# Enable E2B Case and Submission Validation

Learn how to update your Vault's configuration to enable E2B Case Validation and Submission.

## About the Feature

Support for E2B Case Validation and Submission was added in 20R3. Vaults created in 20R3 or later include this functionality by default, while Vaults created in 20R2 or earlier must have the configuration upgrades described on this page to enable this feature.

Additional support for VAERS data validation and EMA E2B(R3) submission validation was added in 21R1. Vaults created in 21R1 or later include this functionality by default, while Vaults created in 20R3 or earlier must have the configuration upgrades described on this page to enable this feature. Feature enablement specific to 21R1 will be denoted in the instruction header as (21R1).

Once configured, <a href="/en/gr/01226/">Case and Submission Validation</a> provides more information on using this feature.

### Case Object

Make the following changes to the **Case** object:

1. Create an _Evaluate Regulatory Conformance_ action. Leave the default settings.
2. Add the _Evaluate Regulatory Conformance_ action to the Case object type.

## Update Object Lifecycles

Manage object lifecycles from **Configuration > Object Lifecycles**.

## Lifecycles and Workflows

Complete the procedures in this section to update lifecycles and workflows related to this feature.

### Add the Evaluate Regulatory Conformance Action on the Case object

1. In Admin, go to **Configuration > Objects > Case > Actions.**
2. Select **Create.**
3. Select **Evaluate Regulatory Conformance.** Ensure **Available in All Lifecycle States** is unselected.
4. Select **Continue.**
5. Select **Save.**

### Add the Evaluate Regulatory Conformance to the Case Object Type

1. In Admin, go to **Configuration > Objects > Case > Object Types > Actions.**
2. Add the **Evaluate Regulatory Conformance** action to the **Case** object type. Ensure the Evaluate Regulatory Conformance Action is only added to the **Case** object type.
3. Select **Save.**

### Add the Evaluate Regulatory Conformance User Action to the QC Lifecycle State

1. In Admin, go to **Configuration > Object Lifecycles > Case Lifecycle > QC Lifecycle State.**
2. Under **User Actions**, add a new action.
3. Select **Allow** for the **Evaluate Regulatory Conformance** action.
4. For **Action Label**, enter `Evaluate Regulatory Conformance`.
5. Select **Save.**

### Add the Evaluate Regulatory Conformance Entry Action to the QC Lifecycle State

1. In Admin, go to **Configuration > Object Lifecycles > Case Lifecycle > QC Lifecycle.**
2. Under **Entry Actions**, add a new action.
3. Select **Evaluate Regulatory Conformance** from the drop-down menu.
4. Select **Save.**

### Remove the Generate Transmission Document(s) entry action from the Pending state of the Transmission lifecycle

1. In Admin, go to **Configuration > Object Lifecycles > Transmission Lifecycle**.
2. Open the **Pending** lifecycle state.
3. Select **Edit** from the **Entry Actions** section.
4. Select the **X** icon  next to the **Generate Transmission Document(s)** action.
5. Select **Save**.

### (Optional) Add Entry Criteria on Case Approved Lifecycle State for Transmission Error

This optional configuration is not included in the default template but prevents Cases containing Transmissions with Validation Errors or other Errors from moved to the Approved state. We recommend that Administrators add the Entry Criteria described in the following steps.

1. Go to **Configuration > Object Lifecycles > Case Lifecycle**.
2. Open the **Approved** state.
3. Add the following Entry Criteria:
    * Validate that there are no Transmissions in the Validation Error state
    * Validate that there are no Transmissions in the Error state

### Add Roles to Validation Result Lifecycle

In the **Validation Result Lifecycle**, add all Safety Application Roles.

## Update Objects

Manage Vault objects from **Configuration > Objects**.

