Details as shown in the Figure.

1. : Add User Details Page
2. The email address will populate in the Person Library dropdown.

Note: To display email address in the Persona Library dropdown:

• Navigate to Admin Settings >> Library, expand toggle menu
• Click Person Library
• Click +Person Library, enter details and click Save button.
• User will receive an email notification with Login details.
• The added user email address will be listed in Admin Settings>>Library>>Users>>+New User>> Person Library dropdown.
• Refer section 12.4.10

1. Select the email address from the dropdown. The details will display as shown in the Figure.

1. : Add User Details Page With Data
2. Select the Role type , Roles , Affiliates and click on Save button, the record will display in Users listing.
3. Scroll towards right from the listing, Block, Disable, Edit, Details, Audit details buttons will display for each user.

1. Block option
2. Click Block button to stop the User Account (or) E-signature.
3. When Block button is clicked, the alert message will display with OK and Cancel buttons.
4. Click OK button, the user account will be suspended, and Blocked button will change to Unblock button. User can be Unblocked if requested.
5. When more than 5 login attempts are failed then email notification will trigger to the user and automatically the User Account will be blocked, and button will display as
6. Click User Disable button to deactivate the Account.
7. When Disable button is clicked, the alert message will display with OK and Cancel buttons.
8. Click OK button, the user account will be disabled and Disable button will change to button.
9. User account can be enabled if requested. The disabled record will be moved to Disabled Users list.
10. To view the disabled users, click Show Disabled Users check box, the users will populate in the listing.
11. Click Edit button , the page will be redirected to the Edit User Details as shown in the Figure.

1. : Edit User Details

• Edit the Roles and Affiliates if required and click on Save button. The record will be updated with entered data.
• Click Reset button to clear any recent unsaved changes.

1. Click Details button , the page will be redirected to the User Details as shown in the Figure.

1. : View User Details
2. Click Audit button , a popup will display with all audit data for the selected user as shown in the Figure.

1. : Audit History Details
2. Click to export the data to PDF/Excel.

Note:

• When the button is clicked the changes will be discarded.
• When the Close button is clicked, the popup or page will be closed.

Roles

The below roles are defined in the current system.

• Global Data Manager– This User will have access to Dashboard, Products, Product Assigned to, Devices, Documents, Submission, Substances, Batch Update, Reports and will be able to enter and manage data. User will also be able to assign the data related tasks to others.
• Global Registration Manager– This User will have access to Dashboard, Documents, Registration, Application, Sequences , Dossiers ,Global Update , Local Update, Interaction, Commitment , Obligation , xEVMPD and will be able to enter and manage it. User will also be able to assign the data related tasks to others.
• Local Registration Manager– This User will have written access to Dashboard, Registrations, Local Updates, Interactions, Obligations , Commitments, Reports and will be able to enter data and manage it . User will also be able to assign the data related tasks to others.
• System Administrator– This User will have access to Settings, Milestones, Notification template, Affiliates, Reports, Audit trails ,User Management and Library management and Read only access to all the data modules.
• Business Administrator– This User will have access to All the data related activities including Dashboard, Documents, Product, Device, Submissions, Substances, Reports and will be able to enter data, review it, approve it. He will also be able to assign the data related tasks to others.
• Reviewer– This User will be able to Review the assigned task.
• Approver– This User will be able to approve the assign task.
• Read Only – This user will have read only access to All the Modules.
• Read Reports View– This User will have Read access to Dashboard, Documents, Product , Device, Submissions, Substances, Batch update and Reports and will be able to generate Report but no download.
• Read Reports Download– This User will have Read access to Dashboard, Documents, Product, Device, Submissions, Substances, Batch update and Reports and will be able to generate and download Reports .
• For CPP – Business Administrator / Global Data Manager can access CPP

The following steps will walk user through the basic movement of a record between the roles. You will be guided as to how to signal the next person in line that your job is completed. Click the Roles tab. User will see the roles in the system and a short description that explains the various tasks that can be performed under each role.

1. : Role Details Page

Above screen provides an overview of the Role details page for the reference.

Add Roles

Click on + Role to add a new roles.

1. : Add Roles Page

After clicking on + Role the below popup will appear.

1. : Add Role Popup

Edit Roles

Click on Edit to edit Roles.

1. : Edit Role Page

Note : Standard & Pre-defined Roles are not available for Edit

Library

While entering the data in the application, user will find dropdowns which will allow user to select pre-entered data. The data for the dropdowns can be entered in the Library tab. This helps user to Add or Edit the data according to the requirement. Click toggle menu, the Library is divided into various segments as shown below:

1. Common
2. Devices
3. Documents
4. Products
5. Registration
6. Substances
7. MedDRA
8. Organization Collection
9. Substance Collection
10. Person Library
11. Product Family Collection
12. Library Mapping
13. Import Library Data
14. Country Group Mapping

When the user clicks on the ‘Library’ tab, the below page will be displayed:

1. : Library Page

Common Section

When user clicks Library, the Common tab will be displayed as default screen. Library to all the modules are grouped under Common section. 1. Click Common link, user will be directed to multiple tabs as shown in the below screen.

1. : Common Page

To add the values in Length, following are the steps to follow:

1. Click ‘+Length’.

1. : Add Length Details
2. A blank row will display in the table to enter the data.
3. Enter the Name, Code and Remarks.
4. Click on button, the status will change from to .
5. Repeat the above steps to add multiple rows.
6. Click on button, the status will change to In-Active and data will be disabled from ‘Units’ dropdown in the application.
7. Click , enter the data and click button, date will be updated.
8. Click Disable button to remove the record.
9. When Disable button is clicked, an alert message will display with OK and Cancel buttons.
10. Click OK button, the added record will be Disabled from the listing and the Disabled record will be moved to Disabled list.
11. To view the Disabled record, click ‘Show Disabled Records’ check box, the records will populate in the listing.
12. Click Audit button , a popup will display to view all the audit data.

Note: Adding data to below libraries follows the same process. Refer this section to add data element. Alternate Material Note: The added data will be available in the application, following is the navigation:

• Products>>Manage>> Packaging>>Primary Pack>>+Primary Pack, the data will be available in Alternate Material dropdown.

Color To add the values in Color, following are the steps to follow: Note: The added data will be available in the application, following is the navigation:

• Products>>Manage>> Formulations>>Physical characteristics>> +Physical characteristics, the data will be available in Color dropdown.
• Products>>Manage>> Packaging>>Primary Pack>>+Primary Pack>> Physical characteristics tab>> +Physical characteristics, the data will be available in Color dropdown.

Country Note: The added data will be available in the application, following is the navigation:

• Products >> Basic information > Brand Name , the data will be available in Country dropdown
• Submission >> All Application and Registration wizard >> Country Dropdown

Language Note: The added data will be available in the application, following is the navigation:

• Products>>Manage>> Packaging>> Primary Pack>>+Primary Pack, the data will be available in Language dropdown.
• Document>> Add Documents >>Upload file and Document Properties, the data will be available in Language dropdown.
• Submissions>>Registrations>> Manage>> Trademark, the data will be available in Application Language dropdown.
• Submissions>>Registrations>> Manage>> Primary>>Product info tab, the data will be available in Application Language dropdown.

Lead Time Type Note: The added data will be available in the application, following is the navigation:

• Submissions>>Registrations>> Manage>> Primary>> Status tab >>+Status, the data will be available in Lead Time Type dropdown.

Lead Time Unit Note: The added data will be available in the application, following is the navigation:

• Submissions>>Registrations>> Manage>> Primary>> Status tab >>+Status, the data will be available in Lead Time Unit dropdown.

Length Note: The added data will be available in the application, following is the navigation:

• Products>> Manage>> Formulations>> Physical characteristics>> +Physical characteristics, the data will be available in Units dropdown for fields like ‘Height +Units, Width + Units, External Diameter +Units, Depth + Units ‘ etc.,
• Products>> Manage>> Packaging>> Primary Pack>> +Primary Pack>>Physical characteristics tab>> +Physical characteristics, the data will be available in Units dropdown for fields like ‘Height +Units, Width + Units, External Diameter +Units, Depth + Units ‘ etc.,

Material Note: The added data will be available in the application, following is the navigation:

• Products>>Manage>> Packaging>> Primary Pack>>+Primary Pack, the data will be available in Material dropdown.

Nominal Volume Note: The added data will be available in the application, following is the navigation:

• Products>>Manage>>Formulations>>Physical characteristics>> +Physical characteristics, the data will be available in Nominal Volume dropdown.
• Products>>Manage>> Packaging>>Primary Pack>>+Primary Pack>> Physical characteristics tab>> +Physical characteristics, the data will be available in Nominal Volume dropdown.

Notification Module Note: The added data will be available in the application, following is the navigation:

• Admin Settings>> Settings>> Notification Templates >> +Notification Template, the data will be available in Module dropdown.

Notification Module Field Note: The added data will be available in the application, following is the navigation:

• Admin setting>>Notification Template>> Manage>> Criteria, the data will be available in Field Name dropdown.

Other Characteristics Code System Note: The added data will be available in the application, following is the navigation:

• Products>>Manage>> Formulations>>Other characteristics tab>>+Other characteristics, the data will be available in Code System dropdown.
• Products>>Manage>> Packaging>>Primary Pack>>+Primary Pack>> Other characteristics tab >> + Other characteristics, the data will be available in Code System dropdown.

PSUR Code Note: The added data will be available in the application, following is the navigation.

• Submissions>>Product>>Application>>Manage>>Basic Information, the data will be available in Code System dropdown.
• Submissions>>Device>>Registration>>Manage>>Basic Information, the data will be available in Code System dropdown.

