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, Case and Submission Validation 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. Set the Action Label to: “Evaluate Regulatory Conformance.”
  5. Select Save.

Evaluate Regulatory Conformance User Action

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.

Evaluate Regulatory Conformance Entry Action

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

The following image shows these Entry Criteria:

Approved Case Lifecycle Entry Criteria

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:

Permission Set Object Object Type Permission Field Permission Action Permission
Administration Actions Validation Criteria - Read All Fields Read - -
Administration Actions Validation Result - Read All Fields Read - -
Case Distribution Actions Validation Criteria - Read All Fields Read - -
Case Distribution Actions Validation Result - Read All Fields Read - -
Case Entry Actions Validation Criteria - Read All Fields Read - -
Case Entry Actions Validation Result - Read All Fields Read - -
Case Intake Actions Validation Criteria - Read All Fields Read - -
Case Intake Actions Validation Result - Read All Fields Read - -
Case Review Actions Validation Criteria - Read All Fields Read - -
Case Review Actions Validation Result - Read All Fields Read - -
Safety Operations Actions Validation Criteria - Read All Fields Read - -
Safety Operations Actions Validation Result - Read All Fields Read - -
Safety Writer Validation Criteria - Read All Fields Read - -
Safety Writer Validation Result - Read All Fields Read - -
Submission Actions Validation Criteria - Read All Fields Read - -
Submission Actions Validation Result - Read All Fields Read - -
Case Translation Actions Case - - - - Evaluate Regulatory Conformance No Access
Lock Manager Actions Case - - - - Evaluate Regulatory Conformance No Access
Safety Writer - - - - - Evaluate Regulatory Conformance No Access