### Validation Result Object

Make the following changes to the **Validation Result** object:

1. Under **Options**, enable the **Enable Matching Sharing Rules** option.
2. Add sharing rules for the following Application Roles:
    * Data Entry
    * Distribution Manager
    * Head of Safety
    * Intake
    * QC
    * Safety Operations

## Object Layouts

Complete the procedures in this section to update the object layouts related to this feature.

### Insert the Validation Result Layout

1. In **Admin**, go to **Configuration > Objects > Validation Result.**
2. On the **Layouts** tab, open the **Validation Result Detail Page Layout**. If this layout does not exist, create a new layout with this name for the Transmission Profile object type.
3. Update the Details section to match the following fields:
    * Validation Criteria
    * Conformance
    * Data Element
    * Data Element Name
    * Vault Object
    * Vault Field
    * Validation Status
    * Agency
    * File Format
    * Case
    * Transmission
4. Update the System Information section to match the following fields:
    * Created By
    * Created Date
    * Last Modified By
    * Last Modified Date
    * Lifecycle State
    * Organization
    * Name
    * Validation Criteria Version
5. Insert the **Workflow Timeline** section on the page.
6. Select **Save.**

#### (21R1) Add the Agency Field to the Validation Result Layout

1. In **Admin**, go to **Configuration > Objects > Validation Result**.
2. On the **Layouts** tab, open the **Validation Result Detail Page Layout**.
3. Select **Add** under the Details section.
4. Add the **Agency** field.
5. Select **Save**.

### Update the Validation Criteria Layout

1. In **Admin**, go to **Configuration > Objects > Validation Criteria.**
2. On the **Layouts** tab, open the **Validation Criteria Detail Page Layout.**
3. Update the **Details** section to match the following fields:
    * Name
    * Source
    * Conformance
    * Data Element
    * Data Element Name
    * Vault Object
    * Vault Field
    * Validation Status
    * Agency
    * File Format
    * Evaluation Level
    * Result Status Type
    * Rule Version
    * Rule Formula
4. Update the **System Information** section to match the following fields:
    * Created By
    * Created Date
    * Last Modified By
    * Last Modified Date
    * API Name
    * Lifecycle State
5. Insert a **Workflow Timeline** section on the page.
6. Select **Save.**

#### (21R1) Add the Superseded and Superseded Conformance Fields to the Validation Criteria Layout

1. In **Admin**, go to **Configuration > Objects > Validation Criteria**.
2. On the **Layouts** tab, open the **Validation Criteria Detail Page Layout**.
3. Select **Add** under the Details section.
4. Add the **Superseded** and **Superseded Conformance** fields.
5. Select **Save**.

### Modify the Case Layout on the Case Object

1. In **Admin**, go to **Configuration > Objects > Case.**
2. On the **Layouts** tab, open the **Case Page Layout.**
3. Insert a **Related Object** section with the following details:
    * **Related Object**: Validation Result
    * **Section Label**: Validation Results (Failures & Warnings)
    * **Creation Option**: Prevent record creation
    * **Filter Related List**: Transmission is Blank 
4. Select **Done.**

#### Update the Displayed Fields on the Validation Results 
1. Go to the **Validation Results Related Object** section.
2. Select **Edit Columns.**
3. Add the following columns to the **Selected Columns** section:
    * Validation Status
    * Conformance
    * Data Element
    * Data Element Name
    * Vault Field
    * Vault Object
    * File Format
    * Agency
    * Lifecycle State
4. Select **Done.**

### Modify the Submission Layout on the Transmission Object

1. In **Admin**, go to **Configuration > Objects > Transmission**
2. On the **Layouts** tab, open the **Submission Detail Page Layout.** If this layout does not exist, create a new layout with this name for the Transmission Profile object type.
3. Insert a **Related Object** section with the following details:
    * **Related Object**: Validation Result
    * **Section Label**: Validation Results (Failures & Warnings)
    * **Creation Option**: Prevent record creation
4. Select **Done.**

#### (21R1) Add the Agency Column to the Validation Results Section on the Submission Layout

1. In **Admin**, go to **Configuration > Objects > Transmission**.
2. On the **Layouts** tab, open the **Submission Detail Page Layout**.
3. Select **Edit** from the Validation Results section.
4. Add the Agency column from the Available Columns section by moving it into the Selected Columns section, using the arrow buttons.
5. Select **Done**.