Reason For In-Active Note: The added data will be available in the application, following is the navigation:

• Product >> Create >> Inactive
• Product >> Manage >> Basic Information >> Inactive
• Device >> Create >> Inactive
• Submissions >> Applications >> Manage >> Basic Info >> Inactive
• Submissions >>Global Updates >>Manage >>Basic Information >> Inactive

Country Group Note: The added data will be available in the application, following is the navigation:

• Products>>+Products>>Select Product Category as Marketable>>+Brand Name, the data will be available in Country Group dropdown.
• Interactions>>+Health Authority Interactions, the data will be available in Country Group dropdown.
• Application , Registration, Substances> Application Wizard > available in country Group Dropdown

Responsible Person Roles Note: The added data will be available in the application, following is the navigation:

• Product >> Manage >> Basic Information

Scoring Note: The added data will be available in the application, following is the navigation:

• Products>>Manage>> Formulations>> Physical characteristics>> +Physical characteristics, the data will be available in Scoring dropdown.
• Products>>Manage>> Packaging>> Primary Pack>>+Primary Pack>> Physical characteristics tab>> +Physical characteristics, the data will be available in Scoring dropdown.

Shape Note: The added data will be available in the application, following is the navigation:

• Products>> Manage>>Formulations>> Physical characteristics>> +Physical characteristics, the data will be available in Shape dropdown.
• Products>> Manage>> Packaging>> Primary Pack>> +Primary Pack>> Physical characteristics tab>> +Physical characteristics, the data will be available in Shape dropdown.

Shelf Life To add the values in Shelf Life, following are the steps to follow: Note: The added data will be available in the application, following is the navigation:

• Products>>Manage>> Packaging>> Primary Pack>>+Primary Pack>>+Shelf Life, the data will be available in Shelf Life + Units dropdown.

Shelf Life Type Note: The added data will be available in the application, following is the navigation:

• Products>>Manage>> Packaging>>Expand Toggle menu, Primary Pack>>+Primary Pack>>+Shelf Life, the data will be available in Shelf Life Type dropdown.

Storage Condition Note: The added data will be available in the application, following is the navigation:

• Products>>Manage>> Packaging>> Primary Pack>>+Primary Pack>>+Shelf Life>>Storage Conditions, the data will be available in Storage Condition dropdown.

Weight Note: The added data will be available in the application, following is the navigation:

• Products>> Manage>> Formulations>> Physical characteristics>> +Physical characteristics, the data will be available in Weight dropdown.
• Products>> Manage>> Packaging>> Primary Pack>> +Primary Pack>> Physical characteristics tab>> +Physical characteristics, the data will be available in Weight dropdown.

Devices Section

On Devices link under toggle menu, user will be directed to multiple tabs. Classification Note: The added data will be available in the application, following is the navigation:

• Devices>> Manage>>Basic Details >> Classification

Current status Note: The added data will be available in the application, following is the navigation: Submissions>>Devices>>Registrations>>Basic Details. The data will be available in dropdown. Device Usage Note: The added data will be available in the application, following is the navigation:

• Devices>> Manage>>Basic Details>>Device Characteristics , the data will be available in Device Usage dropdown.

Family Note: The added data will be available in the application, following is the navigation:

• Submissions>>Devices>>Registrations>>Manage>>Basic Details.

Identity System Note: The added data will be available in the application, following is the navigation:

• Devices>>Manage>>Model>>Identifier

Latex Information Note: The added data will be available in the application, following is the navigation:

• Devices>> Manage>>Basic Details >> Device Characteristics

Manufactured Item Note: The added data will be available in the application, following is the navigation:

• Devices>> Manage>>Device and Components>>Physical Characteristics tab>>Add Physical Characteristics, the data will be available in Manufactured Item dropdown.

Nomenclature System To add the values in Nomenclature System, following are the steps to follow: Note: The added data will be available in the application, following is the navigation:

• Devices>> Select a record and Manage>>+Basic Details, the data will be available in Nomenclature System dropdown.

Nomenclature Value To add the values in Nomenclature Value, following are the steps to follow: Note: The added data will be available in the application, following is the navigation:

• Devices>> Select a record and Manage>>+Basic Details, the data will be available in Nomenclature Value dropdown.

Operation Type Note: The added data will be available in the application, following is the navigation:

• Devices>>Manage>>Organization(s)>>Distributor

Sterility Indicator To add the values in Sterility Indicator, following are the steps to follow: Note: The added data will be available in the application, following is the navigation:

• Devices>> Manage>>Basic Details >> Device Characteristics ,the data will be available in Sterility Indicator dropdown.
• >> Manage>>Basic Details >> Device Characteristics

Sterility Method Note: The added data will be available in the application, following is the navigation:

• Devices>> Manage>>Basic Details >> Device Characteristics

Sterilization Requirement Indicator Note: The added data will be available in the application, following is the navigation:

• Go to Devices>> Select a record and Manage>>Click +Basic Details, the data will be available in Sterilization Requirement Indicator dropdown.
• Manage>>Basic Details >> Device Characteristics

Sub Category Note: The added data will be available in the application, following is the navigation:

• Submissions>>Devices>>Registrations>>Manage>>Basic Details>>Application Details

Title Of The Submission Note: The added data will be available in the application, following is the navigation:

• Submissions>>Devices>>Registrations>>Manage>>Basic Details>>Application Details

Type Note: The added data will be available in the application, following is the navigation:

• Devices>> +Device, the data will be available in Class dropdown.

Type Of GUDID Submission Note: The added data will be available in the application, following is the navigation:

• Submissions>>Devices>>Registrations>>Manage>>Basic Details>>Application Details

Type Of License Note: The added data will be available in the application, following is the navigation:

• Submissions>>Devices>>Registrations>>Manage>>Basic Details>>Application Details

Type Of Submission Note: The added data will be available in the application, following is the navigation:

• Submissions>>Devices>>Registrations>>Manage>>Basic Details>>Application Details

Documents Section

Click on Documents link under toggle menu, user will be directed to multiple tabs. Class Note: The added data will be available in the application, following is the navigation:

• Go to Documents>> +Document>>Document Properties, the data will be available in Class dropdown.

Type Note: The added data will be available in the application, following is the navigation:

• Go to Documents>> + Documents>>Document Properties, the data will be available in Type dropdown.

Products Section

Click on Products link under toggle menu, user will be directed to multiple tabs Associate Study Numbers Note: The added data will be available in the application, following is the navigation:

• Products (only Investigational) >> Manage >> Protocol >> Add Associate Study Numbers

Brand Name Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Click +Products>>Select Product Category as Marketable>>Click +Brand Name, the data will be available in Brand Name dropdown.

Business Unit Note: The added data will be available in the application, following is the navigation:

• Products>>Manage>>Basic Details>>Business Unit

Brand Name Type Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Click +Products>>Select Product Category as Marketable>>Click +Brand Name, the data will be available in Brand Name Type dropdown.

Characteristic Code Status Note: The added data will be available in the application, following is the navigation:

• Products >> Manage >> Formulations >> pharmaceutical product >> Add Pharmaceutical Product

Characteristics Code System Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Therapeutic Details>>Expand Toggle menu, click Interactions >> Click + Interactions details tab >>Click + Interactions, the data will be available in Code System dropdown.
• Products >> Manage >> Formulations >> pharmaceutical product >> Add Pharmaceutical Product

Characteristics Code Value Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Therapeutic Details>>Expand Toggle menu, click Interactions >>Click +Interaction Text>>Add data>> Click + Interactions details tab >>Click + Interactions, the data will be available in Value dropdown.

Combination Package Note: The added data will be available in the application, following is the navigation:

• Products>>Add Products>>Product Sub Category dropdown>>Combination Package

Comparator Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Select Products checkbox of Investigational Product Category and click Manage>> Click Protocol>>Click +Protocol, the data will be available in Comparator dropdown.

Competent Authority Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Organization(s)>>Expand Toggle menu, click Manufacturing >> Click + Manufacturing Sites>> Click Certificates tab>>Click GMP tab>>Click + GMP, the data will be available in Competent Authority dropdown.

Component Type Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Packaging>>Expand Toggle menu, Click Primary Pack>>Click +Primary Pack>>Click Component tab>>Click + Component, the data will be available in Component Type dropdown.

Confidential Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Organization(s)>>Expand Toggle menu, click Distributor >> Click + Distributor>> Click Business Operation tab>>Click + Business Operation, the data will be available in Confidential Indicator dropdown.

Confidentiality Indicator Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Formulations>>Expand Toggle menu, click Composition >> Click + Composition>>Click Active Substances tab>>Click + Substance, the data will be available in Confidentiality Indicator dropdown.
• Go to Products>>Manage>> Click Formulations>>Expand Toggle menu, click Composition >> Click + Composition>>Click Active Substances tab>>Click Reference Substance>>Click + Reference Substance, the data will be available in Confidentiality Indicator dropdown.

Data Carrier code system Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Packaging>>Expand Toggle menu, Click Primary Pack>>Click +Primary Pack>>Click Data Carrier Identifier tab>>Click +Data Carrier, the data will be available in Data Carrier Code System dropdown.

Data Carrier value Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Packaging>>Expand Toggle menu, Click Primary Pack>>Click +Primary Pack>>Click Data Carrier Identifier tab>>Click +Data Carrier, the data will be available in Data Carrier Value dropdown.

Denominator Unit Names Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click formulation>>Expand Toggle menu, Click Composition>>Click +Strength>>, the data will be available in Data Carrier Value dropdown.

Numerator Unit Names Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click formulation>>Expand Toggle menu, Click Composition>>Click +Strength>>, the data will be available in Data Carrier Value dropdown.

Prefix Name Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click formulation>>Expand Toggle menu, Click Composition>>Click +Strength>>, the data will be available in Data Carrier Value dropdown.

DMF Type Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Organization(s)>>Expand Toggle menu, click Manufacturing >> Click + Manufacturing Sites>> Click Certificates tab>>Click DMF tab>>Click + DMF, the data will be available in DMF Type dropdown.

