Validation Management has introduced template capabilities for Test Protocols and Test Scripts that, when enabled, allow users to create Test Protocols and Test Scripts from a Template Test Protocol or Template Test Script record, including test steps and additional prompts. This helps organizations develop and manage a standardized, approved repository of templates for creating Test Protocols and Test Scripts.
Validation Management also has enhanced Template Requirements for improved consistency and usability by utilizing the existing Validation Requirement object and aligning with the paradigm for Template Test Protocols and Test Scripts. By leveraging the Validation Requirement object, Template Requirements can now support versioning and Validation Teams. This change also introduces two new Admin settings that must be enabled to use this enhanced functionality and to migrate existing Template Requirements: the Refactor Template Requirement setting and the Migration Template Requirement setting.
Note: In 25R3, the enhanced Template Requirements functionality will become mandatory. Review your current Template Requirement-related configurations and plan for migration and enablement before 25R3.
Creating Template Requirements
Maintaining a set of Template Requirements helps your organization establish an approved repository of Template Requirements available for use in different types of entities. If configured by an Admin, you can import sets of Template Requirements to a Validation Entity.
See Managing Requirements for steps to import Template Requirement Sets and create Template Requirements when the Refactor Template Requirement setting is not enabled.
Creating Template Requirement Sets
To create a Template Requirement Set:
- Navigate to Business Admin or a custom Template Requirement Set object tab.
- Click Create.
- Enter the required details.
- Click Save.
- In the Template Requirement section, add or create Template Requirements.
Creating Template Requirements
To create a Template Requirement when the Refactor Template Requirement setting is enabled:
- Navigate to the Template Entity that you want to add Template Requirements to.
- Navigate to the latest Validation Entity Version for the Template Entity.
- In your custom Requirement Entity Version section, click Create. The default object type is associated with the Create button.
- Optional: Use the drop-down on the Create button to select a different record option based on your active object types.
- Enter needed details such as the Description, Requirement Category, Requirement Source, Requirement Source Details, and Requirement Suffix.
- Click Save.
To create a Template Requirement when the Refactor Template Requirement setting is disabled:
- Navigate to Business Admin or a custom Template Requirement object tab.
- Click Create.
- Enter the required details.
- Click Save.
Creating Template Entities
Validation Template Managers can manage a library of templates for Test Protocols and Test Scripts that Test Authors in turn can use to create new Test Protocols and Test Scripts. Before creating the Template-related records such as Template Requirements, Template Test Protocols, and Template Test Scripts, Template Managers must create Template Entities to contain them.
Creating a Template Entity
To create a Template Entity:
- Navigate to the Template Entities tab.
- Create a Template Entity.
- Set the Is Template? field to Yes, and complete the necessary fields for the Template Entity.
- Click Save.
Creating Test Protocols and Test Scripts
Validation Template Managers can add Validation Team Members to the team for a Template Entity and then create a new Test Script or Test Protocol as a template for the Template Entity. Test Authors then can select the Template Test Script or Test Protocol, perform the action to deep copy it, and select a target deliverable or create a new deliverable. Vault copies the selected Test Script to the deliverable or Test Protocol through a job and sends a notification when the process is complete.
Creating Template Test Protocols
To create a Template Test Protocol:
- Navigate to the Template Entity that contains the Template Test Protocols.
- Select the Entity Version that the Template Test Protocol belongs to.
- Create a Template Test Protocol in the Template Test Protocol section.
- Complete the necessary fields for the Template Test Protocol.
- Click Save.
Creating Template Test Scripts
To create a Template Test Script that is not part of a Template Test Protocol:
- Navigate to the Template Entity that contains the Template Test Protocols.
- Select the Entity Version that the Template Test Script belongs to.
- Create a Template Test Script in the Template Test Script section.
- Complete the necessary fields for the Template Test Script.
- Click Save.
To create a Template Test Script that is part of a Template Test Protocol:
- Navigate to the Template Test Protocol that contains the Template Test Scripts.
- Create a Template Test Script from the Test Script section.
- Complete the necessary fields for the Template Test Script.
- Click Save.
Configuring Template Requirements
Before enhanced Template Requirements can be used, Admins must enable the Refactor Template Requirement setting from the Admin > Settings > Application Settings section under Validation.
Admins can configure the enhanced Template Requirements capabilities by completing the following steps:
- Configure the Validation Req - Template Req Set object.
- Enable the Is Template? and Template Requirement fields for all of the object types in the Validation Requirement object.
- Configure the Available for Use lifecycle state with the appropriate entry criteria, entry actions, and user actions based on your business needs.
- Add the Import Template Requirement Set user action to the Validation Entity Version object lifecycle for importing Template Requirement Sets.
Migrating Existing Template Requirements
For organizations that use the legacy Template Requirement functionality, existing Template Requirement records can be migrated to the Validation Requirement object by enabling the Migrate Template Requirement setting from the Admin > Settings > Application Settings section under Validation. If any missing records need to be migrated, this setting can be retoggled to migrate additional records.
Before migration begins, ensure that all Template Requirement records are in the proper state. Vault can only migrate existing Template Requirement records that are in states mapped to the Initial state type and the Available for Use state type. These records will be migrated to the matching states in the Validation Requirement object lifecycle. Also ensure that the existing Template Requirement field does not have Criteria VQL configured to filter the state. As Vault migrates records in the Initial state, the Criteria VQL causes a failure.
Migration Steps
Complete the following steps to migrate existing Template Requirement records to the Validation Requirement object:
- