# 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
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
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 the add (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-blue-square-add-button.png" alt="add-icon" style="" />) icon.
3. Select the add (<img class="inline" src="https://platform.veevavault.help/assets/images/saf-add-button.png" alt="add-button" style="" />) icon 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.

<table>
    <thead>
      <tr>
         <th>Permission Set</th>
         <th>Object Permission</th>
         <th>Object Field Permission</th>
      </tr>
   </thead>
   <tbody>
      <tr>
         <td>Case Distribution Manager</td>
         <td>Read</td>
         <td>Read</td>
      </tr>
      <tr>
         <td>Case Entry Actions</td>
         <td>Read, Create, Edit, Delete</td>
         <td>Read<br>Edit (on all standard fields excluding Case)</td>
      </tr>
      <tr>
         <td>Case Intake Actions</td>
         <td>Read</td>
         <td>Read</td>
      </tr>
      <tr>
         <td>Case Review Actions</td>
         <td>Read</td>
         <td>Read</td>
      </tr>
      <tr>
         <td>Case Translation Actions</td>
         <td>Read</td>
         <td>Read</td>
      </tr>
      <tr>
         <td>Safety Operations Actions</td>
         <td>Read</td>
         <td>Read</td>
      </tr>
      <tr>
         <td>Safety Writer</td>
         <td>Read</td>
         <td>Read</td>
      </tr>
      <tr>
         <td>Submission Actions</td>
         <td>Read</td>
         <td>Read</td>
      </tr>
   </tbody>
</table>

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