Excipient Role Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Formulations>>Expand Toggle menu, click Composition>> Click +Excipient Role>>the data will be available in Excipient Role dropdown

Type of Combination Product. Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click on Basic Information>>Select Include Device checkbox >>the data will be available in Type of Combination Product dropdown

Frequency Occurrence Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Therapeutic Details>>Expand Toggle menu, click Undesirable Effects >>Click +Undesirable Effects >>Add data>>Click Undesirable Effects details tab>> Click +Undesirable Effects details, the data will be available in Frequency Occurrence dropdown.

Function Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Formulations>>Expand Toggle menu, click Composition >> Click + Composition>>Click Active Substances tab>>Click + Substance, the data will be available in Function dropdown.
• Go to Products>>Manage>> Click Formulations>>Expand Toggle menu, click Composition >> Click + Composition>>Click Excipients tab>>Click + Excipient, the data will be available in Function dropdown.

Gender Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Therapeutic Details>>Expand Toggle menu, click Indications >>Click + Indications>>Add data>>Click Specifics tab>> Click +Specifics, the data will be available in Gender dropdown.

Grade Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Formulations>>Expand Toggle menu, click Composition >> Click + Composition>>Click Active Substances tab>>Click + Substance, the data will be available in Grade dropdown.
• Go to Products>>Manage>> Click Formulations>>Expand Toggle menu, click Composition >> Click + Composition>>Click Excipients tab>>Click + Excipient, the data will be available in Grade dropdown.

Interaction Type Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Therapeutic Details>>Expand Toggle menu, click Interactions >>Click +Interaction Text>>Add data>> Click + Interactions details tab >>Click + Interactions details, the data will be available in Interaction Type dropdown.

Label Term Note: The added data will be available in the application, following is the navigation:

• Products >> Manage >> Therapeutic Details >> Indications >>Add Indication Details
• Products >> Manage >> Therapeutic Details >> Contraindications >>Add Contraindication Details
• Products >> Manage >> Therapeutic Details >> Undesirable Effects >>Add Undesirable Effects Details

Manufacturing Operation Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Organization(s)>>Expand Toggle menu, click Manufacturing >> Click + Manufacturing Sites>> Click Manufacturing Operation tab>>Click + Manufacturing Operation, the data will be available in Manufacturing Operation dropdown.

Pack Size Unit Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Packaging>>Expand Toggle menu, Click Primary Pack>>Click +Primary Pack, the data will be available in Pack Size+ Unit dropdown.

Pack Type Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Packaging>>Expand Toggle menu, Click Primary Pack>>Click +Primary Pack, the data will be available in Pack Type dropdown.

Packaging Name Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Packaging>>Expand Toggle menu, Click +Add Packaging, the data will be available in Packaging Name dropdown.

Pharma Form Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Click +Products, the data will be available in Pharma Form dropdown.

Pharmaceutical dosage form Note: The added data will be available in the application, following is the navigation:

• Submissions>>Products>>Registrations>>Basic Details>>Pharmaceutical dosage form

Phase Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Select Products checkbox of Investigational Product Category and click Manage>> Click Protocol>>Click +Protocol, the data will be available in Phase dropdown.

Physiological Condition Note: The added data will be available in the application, following is the navigation:

• Products >> Manage >> Therapeutic Details >> Indications >>Specifics >>Add Specifics
• Products >> Manage >> Therapeutic Details >> Contraindications >> Specifics >>Add Specifics
• Products >> Manage >> Therapeutic Details >> Undesirable Effects >> Specifics >>Add Specifics

Population Note: The added data will be available in the application, following is the navigation:

• Products (Only Investigational)>> Manage >> Protocol >> Protocol Information >>Add Protocol

Product Category Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Click +Products, the data will be available in Product Category dropdown.

Product Family(Active Name) Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Click +Products, the data will be available in Product Family dropdown.

Product Intended Label Term Note: The added data will be available in the application, following is the navigation:

• Products >> Manage >> >> Therapeutic Details >>Indications >> Add Intended Effects Details

Product Type Note: The added data will be available in the application, following is the navigation:

• Products>>Click +Products, the data will be available in Type dropdown.

Protocol Roles Note: The added data will be available in the application, following is the navigation:

• Products (Only Investigational)>> Manage >> Protocol >> Request New Protocol Information >> Assign to

Quantity Type Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Formulations>>Expand Toggle menu, click Composition >> Click + Composition>>Click Active Substances tab>>Click + Substance, the data will be available in Quantity Type dropdown.

Race Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Therapeutic Details>>Expand Toggle menu, click Indications >>Click + Indications>>Add data>>Click Specifics tab>> Click +Specifics, the data will be available in Race dropdown.

Sponsor Type Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Select Products checkbox of Investigational Product Category and click Manage>> Click Protocol>>Click +Protocol, the data will be available in Sponsor Type dropdown.

Strength Quantity Unit Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Formulations>>Expand Toggle menu, click Composition >> Click + Composition>>Click Active Substances tab>>Click + Substance, the data will be available in Units dropdown for fields like ‘Numerator Lower Strength +Units, Numerator High Strength+ Units, High Strength Denominator +Units, Lower Strength Denominator+ Units ‘ etc.,

Study Type Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Select Products checkbox of Investigational Product Category and click Manage>> Click Protocol>>Click +Protocol, the data will be available in Study Type dropdown.

Symptom Condition Effect Classification Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Therapeutic Details>>Expand Toggle menu, click Undesirable Effects >>Click +Undesirable Effects >>Add data>>Click Undesirable Effects details tab>> Click +Undesirable Effects details, the data will be available in Symptom/Condition/Effect classification dropdown.

Registrations Section

Click on Registration link under toggle menu, user will be directed to multiple tabs. Activity Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Primary>> Click Status tab >>Click +Status, the data will be available in Activity dropdown.

Additional monitoring indicator To add the values in Additional monitoring indicator, following are the steps to follow: Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Secondary>> Click Monitoring tab, the data will be available in Additional monitoring indicator dropdown.

Applicant Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Secondary>> Click Application tab, the data will be available in Applicant dropdown.

Applicant Information Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Trademark, the data will be available in Applicant Information dropdown.

Application Category Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Applications>>Click +Application>>Select Products>>Click next, the data will be available in Application Category dropdown.

Application Stage Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Applications, the data will be available in Stage dropdown in the listing /grid.

Application Submission Format Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Applications>>Click +Application, Select Product>>Click Next button, the data will be available in Default Submission Format dropdown.
• Go to Submissions>>Click Sequence>> Click +Sequence, the data will be available in Submission Format dropdown

Application Submission Subtype Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Sequence>> Click +Sequence, the data will be available in Submission Subtype dropdown.

Application Submission Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Sequence>> Click +Sequence, the data will be available in Submission Type dropdown.

Application Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Applications>>Select a record and click Manage>>Basic info tab, the data will be available in Application Type dropdown.

ATC Name Note: The added data will be available in the application, following is the navigation:

• Submissions>>Registration>>Manage>>Primary>>Classification Tab>>the data will be available

Authorisation Status Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>xEVMPD >> Manage

Change Request Organization Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>> Registration>>Manage>>Secondary>>Marketing Status

Change Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Local Updates>>Click +Local Update>>Select Registrations>> Click Next button>>Enter mandatory data>>Click Save & Next button>>Click +Change, the data will be available in Change Type dropdown.
• Go to Submissions>>Click Global Updates>>Click +Global Update>>Select Registrations>> Click Next button>>Enter mandatory data>>Click Save & Next button>>Click +Change, the data will be available in Change Type dropdown.

Commitment Subtypes Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Commitments >> Click + Commitment, the data will be available in Commitment Subtype dropdown.

Commitment Types Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Commitments >> Click + Commitment, the data will be available in Commitment Type dropdown.

Communication Mode Note: The added data will be available in the application, following is the navigation:

• Submissions>>Products>>Manage>>Interactions>>Add or Manage Interactions>> You will find Communication Mode

CPP Application Status Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click CPPs, the data will be available in CPP Application Status Grid/listing.

CPP Existing Approval Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click CPPs>>Select a record and click Manage>>Product approval details, the data will be available in Existing Approval dropdown.

CPP Issuing HA Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click CPPs>>Click +Create CPP Request, the data will be available in CPP Issuing HA dropdown.

Currency Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Primary>> Click Payment Status tab >>Click + Payment Status, the data will be available in Amount +Currency dropdown.

CPP Status Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click CPPs>>Select a record and click Manage, the data will be available in CPP Request Status automatically data will be updated when CPP is created.

Dispensing Class Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Primary>>Click Product info tab, the data will be available in Dispensing Class dropdown.

Dosage Form Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Primary>> Click Product info tab, the data will be available in Administrable Dosage form dropdown.

Dossier Package Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Dossiers>>Select a record and click Manage>> Click Submission Packages – Central >> Enter mandatory data>>Click Can Support as Yes>> Select Upload from Existing Application radio button>>Click Browser Dossiers button, the data will be available in Select folder (Dossier Packages) dropdown.

Dossier Status Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Dossiers Module>>>>Add mandatory data in Dossiers module and save, the data will be available in Dossier grid, expand the grid records, Dossiers Status will be displayed.

EURD ID Note: The added data will be available in the application, following is the navigation:

• Submissions>>Registration>>Manage>>Secondary>>PV details

Geographic Area for Action Note: The added data will be available in the application, following is the navigation:

• Submissions>>Registration>>Manage>>Secondary>>Marketing Status

Goods And Services Information Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Trademark, the data will be available in Goods and Services Information dropdown.

Indicaton Type Note: The added data will be available in the application, following is the navigation:

• Submissions>>Products>>Registrations>>Manage>>Secondary>>Application>>Click on Orphan Drug Checkbox then Indication Type will appear.

Interaction Sub Type Note: The added data will be available in the application, following is the navigation:

• Submissions>>Products>>Interactions>>Add Interactions>>Interaction Sub Type
• Submissions>>Devices>> Interactions>>Add Interactions>>Interaction Sub Type
• Interactions>>Add Interactions>>Interaction Sub Type

Jurisdiction Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Secondary>> Click Marketing Validity tab, the data will be available in Country dropdown.

