This article provides best practice information for configuration of essential pieces of Validation Management, including automation, general data record setup, and team assignments. If you run into problems configuring components or setting up data for Validation Management, contact Vault Support.
Follow these steps to get started in Validation Management. First, ensure that configuration best practices are followed in your Vault. Validation Management automation and user actions are configured on appropriate object lifecycle states and workflows:
- Create Initial Validation Entity
- Create Validation Entity Version
- Create Validation Requirement Version
- Complete Associated Deliverable Record
- Define Executors
- Verify Test Step Completion
- Calculate Step Numbers
- Author Test
- Review Authored Test
- Execute Test
- Pause, Terminate, or Resume Test
- Review Test Script
- Review Executed Protocol
Configure Validation Management user actions, such as Author Test, Review Test Script, and Review Executed Protocol.
Then, create object data to support validation activities: Validation Inventory Items, Validation Entities, Validation Requirements, Validation Activities, and Validation Deliverables. When creating Validation Inventory Items, you may also define Validation Team Assignments.
Finally, create Test Scripts and Test Protocols to fulfill Testing Deliverables. Some organizations may prefer to just use stand alone test scripts and others may prefer to have Test Protocols that are made up of narrative content as well as one or several test scripts.
Validation Management Automation Actions
Validation Management relies on several actions to facilitate the smooth operation of data management and test execution.
Ensure that Create Initial Validation Entity event action is configured to trigger upon record creation in the Validation Inventory Item Lifecycle. This creates a Validation Entity record of a Validation Inventory Item upon creation, and ensures that we always have a first instance of an inventory item in the system. Even if the inventory item is an asset which does not have versions, Validation Management relies on having at least one Validation Entity record.
Ensure that the Create Validation Entity Version action is configured as an entry Action and user action on the Validation Entity Lifecycle. This action should be configured with the condition: If Versionable? > equals > Yes. This action creates a copy of the previous Entity along with all requirements associated with the previous entity.
Ensure that the Create Validation Requirement Version user action is configured on the Validation Requirement Lifecycle in the approved lifecycle state. This action creates a new version of a requirement when an existing requirement needs to be modified.
Admins can configure documents to automatically complete associated validation deliverables upon the document reaching a steady state. Only Validation Deliverable records that are not in the Completed or Cancelled states are automatically completed. This entry action also updates the Vault Document field on the Validation Deliverable record while maintaining the latest version in the Vault Document (Latest) field.
To configure this feature:
- Add the Validation Deliverable Closure Check shared field to the Validation document type.
- Add the Complete Associated Deliverable Records entry action to the steady state of the document lifecycle associated with your Vault’s Validation document type. For example, if validation documents are associated with the Draft to Approved Lifecycle, add the action to the Approved state.
- Within the Validation Deliverable Lifecycle, associate the Completed state with the Complete State state type. Associate the Cancelled state with the Cancelled state type.
- Add the Vault Document (Latest) field to the page layout of the desired Validation Deliverable object types.
- Recommended: Add entry criteria to the Completed state to check whether at least one document is associated with the Vault Document (Latest) field.
Ensure that a Participants Control on the VAL: Test Script Execution Workflow is configured with the custom action: Define Executors. This action ensures that Executors assigned to perform one or more test steps in a test script only receive one workflow task.
Ensure that a workflow task on the VAL: Test Script Execution Workflow is configured with the custom action: Verify Test Step Completion. This action ensures that all steps assigned to an Executor are in the Completed lifecycle state before the Executor’s workflow task can be completed.
When authoring a test, rearranging steps can result in Step Number field values with long decimal values, which could be confusing to Executors and unwanted in formatted outputs. The Calculate Step Numbers action simplifies the Step Number field values to the appropriate integers. You can configure this action as a user action or as an entry action or both. This action should be configured both on a state prior to, as well as in, the pre-approved lifecycle state.
Validation Management User Actions
Validation Management user actions facilitate easy test authoring, test authoring review, test execution, test execution review, and executed protocol review. Ensure that users expected to perform these actions have the appropriate View and Execute permissions in Admin > Users & Groups > Permission Sets > Object > [object] > Object Action Permissions.
Make the following user actions available in the Test Script object lifecycle at the appropriate states:
- Author Test in the In Authoring (
in_authoring_state__v) lifecycle state
- Review Authored Test in the In Pre-Approval (
in_pre_approval_state__v) lifecycle state
- Execute Test in the In Execution (
in_execution_state__v) lifecycle state
- Pause Test in the lifecycle state associated with the In Execution (
val_in_execution__v) state type
- Terminate Test in the lifecycle state associated with the In Execution (
val_in_execution__v) state type
- Resume Test in the lifecycle state associated with the Execution Paused (
val_execution_paused__v) state type
- Review Test Script in the In Independent Review (
in_independent_review_state__v) or the In Approval (
in_approval_state__v) lifecycle state
- Deep Copy Test Script in any lifecycle state. Indicate a Target Lifecycle State and name the label according to the target state. For example, a user action labeled Re-Run Test Script copies a test script and transitions it to the Pre-Approved (
pre_approved_state__v) lifecycle state.
