Enable EMA Certification Enhancements (Name Parts and RoA Prioritization)

Learn how to update your Vault’s configuration to enable the enhancements for EMA E2B Certification.

About the Feature

Support for new Name Part fields was added in 21R2. Follow the configuration steps below to enable this feature within your Vault.

Add Name Part fields to Case Product Layouts

1. In the Admin area, go to Configuration > Objects > Case Product > Layouts.
2. Select Case Product Detail Page Layout.
3. In the Registration section, add the following fields:
   • Container Name Part
   • Device Name Part
   • Form Name Part
   • Invented Name Part
   • Scientific Name Part
   • Strength Name Part
   • Trademark Name Part
   • Intended Use Name
4. Select Save.
5. On the Layouts tab, repeat step 3 for any custom layouts you have.

Update the Case Drug History Object

Add Name Part Fields to Case Drug History Layout

1. Go to Configuration > Objects > Case Drug History > Layouts.
2. Select Case Drug History Detail Page Layout.
3. Insert a Detail Form section with the following settings:
   • Section Label: Name Parts
   • Section Name: name_parts__c
4. Select Done.
5. Add the following fields to the Name Parts section:
   • Container Name Part
   • Device Name Part
   • Form Name Part
   • Invented Name Part
   • Scientific Name Part
   • Strength Name Part
   • Trademark Name Part
   • Intended Use Name
6. Select Save.

Insert a Related Object Section to Case Drug History

1. On the Case Drug History Detail Page Layout, insert a Related Object section with the following settings:
   • Related Object: Case Drug History Substance
   • Section Label: Case Drug History Substance
   • Section Name: case_drug_history_substance__c
2. Select Done.
3. Using Edit Default Columns, we recommend adding the following columns for this section:
   • Case
   • Case Drug History
   • Strength (Number)
   • Strength (Unit)
   • Substance Name
   • TermID
   • TermID Version
4. Select Save.

Update the Case Drug History Substance Lifecycle

Add Roles to Case Drug History Substance Lifecycle

1. Go to Configuration > Object Lifecycle > Case Drug History Substance Lifecycle.
2. In the Roles section, select .
3. Select to add the following roles:
   • Data Entry
   • Distribution Manager
   • Head of Safety
   • Intake
   • Medical Coder
   • Medical Reviewer
   • Quality Controller (QC)
   • Safety Operations
   • Safety Writer
   • Translator
4. Select OK.

Permission Sets

Configure role permissions on the Case Drug History Substance Lifecycle by selecting Edit in the Roles section.

1. Select the Read permission checkbox for all roles in all Case Drug History Substance lifecycle states.
2. Select the Edit and Delete permission checkboxes for the Active state for the following roles:
   • Data Entry
   • Editor
   • Head of Safety
   • Medical Coder
   • Medical Reviewer
   • Owner
   • Quality Controller (QC)
3. Select the Edit and Delete permission checkboxes for the Inactive state for the following roles:
   • Editor
   • Owner
4. Select Save.

Update the Case Drug History Substance Object

Enable Secure Relationship Option for Case Drug History Substance Fields

1. In the Fields tab on the Case Drug History Substance object, select Case Drug History.
2. Select the Secure relationship checkbox and Save.
   
3. Go to the Fields tab, select Case, and repeat step 2.

Add Sharing Rules to Case Drug History Substance

1. Go to the Details tab and select Edit.
2. Select the Enable Matching Sharing Rules checkbox.
   
3. In the Sharing Rules tab, select Create.
4. Complete the following fields using the image below for all the sharing rules displayed:
   • Label: Enter the sharing rule label.
   • Name: This field should populate automatically.
   • Role: Select a role from the picklist.
   • Under Rule Criteria, select the checkbox beside Organization (organization__v).

Update Entry Actions for Case Lifecycle States

Add the Change State to Locked Entry Action on Approved State

1. Go to Configuration > Object Lifecycles > Case Lifecycle.
2. Select the Approved state to open it.
3. Select Edit from the Entry Actions section, then select Add Action.
4. Complete the following fields:
   • Select Change related object lifecycle state from the drop-down menu.
   • Related Object: Case Drug History Substance
   • Role: Select a role from the picklist.
   • Change State To: Locked
     
5. Select Save.

Add the Change State to Closed Entry Action on Closed State

1. Select the Closed state on the Case Lifecycle.
2. Select Edit from the Entry Actions section, then select Add Action.
3. Complete the following fields:
   • Select Change related object lifecycle state from the drop-down menu.
   • Related Object: Case Drug History Substance
   • Change State To: Closed
4. Select Save.

Add the Change State to Active Entry Action on Revision State

1. Select the Revision state on the Case Lifecycle.
2. Select Edit from the Entry Actions section, then select Create Entry Action at the bottom of the page.
3. Select Perform with Conditions.
   • Beside If, select Version Control in the first drop-down menu.
   • Select Include in the second drop-down menu.
   • Select Major (Approved) and Minor in the third drop-down menu.
4. Under perform actions, complete the fields:
   • Select Change related object lifecycle state from the drop-down menu.
   • Related Object: Case Drug History Substance
   • Change State To: Active
5. Select Save.

Update Permission Sets for Case Drug History Substance Object

We recommend updating certain permission sets with the configurations below for this feature.

In the Admin area, go to Users & Groups > Permission Sets. Use the following table to update the permission sets for the Case Drug History Substance object.

Permission Set	Object Permission	Object Field Permission
Case Distribution Manager	Read	Read
Case Entry Actions	Read, Create, Edit, Delete	Read Edit (on all standard fields excluding Case)
Case Intake Actions	Read	Read
Case Review Actions	Read	Read
Case Translation Actions	Read	Read
Safety Operations Actions	Read	Read
Safety Writer	Read	Read
Submission Actions	Read	Read

When necessary, update any applicable permission sets with Read, Create, Edit, and Delete permissions for the Case Drug History Substance object.