Legal basis Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Secondary>> Click Application tab, the data will be available in Legal basis dropdown.

Legal Grounds Note: The added data will be available in the application, following is the navigation:

• Submissions>>Registration>>Manage>>Secondary>>Marketing Status

Legal status of supply Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Secondary>> Click Monitoring tab, the data will be available in Legal status of supply dropdown.

Local Product Type Note: The added data will be available in the application, following is the navigation

• Submissions>>Registrations>>Manage>>Primary>>Product info

Local Update SubTypes Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Local Updates>>Click +Local Update>>Select Products, Country>> Click Checkbox and next button,, the data will be available in Local Update Sub Type dropdown.

Local Update Types Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Local Updates>>Click +Local Update>>Select Products, Country>> Click Checkbox and next button,, the data will be available in Local Update Type dropdown.
• Go to Submissions>>Click Local Updates>>Select a record and click Manage>> Click Basic Information tab, the data will be available in Local Update Type dropdown.

Marketing Status Note: The added data will be available in the application, following is the navigation:

• Submissions>>Registration>>Manage>>Secondary>>Marketing Status

Marketing Status Reason Note: The added data will be available in the application, following is the navigation:

• Submissions>>Registration>>Manage>>Secondary>>Marketing Status

Medicinal Product Category Note: The added data will be available in the application, following is the navigation Currently the Library is not in use MLF Code Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Secondary>> Click PV details tab, the data will be available in MFL Code dropdown.

Obligation Status Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Commitments >> Click + Commitment, the data will be available in Status dropdown.

Payment Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Primary>> Click Payment Status tab >>Click + Payment Status, the data will be available in Payment Type dropdown.

Product cross-reference type Note: The added data will be available in the application, following is the navigation:

• Submissions>>Products>>Registrations>>Secondary>>Applications>> Product cross-reference type

Query Categories Note: The added data will be available in the application, following is the navigation: Submission>>>Products and Devices>>>Interactions, Commitments, Obligations>>>Category Recurrence Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Commitments >> Click + Commitment, the data will be available in Recurrence dropdown.

Registration Obligation Sub Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Obligations>> Click +Obligation, the data will be available in Select Obligation Sub Type dropdown.

Registration Obligation Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Obligations>> Click +Obligation, the data will be available in Select Obligation Type dropdown.

Regulatory Authorization Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click secondary>>, the data will be available in Regulatory Authorization type dropdown.

Response Mode The added data will be available in the application, following is the navigation:

• Submissions>>Products>>Interactions>>Manage>> Response Mode
• Submissions>>Devices>>Interactions>>Manage>> Response Mode

Response Type The added data will be available in the application, following is the navigation:

• Submissions>>Products>>Interactions>>Manage>> Response Type
• Submissions>>Devices>>Interactions>>Manage>> Response Type

Risk of Supply Shortage Note: The added data will be available in the application, following is the navigation:

• Submissions>>Registration>>Manage>>Secondary>>Marketing Status

Route of Admin Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Primary>> Click Root of Admin tab, the data will be available in Route of Admin dropdown.

Safety Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Local Updates>>Click +Local Update>>Filter and select Registration>> Click Next button>>Select Local Update Type as Safety from dropdown, the data will be available in Safety dropdown.
• Go to Submissions>>Click Global Updates>>Click + Global Update>>Filter and select Registration>>click Next button>>Select Global Update Type as Safety from dropdown, the data will be available in Safety dropdown.

Safety Monitoring Note: The added data will be available in the application, following is the navigation

• Submissions>>Registrations>>Manage>>Primary>>Product info

Schedule Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Commitments >> Click + Commitment, the data will be available in Schedule dropdown.

Sequence HA Approval Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Sequences>>Select a record and click Manage>> Click Approval Details tab >>Select HA Response Received as yes>>Enter Received Date>> Select Application Approved? As Yes, the data will be available in Sequence HA Decision dropdown.

Sequence Status Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Dossiers Module, the data will be available in Dossier grid, expand the grid records, Sequence Status will be displayed. The created Sequence record will be displayed in Dossier module along with status.

Current Status Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Primary>> Click Payment Status tab >>Click + Payment Status, the data will be available in Status dropdown.

Contact Role Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Primary>> Click Payment Status tab >>Click + Payment Status, the data will be available in Status dropdown.

Submit To Note: The added data will be available in the application, following is the navigation:

• Submissions>>Products>>Applications>>Manage>>Application Details>>Basic Info>>Submit To
• Note: Submit To appears only when Application Category selected as Investigational

System Note: The added data will be available in the application, following is the navigation:

• Submissions>>Products>>Registration>>Manage>>Primary>>Classification>>Add Classification>>System

Task Status Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Obligations>> Click +Obligation>>Add data>>Click +Task, the data will be available in Status dropdown.

Task Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Commitments >> Click + Commitment>>Add data>>Click +Task, the data will be available in Task Type dropdown.

Trademark Address Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Trademark, the data will be available in Address dropdown.

Trademark Status Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Trademark, the data will be available in Status dropdown.

Translation Name Type Note: The added data will be available in the application, following is the navigation:

• Go to Admin settings>>Click Library>>Select substance collection>> Click +Additional Details for a substance which is checked as Active ingredient , the data will be available in Name Type dropdown.

Type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Secondary>> Click Application tab, the data will be available in Type dropdown.

Type Of Trademark Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Trademark, the data will be available in Type Of Trademark dropdown.

Wave Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Applications>>Select group application Id>>Click Manage>>go to Countries >>Select the checkbox>>Click Change Wave button, the data will be available in Wave dropdown.

xEVMPD Medicinal Product type Note: The added data will be available in the application, following is the navigation:

• Go to Submissions>>Click Registrations>>Select a record and click Manage>> Click Secondary>> Click Application tab, the data will be available in Medicinal Product type dropdown.

xEVMPD Operation Type Note: The added data will be available in the application, following is the navigation

• Submissions>>xEVMPD>>xEVMPD Submissions>>Operations

xEVMPD Status Note: The added data will be available in the application, following is the navigation

• Submissions>>xEVMPD>>xEVMPD manage>>

Substances Section

Click on Substances link under toggle menu, user will be directed to multiple tabs. Authorities Note: The added data will be available in the application, following is the navigation:

• Substances>>Applications>>Create Application>> Step-2: Choose Countries>>Authorities will appear.

Code System Note: The added data will be available in the application, following is the navigation:

• Go to Library >>Expand Toggle menu, click Substance Collection>> Click +Substance, the data will be available in Substance Code System dropdown.

Grade Note: The added data will be available in the application, following is the navigation:

• Substances>>Master File>>Add Substance>>Grade

Official Name Status Note: The added data will be available in the application, following is the navigation:

• Go to Library >>Expand Toggle menu, click Substance Collection>> Click +Substance>>Select Substance Name Type as Official, the data will be available in Official Name Status dropdown.

Official Name Type Note: The added data will be available in the application, following is the navigation:

• Go to Library >>Expand Toggle menu, click Substance Collection>> Click +Substance>>Select Substance Name Type as Official, the data will be available in Official Name Type dropdown.

Substance Application Type Note: The added data will be available in the application, following is the navigation: Substance>>>Applications>>>Create applications and Manage appplication Substance Name Type Note: The added data will be available in the application, following is the navigation:

• Go to Library >>Expand Toggle menu, click Substance Collection>> Click +Substance, the data will be available in Substance Name Type dropdown.

Substance Type Note: The added data will be available in the application, following is the navigation:

• Go to Library >>Expand Toggle menu, click Substance Collection>> Click +Substance, the data will be available in Substance Type dropdown.

Translation Name Type Note: The added data will be available in the application, following is the navigation:

• Library >>Expand Toggle menu, click Substance Collection>> Click +Substance >> check as Active ingredient>>Additional Details >>Add Translation Type dropdown.

MedDRA Section

Click on MedDRA link under toggle menu, user will be directed to the MedDRA page. Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Therapeutic Details>>Expand Toggle menu, click Indications >>Click + Indications>>Add data>>Click Indication details tab>> Click + Indication details, and also the data will be available in sections ‘Indications, Contraindications, Undesirable Effects, Interactions’ or where ever MedDRA is applicable.

Organization Collection Section

Click on Organization Collection link under toggle menu, user will be directed to the Organization page as shown in the below screen.

1. : Organization Details Table

To add the values in Organization Collection, following are the steps to follow:

• • 1. Click on ‘+Organization’, following screen is displayed.

1. : Add Organization Details
2. Enter the data in mandatory fields and click on Save button.

Note: The added data will be available in the application, following is the navigation:

• Add Organization as Distribution, enter mandatory data and save.
• Go to Products>>Manage>> Click Organization(s)>>Expand Toggle menu, click Distributor >> Click + Distributor>>Select name from the dropdown list, the data will be available in on the screen.

1. Click Edit, enter the data and click Save button, date will be updated.
2. Click Disable button to remove the record.
3. When Disable button is clicked, an alert message will display with OK and Cancel buttons.
4. Click OK button, the added record will be Disabled from the listing and the Disabled record will be moved to Disabled list.
5. To view the Disabled record, click ‘Show Disabled Records’ check box, the records will populate in the listing.
6. Click Audit button, a popup will display to view all the audit data.
7. Click Filter icon on the listing/grid, the filter options will display to filter the values in the listing.

Note:

• When the button is clicked the changes will be discarded.
• When the Clear button is clicked, the selected data will be cleared.
• When the Close button is clicked, the popup will be closed.

Substance Collection Section

Click on Substance Collection link under toggle menu, user will be directed to the Substance Collection page as shown in the below screen.

1. : Substance Details Table

To add the values in Substance Collection, following are the steps to follow:

1. Click on ‘+Substance’

Enter the data in mandatory fields and click on save button.