Make the Review Executed Protocol action available to users in Test Protocol Lifecycle states where approval is taking place, such as In QA Approval, In Independent Review, or In Approval. An entry criteria is required in these states to check all related test scripts to make sure that they are not in any of the authoring or execution related lifecycle states, for example, Draft, Pre-Approved, or In Execution.
Validation teams define how permissions apply across records in the Validation Management application. Users with Validation Team Assignment records associated with a Validation Inventory Item are granted record visibility access rights to all validation-related object records that share the same Validation Inventory Item.
Vault provides the following system-managed Validation Team Roles:
- Business Process Owner: The individual who owns and manages the business process for the Validation Inventory Item. This role gives Read, Create, Edit, and Delete permissions for the Validation Inventory Item and Validation Entities and the Read permission for all records associated with the Validation Inventory Item.
- Quality Assurance: The individual from the Quality Unit who provides necessary reviews and approvals related to the Validation Inventory Item. This role gives the Read permission for all records associated with the Validation Inventory Item.
- System Owner: The individual who owns and manages the Validation Inventory Item. This role gives Read, Create, Edit, and Delete permissions for the Validation Inventory Item and Validation Entities and the Read permission for all records associated with the Validation Inventory Item.
- Validation Contributor: The individual who participates in the validation project as a member for the Validation Inventory Item. This role gives Read permission for all records associated with the Validation Inventory Item.
- Validation Lead: The individual who leads the validation project for the Validation Inventory Item. This role gives the Edit permission for the Validation Inventory Item and Validation Entities.
Users who require view access to all validation records should be assigned as Validation Viewer through their user role.
Configuring Page Layouts
Before incorporating a validation team into your existing business process, configure the following object page layouts to accommodate this feature:
- Add the Validation Team Assignment object as a related object section on all Validation Inventory Item object type page layouts.
- Add a Validation Application User control for the owner fields on the page layouts of the following objects: Validation Requirement, Validation Activity, Validation Deliverable, Test Protocol, Test Script, Test Step, and Discrepancy. For example, the page layout for the Validation Requirement object should have a user control for the Requirement Owner field. Remove existing owner fields from the page layout to avoid confusion.
- Optional: Ensure the Validation Inventory Item field exists on the page layouts of the following objects: Validation Requirement, Validation Activity, Validation Deliverable, Test Protocol, Test Script, Test Step, Discrepancy, Test Script Execution Change, and Test Step Change.
- Optional: Add the Role Dependency and Validation Team Assignment objects as related object sections on the Validation Team Role page layout.
Before incorporating a validation team into your existing business process, configure the following object lifecycles to accommodate this feature:
- Add the Assign Record Creator to Validation Team Role action to the Create Record event on the Validation Inventory Lifecycle. Indicate a Validation Team Role that the record creator is assigned to.
- Add the system-managed application roles to the lifecycles of the following objects: Validation Inventory Item, Validation Entity, Validation Requirement, Validation Activity, Validation Deliverable, Test Protocol, Test Script, Test Script Execution Change, Test Step, Test Step Change, and Discrepancy.
Note: Remove the Assign Record Creator to Validation Team Role event action temporarily until migration activities are complete. Once you configure the event action, a record creator is automatically assigned to the Validation Inventory Item and a single user cannot have more than 500 Validation Inventory Item records.
You can configure your workflow start steps to use roles from Validation Teams as workflow participants. The workflow will get users from roles through Validation Team Assignment as well as standard user reference fields such as Requirement Owner, Activity Owner, Deliverable Owner, Author, Executor, and Discrepancy Owner.
To use roles from Validation Teams as workflow participants, configure the start step with either the Allow workflow initiator to select participants or Use roles as participants options.
Ensure that the desired users have the following object permissions added to their security profile:
- Validation Team Assignment: Read, Create, Edit, Delete
- Validation Team Role: Read
- Role Dependency: Read
Ensure that the desired users have the following object control permissions for the Validation Application User control added to their security profile:
- Validation Requirement: Read
- Validation Activity: Read
- Validation Deliverable: Read
- Test Protocol: Read
- Test Script: Read
- Test Step: Read
- Discrepancy: Read
Enabling Validation Teams
After configuration is complete, contact Veeva Support to enable this feature. Vault does not apply security to migrated Validation Team Assignment records unless validation teams are enabled prior to migration.
To assign users to a team role:
- Navigate to a custom object tab for Validation Inventory Items or Business Admin > Objects > Validation Inventory Items and select a record.
- In the Validation Team Assignments section, click Create.
- Select a User and assign them a Validation Team Role.
- Click Save.
Keep the following limitations in mind when working with Validation Team Assignments:
- A user can be assigned to a Validation Team Role on a maximum of 500 Validation Inventory Item records.