### Modify the Distributions Layout on the Transmission Object

1. In **Admin**, go to **Configuration > Objects > Transmission**
2. On the **Layouts** tab, open the **Distribution Detail Page Layout.** If this layout does not exist, create a new layout with this name for the Transmission Profile object type.
3. Insert a **Related Object** section with the following details:
    * **Related Object**: Validation Result
    * **Section Label**: Validation Results (Failures & Warnings)
    * **Creation Option**: Prevent record creation
4. Select **Done.**

#### (21R1) Add the Agency Column to the Validation Results Section on the Distribution Layout

1. In **Admin**, go to **Configuration > Objects > Transmission**.
2. On the **Layouts** tab, open the **Distribution Detail Page Layout**.
3. Select **Edit** from the Validation Results section.
4. Add the Agency column from the Available Columns section by moving it into the Selected Columns section, using the arrow buttons.
5. Select **Done**.

#### Update the Displayed Fields on the Validation Results 

1. Go to the **Validation Results Related Object** section.
2. Select **Edit Columns.**
3. Add the following columns to the **Selected Columns** section:
    * Validation Status
    * Conformance
    * Data Element
    * Data Element Name
    * Vault Field
    * Vault Object
    * File Format
    * Agency
    * Lifecycle State
4. Select **Done.**

## Permission Sets 

Update permission sets according to the settings described in the following table:

<table>
    <thead>
      <tr>
         <th>Permission Set</th>
         <th>Object</th>
         <th>Object Type</th>
         <th>Permission</th>
         <th>Field</th>
         <th>Permission</th>
         <th>Action</th>
         <th>Permission</th>
      </tr>
   </thead>
   <tbody>
      <tr>
         <td>Administration Actions</td>
         <td>Validation Criteria</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Administration Actions</td>
         <td>Validation Result</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Case Distribution Actions</td>
         <td>Validation Criteria</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Case Distribution Actions</td>
         <td>Validation Result</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Case Entry Actions</td>
         <td>Validation Criteria</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Case Entry Actions</td>
         <td>Validation Result</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Case Intake Actions</td>
         <td>Validation Criteria</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Case Intake Actions</td>
         <td>Validation Result</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Case Review Actions</td>
         <td>Validation Criteria</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Case Review Actions</td>
         <td>Validation Result</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Safety Operations Actions</td>
         <td>Validation Criteria</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Safety Operations Actions</td>
         <td>Validation Result</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Safety Writer</td>
         <td>Validation Criteria</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Safety Writer</td>
         <td>Validation Result</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Submission Actions</td>
         <td>Validation Criteria</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Submission Actions</td>
         <td>Validation Result</td>
         <td>-</td>
         <td>Read</td>
         <td>All Fields</td>
         <td>Read</td>
         <td>-</td>
         <td>-</td>
      </tr>
      <tr>
         <td>Case Translation Actions</td>
         <td>Case</td>
         <td>-</td>
         <td>-</td>
         <td>-</td>
         <td>-</td>
         <td>Evaluate Regulatory Conformance</td>
         <td>No Access</td>
      </tr>
      <tr>
         <td>Lock Manager Actions</td>
         <td>Case</td>
         <td>-</td>
         <td>-</td>
         <td>-</td>
         <td>-</td>
         <td>Evaluate Regulatory Conformance</td>
         <td>No Access</td>
      </tr>
      <tr>
         <td>Safety Writer</td>
         <td>-</td>
         <td>-</td>
         <td>-</td>
         <td>-</td>
         <td>-</td>
         <td>Evaluate Regulatory Conformance</td>
         <td>No Access</td>
      </tr>
   </tbody>
</table>