1. Repeat the above steps to add multiple rows.

Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Manage>> Click Formulations>>Expand Toggle menu, click Composition >> Click + Composition>>Click Excipients tab, the data will be available in Substance Name dropdown.

1. Click Edit, enter the data, and click Save button, date will be updated.
2. Click Disable button to remove the record.
3. When Disable button is clicked, an alert message will display with OK and Cancel buttons.
4. Click OK button, the added record will be Disabled from the listing and the Disabled record will be moved to Disabled list.
5. To view the Disabled record, click ‘Show Disabled Records’ check box, the records will populate in the listing.
6. Click Audit button, a popup will display to view all the audit data.
7. Click Filter icon on the listing/grid, the filter options will display to filter the values in the listing.

Note:

• When the button is clicked the changes will be discarded.
• When the Clear button is clicked, the selected data will be cleared.
• When the Close button is clicked, the popup will be closed.

Person Library Section

Click on Person Library link under toggle menu, user will be directed to the Person Library page as shown in the below screen.

1. : Person Library Details

To add the values in Person Library, following are the steps to follow:

1. Click on ‘+Person Library, following screen is displayed.

1. : Add Person Library
2. Enter the data in mandatory fields and click on Save button.
3. Repeat the above steps to add multiple rows.

Note: The added data will be available in the application, following is the navigation:

• Go to Library >>Expand Toggle menu, click Users>> Click +New User, the Email id will be available in Person Library dropdown, select the email id to view details.

1. Click Edit, enter the data, and click Save button, date will be updated.
2. Click Disable button to remove the record.
3. When Disable button is clicked, an alert message will display with OK and Cancel buttons.
4. Click OK button, the added record will be Disabled from the listing and the Disabled record will be moved to Disabled list.
5. To view the Disabled record, click ‘Show Disabled Records’ check box, the records will populate in the listing.
6. Click Audit button, a popup will display to view all the audit data.
7. Click Filter icon on the listing/grid, the filter options will display to filter the values in the listing.

Note:

• When the button is clicked the changes will be discarded.
• When the Clear button is clicked, the selected data will be cleared.
• When the Close button is clicked, the popup will be closed.

Product Family Collection Section

Click on Product Family Collection link under toggle menu, user will be directed to the Product Family Collection page as shown in the below screen.

1. : Product Family Collection Details

To add the values in Product Family Collection, following are the steps to follow:

1. Click on ‘+Product Family, following screen is displayed.

1. : Add Product Family
2. Enter the data in mandatory fields and click on save button.
3. Repeat the above steps to add multiple rows.

Note: The added data will be available in the application, following is the navigation:

• Go to Products>>Click +Products, the data will be available when Product Family is selected from the dropdown then Active Ingredient data will be auto populated.

1. Click Edit, enter the data, and click Save button, date will be updated.
2. Click Disable button to remove the record.
3. When Disable button is clicked, an alert message will display with OK and Cancel buttons.
4. Click OK button, the added record will be Disabled from the listing and the Disabled record will be moved to Disabled list.
5. To view the Disabled record, click ‘Show Disabled Records’ check box, the records will populate in the listing.
6. Click Audit button, a popup will display to view all the audit data.
7. Click Filter icon on the listing/grid, the filter options will display to filter the values in the listing.

Note:

• When the button is clicked the changes will be discarded.
• When the Clear button is clicked, the selected data will be cleared.
• When the Close button is clicked, the popup will be closed.

Library Mappings

Click on Library Mappings link under toggle menu, user will be directed to the Library Mappings page as shown in the below screen.

1. : Library Mappings Table

To add the values in Library Mappings under Country Group and Document Class Type, following are the steps:

1. Click on ‘+Country Group’ and ‘+Document Class type’, following screen is displayed.

1. : Add Mapping
2. Enter the data in mandatory fields and click on save button.
3. Based on the Country Group, Country, Class, Type the mapping will be created.
4. Repeat the above steps to add multiple rows.
5. Click Edit, enter the data, and click Save button, date will be updated.
6. Click Disable button to remove the record.
7. When Disable button is clicked, an alert message will display with OK and Cancel buttons.
8. Click OK button, the added record will be Disabled from the listing and the Disabled record will be moved to Disabled list.
9. To view the Disabled record, click ‘Show Disabled Records’ check box, the records will populate in the listing.
10. Click Filter icon on the listing/grid, the filter options will display to filter the values in the listing.

Note:

• When the button is clicked the changes will be discarded.
• When the Clear button is clicked, the selected data will be cleared.
• When the Close button is clicked, the popup will be closed.

Import Library Data

Click on the Import Library Data link under toggle menu, user will be directed to the Import Library Page as shown in below screen.

1. : Import Library Data

Here User can able to Import the data to different Librarys and Import Library Log Activity 1. Click on “Download the Template (icon)” user can be able to download the Template Headers without any data. 2. Click on “Download the Template With Existing Data (icon)” user can be able to download the existing data elements in the library with Headers. 3. Click on user can be able to browse and upload the Template with Required data. 4. After the successful upload user can be able to see the added data in “Import Libraries Log Activity”

1. Import Libraries log activity

Note: User should use the file “Download the Template (icon)” for importing the values .

Settings

User will have privilege to configure system settings. Click toggle menu, the Settings is divided into different sections as shown below:

1. General Settings
2. Preferences
3. Milestones
4. Notification Templates
5. Affiliate
6. SPOR Logs

General Settings

The General Settings page will be displayed by default when Settings tab is clicked. User can configure Password setting for the SPAR application and other general settings as shown in the below screen.

1. : Configure General Settings

The following information will be displayed in the General Settings:

• Password Expiry Days: Number of days before passwords expires.
• Password Change Notification: Number of days before user will be notified about expiration.
• Minimum Password Failed Attempts: Number of password attempts a user will be allowed while logging in.
• Password Required Length: Length of the Passsword
• Password History Limit: Number of Password History limit
• Date Format: Format of date in YY-MM-DD
• Theme : Theme Colour of the Application (Blue / Orange)
• Session Time out (In Mins): Time limit for session
• Required Special Characters Check box: Number of Special Characters in Password.
• Required Numeric Characters Check box: Number of Numeric Characters in Password.
• Required Uppercase Characters Check box: Number of Uppercase Characters in Password.
• Required Lowercase Characters Check box: Number of Lowercase Characters in Password.
• Show Internal Id Check box: if checkbox is checked then Internal Id in the listing/grid’s will be displayed. If unchecked Internal Id column in listing will be invisible.

The following information will be displayed in the Documentum Settings

• Documentum UserName: UserName of the Documentum Login
• Documentum Password: Password of the Documentum Login
• Documentum Repository: Details of Documentum Repository
• Documents Upload Type: Document Upload Types

By default specific values are preconfigured in the application, however these can be modified as per the requirement.

1. Enter values in mandatory field and click Save button to configure the password settings.
2. Click Default Values button to revert the application to its default settings.
3. Click Audit button, a popup will display to view all the audit data.

Preferences

Click on Prefrences link in the settings, user will be directed to the below screen.

1. : Configure Preferences

User can configure the following settings for SPAR application here:

• HA Query due date Notification (Days)
• PSUR Submission Due date Notification (Days)
• Registration Renewal Due date Notification (Days)
• Commitment Due Date Notification (Days)
• Obligation Due Date Notification (Days)
• Workflow Process (No Review, First Level Review, Second Level Review)

By default certain values are provide in the application, however these can be changed to suit your requirements.

1. Enter values in each field and click Save button.
2. Click Default Values button to revert the application to its default settings.
3. Click Audit button, to view every action in audit history popup.

Milestones

User can create Milestones for Applications, Registraions and Local updates modules. Based on the created Milestone template and its criteria, ‘Select other templates’ in Applications ‘Status’ tab, Registraions ‘Status’ tab and Local updates ‘Status’ tab will display from Milestones if criteria and Milestone details matches. Click on Milestones link in the settings dropdown, user will be directed to the below screen.

1. : Configure Milestones

To add the values in Milestones, below are the steps to follow:

1. Click ‘+Milestone’.

1. : Add Milestones
2. Enter the mandatory data and click on Save button.
3. Go to Milestone listing/grid. Select a record and click Manage button, the following tabs will be displayed:

• Basic Info
• Criteria
• Milestones

1. Enter/Select values in each field in Basic info tab and click Save button.

1. : Milestones-Basic Info Tab
2. Enter/Select values in each field in Criteria tab and click Save button.

1. : Milestones-Criteria Tab

To add the values in Milestones, follow the below steps:

1. : Milestones-Milestones Tab
2. Click ‘+Add’ button.

1. : Milestones-Add Page
2. Enter values in each field in Milestones tab and click Save button.
3. Under Actions, click Edit button, enter the data, and click Save button, date will be updated.
4. Under Actions, click Delete button to remove the record.
5. When Delete button is clicked, an alert message will display with OK and Cancel buttons.
6. Click OK button, the added record will be Deleted from the listing
7. Click Audit button, a popup will display to view all the audit data.
8. Go to Milestone listing/grid, Click Delete button under Actions to delete the record.
9. Go to Milestone listing/grid, Click Audit button under Actions to view the audit information.
10. Go to Milestone listing/grid, Click Copy/Clone to copy the record into the listing.
11. Click Filter icon on the listing/grid, the filter options will display to filter the values in the listing.

Note: The added data will be available in the application, following is the navigation:

• Go Submissions>> click Application >>Manage Application>>Go to application details, data will be available in the status tab.
• Go Submissions>> click Registration >>Manage Registrations>> Status tab, data will be available in the status tab.
• Go Submissions>> click Local updates >>Manage local updates>>Go to Submission Status, data will be available in the status tab.

Notification Templates

User can create a Notification Template based on the Module selection like Obligation, Commitments etc.,. By selecting the Manage Notification, user can add Basic info, criteria and Recipients. Based on the Notification templete details, a pre-defined email will be triggred to the user at entered Trigger Time. Click on Notification Templates user will be directed to the below screen.

1. : Configure Notification Templates

To add the values in Notification Template, below are the steps to follow:

1. Click ‘+Notification Template’, enter values in each field and click Save button.

1. : Add Notification Template
2. Go to Notification listing/grid. Select a record and click Manage button, the following tabs will be displayed:

• Basic Info
• Criteria
• Recipients

1. Enter values in each field in Basic info tab and click Save button.

1. : Notification Templates-Basic Info Tab
2. Enter values in each field in Criteria tab and click Save button.

1. : Notification Templates -Criteria Tab

To add the values in Criteria, follow the below steps:

1. Click ‘+Add’ button.
2. Enter values in each mandatory field in Criteria tab and click Save button.

Note: Criteria tab allows user to define One time and recurring notifications One time – Notifications trigger to the recipeints only once based on the action Recurring – Notfications trigger to the recipients multiple times based on given freequency. Example :Recurring frequency email no is 2 then it will divide the span of days between date of notification template creation and due date by freequecy of email= x , so for every x day, system will generate a email.

1. Under Actions, click Edit, enter the data, and click Save button, date will be updated.
2. Under Actions, click Delete button to delete the record.
3. When Delete button is clicked, an alert message will display with OK and Cancel buttons.
4. Click OK button, the added record will be Delete from the listing.
5. Click Audit button, a popup will display to view all the audit data.
6. Click Filter icon on the listing/grid, the filter options will display to filter the values in the listing.
7. Enter values in each field in Recipents tab and click Save button.

1. : Notification Templates – Recipients Tab
2. Go to Notification template listing/grid, Click Delete button under Actions to delete the record.
3. Go to Notification template listing/grid, Click Audit button under Actions to view the audit information.
4. Go to Notification template listing/grid, Click Copy/Clone to copy the record into the listing.
5. Click Filter icon on the listing/grid, the filter options will display to filter the values in the listing.

Note: The added data will be available in the application, following is the navigation:

• Go Submissions>> click Application >>Manage Application>>Go to application details, data will be available in the status tab.
• Go Submissions>> click Registration >>Manage Registrations>> Primary tab, data will be available in the status tab.
• Go Submissions>> click Local updates >>Manage local updates>>Go to Submissions, data will be available in the status tab.

Affiliate

This section will help user to create Affiliate in the application. To create the Application, follow the below steps

1. : Affiliates Grid
2. Click On +Affiliate
3. Give additional description
4. Click on Save.
5. When Active button is clicked under Status, an alert message will display with OK and Cancel buttons.
6. Click OK button, the record will be Deactivated in the listing.
7. When Deactive button is clicked under Status, an alert message will display with OK and Cancel buttons.
8. Click OK button, the record will be Activated in the listing.
9. Click Edit icon, enter the data, and click Save button, date will be updated.
10. Click Audit History icon, to view every action in audit history popup.
11. Enter data in Search field to retrieve the data from the grid.

SPOR Logs

This feature enables user to monitor the Logs about SPOR data in the Application.

1. : SPOR Log Report
2. Enter data in Search field to retrieve the data from the grid.

Assigned to

Assigned to allows user to coordinate with his/her team to ensure accuracy in data. Three prominent tasks have been considered:

• Draft
• Review
• Approve

Status Specification

Based on these tasks, following statuses have been defined:

1. User can perform ‘Assigned to’ in the application for Products, Applications, Seqeneces, Dossiers , Registarions, Global Updates
2. Goto listing page for the above modules.
3. The column will display icons which the status of the record will display. Following icons will be available in the application:
   1. In – Progress (Draft icon); when data entry is in progress.
   2. Reviewed ; Record has been reviewed and is good to go.
   3. For Approval ; Record is assigned for Approval, but the process has not yet begun.
   4. For Review ; Record is assigned for review, but the review has not yet begun.
   5. Approved – Approved records.
   6. Review Revert/Approve Revert icon for Reverted records – Not a true “status”
4. When a User creates Products, Applications, Sequences, Dossiers, Registrations, Global Updates a record(s) will be created in the respective listing; the status will be captured as “In-Progress”.
5. When the Business user or privileged user assigns reviewers to a record for review; the status will be captured as “For Review”
6. When two or more reviewers are assigned a record, even if one reviewer reverts the record, “Review Revert icon” will be captured in the status.
7. If one of the reviewers in the review cycle select “Reviewed”, then the status of the record will show as “Reviewed”. Same applies for approvers.
8. When the Business user or privileged user assigns an Approver to a record for review; the status will be captured as “For Approval.”
9. The status of the record will be changed to “Approved” when the Approver selects Approved and signs the e-signature.
10. If Approver selects “Revert”, then “Approve Revert icon” will be captured in the status.

Marking a Record

User can enter Draft details in Products /Applications/ / Sequences /Dossiers /Registrations / Global Updates records. On Products page in the tool, user will find a small icon, on top right. For example: Go to Products>> Select the record from the listing>> Click Manage button, the icon will display on the top right of the page. Once user complete entering the data for a Product record, click the icon. You will see the comments pane. The following actions can be performed in the comments pane:

1. Enter the comments in the space provided and click ‘Add Comment’. You will see your comments with your name and the role similar to the Figure.

1. : Comments Screen
2. If the record has been sent back to user by a reviewer, user can always see the reviewer’s comments using the comments pane. The checkboxes given under Comments Heading will let user filter between the comments.
   1. Check Draft, user will see all comments by Data Users.
   2. Check Review, user will see all comments by Reviewers.
   3. Check Approve, user will see all comments by Approvers.
3. Once user or team mates have finished entering data for this product,click Add Comment button.
4. The comments will be added to the Inprogress record.

For Products/Applications/ Registrations/ Sequences /Dossiers / Global updates records, below is the process:

1. Go- to Products/ Applications/ Sequences /Dossiers /Registrations/ Global Updates listing.
2. Select a record that shows ‘ In progress as a Status.
3. Select button on the top of the table
4. Click Assigned to, the page will be directed to the following screen.

The Assigned to Page has following features:

1. Select Mode: User can choose to put the record through for Draft (Data-entry), Review, or Approve using the radio buttons.
2. Select Users: Select the users to assign the record to review/approve.
3. Date: Select the expected date that user must complete his/her work on the record.
4. Comments Pane:
   1. Section – User can view the Sequence details in Application module or Product name user selected in Products module etc.,
   2. User can view comments from all users for the product and add comments if any.
5. By default Select mode-Draft will be selected

1. : Application Assigned To Screen
2. Enter the ‘Draft Comments’ and click on ‘Add Comments’ button.
3. The comments will be added to the record.

Assigning a record for a required action

Business Administrator user can assign a record to users having privileges of Reviewer and approvers. Go to the Products /Applications/ / Sequences /Dossiers / Registrations /Global updates

1. Select a record that shows ‘ In progress as a Status. user will see button under Actions menu.
2. Click icon, the page will be directed to the following screen.

1. : Assigned to Screen
2. Select Review radio button and select Users from the list.
3. Enter date and click on Save button.
4. User can view the selected product in the ‘Select Product’ section dropdown.
5. Add relevant comments if needed.
6. Click Add Comments button.
7. By selecting the Save button again user can unassigned all reviewers if needed.
8. If two reviewers are added in the ‘Select Users’ list then all the two reviewers have to complete the work flow to go to Approve step.
9. The status of the record will change to ‘For Review’ in the listing.

Note: You can assign multiple records to the same set of users for an action. For Example, user can assign 5 records to three reviewers for Review. An email will be triggered to the assigned user for the required action.

Reviewing a Record

The assigned Business Admin user or a Reviewer can review the record . Below are the steps to follow to review a record:

1. Select a record that shows ‘For Review’ as a Status. User will see button under Actions .
2. Click icon, the page will be directed to the following screen.

The Review Page has following features:

• 1. The first section of the screen contains the product details.
  2. The tree view on the left lets user scroll to the required section that user want to review.
  3. User can choose a product for review from the dropdown above the navigation pane/tree view.

1. : Review Screen For Products

1. :Review Screen For Global Updates
   1. ‘Comments’ section is available to add comments as reviewer.
   2. The button with a down arrow allows user to expand and view details under the heading.
   3. User can export this record to PDF using the Export to PDF option and print the product information for perusal.
2. Once user have reviewed the record, user can add the comments and mark the record as review complete, as explained below.

Notes:

• Only the assigned user should be able to review the record, hence review button is enabled only for the assigned user and is disabled for Author and Other Users.

Marking a Record as ‘Review Complete’

Once user complete reviewing a Product record, click the comments icon. You will see the comments pane. You can do the following things in the comments pane:

1. Enter your comments in the space provided and click ‘Add Comment’. You will see your comments with your name and your role.
2. There will be two options below the comments pane; Review complete / Reviewed and Revert.

1. : Marking A Record As ‘Review Complete’
2. If the record doesn’t need any changes, user can put it for approval. Select Review complete using the radio button and click Submit.
3. The status of the record will be changed to ‘For Approval’ & an email will be triggered to the assigned user.
4. If some changes need to be made, user can either make them yourself using the Manage button for that product or user can revert the record to the respective user.
5. To revert the record, select the Revert option using a radio button and click submit.
6. The record will show icon in the Status column. This signals the Business administrator that this record will be reverted to the Work flow users.

Notes:

• When the record is Reviewed, Review option is disabled for all the users.

