Enable Generate Assessments Record Action

Veeva Safety gives Case Processors the ability to generate Case Assessments, Case Assessment Results, and Case Assessment Expectedness records for all serious and non-serious Adverse Events on a Case. Completed in a single action, this feature improves case processing efficiency by removing the need to generate each required record manually.

With the Generate Assessments Record Action feature enabled, when users run the Generate Assessments action, Vault generates assessments for all serious and non-serious Adverse Events paired with all Case Products that have an eligible Drug Role, if they do not already exist.

After you have configured this feature, see Generate Assessments and Case Data Entry Overview for more information.

Updates

We have added the following updates to this feature:

  • Product Quality Complaint Assessments: With the 26R1 release, Veeva Safety supports assessment generation for Product Quality Complaints (PQCs). For Case Adverse Events with Product Quality Complaint as the Type, Vault generates a single assessment for the Case Adverse Event and PQC Product pair. Unlike for non-PQC Case Adverse Events, Vault does not pair that event with all eligible Case Products to generate additional assessments. This feature reduces the overgeneration of assessments for PQCs, resulting in more efficient and accurate case processing. Although this feature is Auto-on, some components require additional configuration.
  • Exclude External Products During Assessment Generation: With the 25R2 release, you can configure your Vault to exclude External Products during assessment generation. This reduces assessment overgeneration and the manual work for Case Processors to delete unnecessary assessments. To configure this feature in your Vault, see (25R2) Enable Exclude External Products During Assessment Generation.
  • Auto-Generate Serious and Non-Serious Assessments and Generate Assessments Record Action Enablement Change: With the 23R2 release, Veeva Safety has enhanced this feature with the automatic generation of Case Assessments, Case Assessment Results, and Case Assessment Expectedness records for all serious and non-serious adverse events on a Case. Auto-generation is available on Case promotion and when adding or editing Case Products or Case Adverse Events. In addition, the Generate Assessments Record Action feature no longer requires Support enablement. See the following sections to configure your Vault with these features:

(23R1) Configure Generate Assessments Record Action

To configure your Vault for the Generate Assessments user action, you must update the Case object and object lifecycle.

Add the Generate Assessments Action to the Case Object

To add the Generate Assessments action to the Case object:

  1. Navigate to Admin > Configuration > Objects > Case > Actions.
  2. Select Create.
  3. In the Create Action window, select Generate Assessments from the picklist and then select Continue.
  4. (Optional) On the Create Action page, in the Description field, enter “Generate Assessments, Assessment Results, and Expectedness for all Case Adverse Events.”
  5. Select Save.

Add the Generate Assessments Action to the Case Object Lifecycle

To add the Generate Assessments action to the Case object lifecycle:

  1. Navigate to Admin > Configuration > Object Lifecycles > Case Lifecycle > States.
  2. Select a state. We recommend adding the action to the Triage and Data Entry states.
  3. In the User Action section, select Edit.
  4. Add an action with the following setup:
    • Always
    • Generate Assessments
    • Action Label: Generate Assessments
  5. Select Save.

(23R2) Configure Auto-Generate Serious and Non-Serious Assessments

To configure your Vault to auto-generate Assessments, you must turn on the feature in Safety General Settings and then update the Case layout.

Turn On Auto-Generate Serious and Non-Serious Assessments

To turn on auto-generating Assessments in your Vault:

  1. Navigate to Admin > Settings > Safety General Settings.
  2. Select Edit.
  3. In the Auto-generate Assessments section, select the Generate Assessments for both Serious and Non-Serious Adverse Events checkbox.
  4. Select Save.

Update the Case Layout

To update the Case layout to support auto-generating Assessments:

  1. Navigate to Admin > Configuration > Objects > Case > Layouts > Case Page Layout.
  2. Delete the following standard sections, as applicable to your organization’s processes:
    • Assessments
    • Assessment Results
    • Expectedness
  3. Replace each of the standard sections you deleted with its corresponding control section:
    • Slider Case Assessment
    • Slider Case Assessment Results
    • Slider Case Assessment Expectedness
  4. Select Save.

(25R2) Enable Exclude External Products During Assessment Generation

To configure your Vault to exclude External Products when generating assessments:

  1. Navigate to Admin > Settings > Safety General Settings.
  2. Select Edit.
  3. In the Auto-generate Assessments section, select the Exclude External Products when Generating Assessments checkbox.
  4. Select Save.

(26R1) Configure Product Quality Complaint Assessments

To configure your Vault for the Product Quality Complaint Assessments feature, complete the applicable procedure.

Update the Case Adverse Event Layout

Add the PQC Product field to the Details section of the Case Adverse Event object layout.