Approving a Record

User can approve a record as a Business Administrator user or an Approver:

1. Select a record that shows ‘For Approval’ as a Status, user will see button Under “Actions”.

1. : Approver’s Screen
2. Click Approve button, user will be directed to the screen as shown in Figure:
   1. The first section of the screen contains the product details.
   2. The navigation pane to the left lets user scroll to the required section that user want to review.
   3. User can choose a product to approve from the dropdown above the navigation pane.
3. Once user complete reviewing a Product record, click the comments icon. You will see the comments pane.
4. Enter your comments in the space provided and click ‘Add Comment’. You will see your comments with your name and your role.
5. There will be two options below the comments pane; Approved and Revert.
6. If the record doesn’t need any changes, user can Approve it. Select Approved using the radio button and click Submit.
7. You will see an Electronic Signature pop up as illustrated in Figure

1. : E-Signature Pop-Up
2. Enter the Password and the Reason and click Submit
3. The Record will be marked as Approved & an Email Notification will be sent to the concerned users.
4. If some changes need to be made or if it the record needs another review, user can revert the record to the Reviewers.
5. To revert the record, select the Revert option using a radio button and click submit.
6. The record will show icon in the Status column. This signals the Admin that this record will be reverted to the Reviewers.

Notes:

• Only the assigned user should be able to Approve the record, hence approve button is enabled only for the assigned user and is disabled for Author and Other Users.
• When the record is approved, approve option is disabled for all the users.

General Functions

Grid Function

The following are the common listing/grid functions in entire application.

1. Filter:

Filters help the user to retrieve the necessary information.

1. Click Filter icon on the listing/grid, the filter option will display as shown below.

1. Following conditions will be displayed to filter the values in the listing.

• Is equal to
• Is not equal to
• Starts with
• Contains
• Does not contain
• Ends with

1. For example, user can filter as shown below:

1. : Filter option
2. Click column heading Filter icon. Here, Name filter icon is clicked as an example.
3. Select condition ‘Starts with’ and enter word ‘INCH’.
4. Select ‘And’ operator.
5. Select condition ‘Contains’ and enter letter ‘CH’
6. The Name INCH will display in the grid as shown below.

1. :Filtered data in listing

Note:

• When the Clear button is clicked, the selected data will be cleared.

Sorting: User can sort the grid columns in ascending/descending order.

1. Click on column heading, the sort icon will appear to view column values in ascending order.
2. Click sort icon to view column values in descending order.
3. Click expand icon to view the child row(s) in the listing as shown below.

1. : Expanded view

Page Navigation:

1. Click numbers 1,2,3 etc., to view the records in next page.
2. Click page navigation left icon to go to first page.
3. Click less than icon to go to previous page.
4. Click greater than icon to go to next page.
5. Click page navigation right icon to go to last page.

1. : Page navigation
2. Click items per page as 10 then 10 records will display in the grid. User can select 5, 10, 20 and 50 records per page.
3. The count will be displayed on the right side of the grid, example., 1-5 of 23 items. The count will change based on items per page selection.

Favorite’s Listing

The Icon shows the records which are marked as favorite in the listing for modules Products / Applications / Sequences / Dossiers / Registrations / Global Updates / Local Updates / CPP Requests. To add the a record in Favorite View:

1. Click on the favorite icon in the listing.
2. Click on on top of the grid.
3. The selected favortie record will be displayed in My Favorites tab.

1. Favorites button

View button in grid.

Click “View” button on the “Products/Devices/Document/Applications/Sequences/ Dossiers/ Registrations/ Interactions/ Global Updates/ Local Updates/ xEVMPD>XEVMPD Submissions/ CPPs/ Substances” home page. Page will be redirected to the view page.

1. : View button in Product Grid
2. If you see Dropdown on left pane, select Dropdown(s), the drop down list will display with appropriate Name. Upon selecting the dropdown in the tree view, User must view the details in the left side pane.

1. : View screen in Applications
2. Click link in the left side pane form the tree view, related data will populate in the right side pane.
3. Click ‘Export to PDF’ button to export the data.

1. : View Page – Product

Include Inactives Listing

User can view inactive records in the listing for the modules Devices / Applications / Registrations / Interactions Commitments / Obligations / Global Updates / Local Updates.

1. Select ‘Include Inactive’ or ‘inactive’ check box to view inactive records as shown below.
2. The inactive record row will be displayed in the grid.
3. : Inactive Product records Listing

1. : Inactive Local Updates records Listing

Edit a Record

1. Most pages will have an Edit button
2. Click the Edit button.
3. Make the necessary changes in the information and click ‘Save’ button to save the changes made to the record.

Note: The below screen is from Devices >>Actions>Edit.

1. : Edit Screen

Disable a Record

1. Most pages will have a Disable button
2. Click the ‘Disable’ button.
3. A pop up will appear, confirming if user want to Disable the item.
4. Click Ok, and the record is Disabled from the system.

Note: You will not be able to Disable a Product record once it has been approved by an approver.

1. : Disable Screen

14.7. Cancel a Record

1. Most pages will have an ‘Cancel’ button
2. Click the Cancel button.
3. The page will exit without saving the information.

1. : Cancel button Screen

Reset Page

1. Most pages will have an ‘Reset’ button
2. Click the Reset button.
3. The Reset button lets user clear the information user just entered respectively.

1. : Reset button Screen

Audit History

1. Most pages will have an ‘Audit button either under Actions or on the page as icon.
2. Click the Audit button.
3. A popup will display in view mode with all the audit data of that particular section or module.

1. : Audit popup Screen

Map to Affiliates

Map to Affiliate will add / map the particular record (Document only) to that Affiliate / Organization. To Map a Record, follow the below steps: 1. Select the Required Record(s) & Click on Actions >> Map to Affiliate

1. : Map to Affiliate Button

2. Affiliate Popup will display the available Affiliates in the application

1. : Affiliate Pop Up

3. By default already mapped Affiliate will be in Disabled mode. 4. Select the Required Affiliate and Click on Map.

IDMP and XEVMPD identifiers

The IDMP and XEVMPD field will display with red or green colour. The ‘I’ super script for the field indicates IDMP field and ‘X’ super script for the field indicates XEVMPD field. Below are the IDMP identifiers which are marked beside relevant fields.

• Mandatory – I*
• Optional – I^o
• Conditional – I^c
• Mandatory Optional – I^{* o}

1. : IDMP fields from Add Products

Below are the XEVMPD identifiers which are marked beside relevant fields.

• Mandatory – X*
• Optional – X^o
• Conditional – X^c
• Mandatory Optional – X^{* o}

1. : XEVMPD fields from Manage Registrations

Exporting a report

For all the reports users have an option to export it in terms of “excel” and “PDF”.

1. Export options

Export to PDF

Once the user clicks on “Export to PDF” as shown in figure -509, the below screen will follow , which will allow to select the size of PDF export to. By default A3 size would be selected as shown in figure -510 Note: Incase user have difficulty reading the report after printing , they can change the PDF size to A2 or A1 .

1. Default size for Export to PDF

To download the report , user needs to have appropriate role assigned then have to follow the below steps 1. click on “Export to PDF” 2. select “PDF size” 3. Click on “Export”

1. Sample PDF report

Reading a help text

Help texts are available for the field attributers as shown below figure with a “?” mark. Once user clicks the same a pop up will show some info about the field. These kind of help texts are available throughout the application for the important and key terms.

1. Help Text

Glossary

Ack	acknowledgement; usually an electronic acknowledgment of a successful submission
ADR	adverse drug reaction; unintentional and harmful response to a medicine
AE	Adverse event: Any untoward medical occurrence that may present during treatment with a pharmaceutical product, but which does not necessarily have a causal relationship with this treatment.
AF	application form; module 1.2 of the EU CTD.
AGES	Austrian Agency for Health and Food Safety; provide professional and independent scientific expertise related to public health, animal health, food safety, medical and drug safety, food security and consumer protection in Austria
AIFA	Agenzia Italiana del Farmaco (Italian Medicines Agency); is the national competent authority responsible for drugs regulation in Italy
AL	administrative & legal
ANSM	Agence nationale de sécurité du médicament et des produits de santé (French Medicines Agency); the competent authority that oversees the quality, safety, and efficacy of pharmaceuticals and medical devices in France
API	Active pharmaceutical ingredient: An active ingredient is the ingredient in a pharmaceutical drug or pesticide that is biologically active
App	Application
AR	adverse reaction; see ADR
AR	assessment report: A set of documents describing the evaluation of a medicine authorised via the centralised procedure and including the product information, published on the European Medicines Agency website. European public assessment reports include the product information.
ASMF	Active Substance Master File: An Active Substance Master File (ASMF), or formerly known as European Drug Master File (EDMF) procedure, is a set of documents that protects the valuable confidential intellectual property of the manufacturer.
ASR	annual safety report; An annual summary of all serious adverse events for an active compound in clinical evaluation with a safety evaluation relating to the ongoing study (ies)
assess	assessment
ATC	Anatomical Therapeutic Chemical: a unique code assigned to a medicine according to the organ or system it works on and how it works. The classification system is maintained by the World Health Organization
BA	Bioavailability; is defined as the extent to which an active ingredient in a medicine is absorbed by the body
BE	bioequivalence; is when two medicines release the same active ingredient into the body at the same rate and to the same extent under similar conditions
BfArM	Bundesinstitut für Arzneimittel und Medisinprodukte (Federal Institute for Drugs and Medical Devices in Germany); is the competent authority in Germany that operates under the Federal Ministry of Health
BNF	British National Formulary: is a UK pharmaceutical reference book that contains a wide spectrum of information and advice on prescribing and pharmacology, along with specific facts and details about many medicines available on the UK National Health Service
BOS	break-out session; happens during a DCP/MRP/CP
BP	British Pharmacopoeia; is the national pharmacopoeia of the United Kingdom. It is an annual published collection of quality standards for UK medicinal substances. It is used by individuals and organizations involved in pharmaceutical research, development, manufacturing and testing
buc	Buccal
CA	competent authority; a medicines regulatory authority in the European Union
CAPA	Corrective Action Preventative Action: are improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations.
caps	Capsules
CCDS	company core data sheet
CCSI	company core safety information
CE	Conformité European (CE mark)
CEP	Certification of suitability to the Monographs of the European Pharmacopoeia The manufacturer of a substance will be able to provide proof that the quality of the substance is suitably controlled by the relevant monographs of the European Pharmacopoeia by means of a certificate of suitability granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM). This Certificate can be used in place of the entire module 3.2.s in the EU CTD
CESP	Common European Submission Platform: The purpose of the system is to: Provide a secure method of communicating with the Regulatory Agencies via one platform Allow submission of an application once to reach all required Agencies Reduce the burden for both Industry and Regulators of submitting/handling applications on CD-ROM and DVD
chew	Chewable
CHMP	Committee for Medicinal Products for Human Use; responsible for preparing the Agency’s opinions on questions concerning human medicine
CIOMS	Council for International Organizations of Medical Sciences; is an international nongovernmental organization established jointly by WHO and UNESCO in 1949 to serve the scientific interests of the international biomedical community in general and promulgate guidelines for the ethical conduct of research, among other activities
clin	Clinical
CMDh	Co-ordination group for Mutual recognition and Decentralised procedures – Human; responsible for the examination and coordination of questions relating to the marketing authorisation of human medicines in two or more Member States in accordance with the mutual recognition or decentralised procedure
CMDv	Co-ordination group for Mutual recognition and Decentralised procedures – Veterinary; responsible for the examination and coordination of questions relating to the marketing authorisation of veterinary medicines in two or more Member States in accordance with the mutual recognition or decentralised procedure
CMS	concerned Member State; a European Economic Area country in which an application has been submitted for authorisation of the medicine through the mutual recognition or decentralised procedure
commit	commitment/commit
COMP	Committee on Orphan Medicinal Products; responsible for reviewing applications for orphan designation for medicines that are intended for the diagnosis, prevention or treatment of rare diseases
CP	centralised procedure; European Union-wide procedure for the authorisation of medicines, where there is a single application, evaluation and authorisation throughout the European Union
CPD	continuing professional development
CTA	clinical trial application
CTD	common technical document/clinical trials directive
cut	Cutaneous
DCP	decentralised procedure; the procedure for authorising medicines in more than one European Union Member State in parallel
eCTD	electronic common technical document: an interface used by applicants of marketing authorisation for medical products to submit regulatory affairs document to the agency concerned
EDQM	European Directorate for the Quality of Medicines & Healthcare; a Directorate of the Council of Europe, committed to achieving harmonisation of the quality standards for safe medicines throughout the European continent and beyond
EEA	European Economic Area; is an area of free trade and free movement of peoples comprising the member states of the European Union, in addition to Norway, Iceland and Liechtenstein
eff	effervescent
EMA	European Medicines Agency; the main agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU
emul	emulsion
EOP	end of procedure
EP	European Pharmacopeia: a published collection of monographs which describe both the individual and general quality standards for ingredients, dosage forms, and methods of analysis for medicines
EudraVigilance	European Union Drug Regulating Authorities Pharmacovigilance; a data processing management system for reporting and evaluating suspected adverse drug reactions (ADRs) during the development and post marketing authorisation approval of medicinal products for human use in the European Economic Area (EEA)
EURD	EU reference dates
EVMPD	EudraVigilance Medicinal Product Dictionary; European Medicine Agency’s pharmacovigilance system
FAMHP	Federal Agency for Medicines and Health Products (of Belgium); responsible for the approval and registration of new medications in Belgium and for pharmacovigilance
FAQ	frequently asked question
fc tabs	film-coated tablets
FDA	Food and Drug Administration; Regulatory agency of the USA
gastres	gastro-resistant
GCP	good clinical practice; A code of international standards concerning the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials
gel	gel
GLP	good laboratory practice; a code standard concerning the testing of medicines in laboratories during their development
GMP	good manufacturing practice; a code standard concerning the manufacturing, processing, packing, release and holding of medicines
HA	Health Authority
HCP	Healthcare Professional
HMA	Heads of Medicines Agencies; the network of heads of the regulatory authorities responsible for the regulation of human and veterinary medicines in the EEA
hrdcaps	hard capsules
IB	investigational brochure
ICH	International Council on Harmonisation; bring together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration
ICSRs	individual case safety reports: A document providing information related to an individual case of a suspected side effect due to a medicine. ()
IDMP	identification of medicinal products; The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP)
IMP	investigational medicinal products; a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorised form”
imp	implementation
IMPD	Investigational Medicinal Product Dossier: is one of several pieces of Investigational Medicinal Product (IMP) related data required whenever the performance of a clinical trial is intended in one or more European Union Member States
info	information
infus	infusion
inh	inhalation
inj	injection
INN	international non-proprietary names; identify pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognised and is public property, also known as a generic name
ISO	International Organization for Standardisation; is an international standard-setting body composed of representatives from various national standards organizations
MA	marketing authorisation: the approval to market a medicine in one, several or all European Union Member States
MAA	marketing authorisation application: application made to a European regulatory authority for approval to market a medicine within the European Union
MAH	marketing authorisation holder: company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States
manuf	manufacture/manufacturer
MEB	Medicines Evaluation Board (Netherlands Medicines Agency); an independent authority that regulates the quality, efficacy and safety of medicines, and encourages better use of medicines for the right patient
med	medicinal/medical
MedDRA	Medical Dictionary for Regulatory Activities; is a clinically validated international medical terminology dictionary (and thesaurus) used by regulatory authorities in the pharmaceutical industry during the regulatory process, from pre-marketing to post-marketing activities, and for data entry, retrieval, evaluation, and presentation. In addition, it is the adverse event classification dictionary endorsed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
MHRA	Medicines and Healthcare products Regulatory Agency; is an executive agency of the Department of Health in the United Kingdom which is responsible for ensuring that medicines and medical devices meet applicable standards of safety, quality and efficacy
mr	modified release
MRP	mutual recognition procedure: a procedure through which an authorisation of a medicine in one European Union Member State is recognised by another Member State
MS	Member State
NCA	National Competent Authority; a medicines regulatory authority in a European Union Member State
NeeS	Non-eCTD electronic Submissions
notif	notification
NSAID	non-steroidal anti-inflammatory drug
NtA	notice to applicants; The body of European Union legislation in the pharmaceutical sector is compiled in Volume 1 and Volume 5 of the publication “The rules governing medicinal products in the European Union”
NUI	non urgent information
oint	ointment
OMS	organizations data management service
oral	oral
oro	orodispersible
OTC	over the counter
par	parenteral
PAR	public assessment report
PASS	post authorisation safety study
PBRERS	periodic benefit risk evaluation report
pess	pessary
Pharma	pharmaceuticals
PI	product information/principal investigator
PIL	patient information leaflet
PIP	paediatric investigation plan: a development plan aimed at ensuring that the necessary data are obtained to support the authorisation of a medicine for children, through studies in children
PMID	PubMed identifier is a unique integer value, starting at 1, assigned to each PubMed record; a PMID is not the same as a PMCID which is the identifier for all works published in the free-to-access PubMed Central
POA	power of attorney
POM	prescription only medicine
PPI	proton pump inhibitor
pr	prolonged release
PRAC	Pharmacovigilance Risk Assessment Committee; the European Medicines Agency’s (EMA) committee responsible for assessing and monitoring the safety of human medicines
prep	preparation
prod	product
PSMF	Pharmacovigilance System Master File
pste	paste
PSUR	periodic safety update report: a report prepared by the marketing-authorisation holder describing the worldwide safety experience with a medicine at a defined time after its authorisation
PSUSA	PSUR single assessment
PT	preferred term
	Also, Portugal
PUMA	paediatric-use marketing authorisation
PV	Pharmacovigilance; science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem
pwdr	powder
QA	quality assurance
QC	quality control
QMS	quality management system
QP	quality procedure/qualified person
QPPV	qualified person for pharmacovigilance
QRD	quality review of document; templates for product information, maintained by the EMA and updated regularly
RA	regulatory affairs
RAPS	Regulatory Affairs Professionals Society: is the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products
recd	received
ref	reference
reqd	required/requested
RMP	risk management plan; module 1.8.2 of the EU CTD
RMS	reference Member State; the European Union Member State that leads the review of an application in a mutual recognition procedure or decentralised procedure ()
	also, referentials data management service
RP	responsible person
RSI	reference safety information
RTQ	response to questions
Rx	prescription
SAE	serious adverse event
SAR	serious adverse reaction
SmPC/SPC	summary of product characteristics; a document describing the properties and the officially approved conditions of use of a medicine
SMQ	Standardised MedDRA Query
SOC	system organ class
soln	solution
SOP	standard operating procedure
SPOR	substance, product, organization and referential master data; The European Medicines Agency (EMA) is implementing the ISO IDMP standards for the identification of medicinal products in a phased programme, based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organization and referential (SPOR) data
spry	spray
SSRI	selective serotonin reuptake inhibitor
std	standard
sub	submission
supp	suppository
SUSAR	suspected unexpected serious adverse reaction
susp	suspension
tabs	tablets
transder	transdermal
USP	United States Pharmacopeia: is a pharmacopeia for the United States published annually by the United States Pharmacopeial Convention, a nonprofit organization that owns the trademark and copyright
v1/v2/v3	version
VAMF	vaccine antigen master file
VHP	voluntary harmonisation procedure; the organization of coordinated assessment of clinical trials by the CTFG
VMD	Veterinary Medicines Directorate: is an Executive Agency of the Department for Environment, Food and Rural Affairs (Defra) seeking to protect public health, animal health, the environment and promoting animal welfare by assuring the safety, quality and efficacy of veterinary medicines in the United Kingdom
Vol	volume
VSI	variation supplementary information
WHO	World Health Organization: is a specialised agency of the United Nations that is concerned with international public health
XEVMPD	Extended EudraVigilance Medicinal Product Dictionary
XEVPRM	eXtended Eudravigilance Medicinal Product Report Messages
XML	extensible markup language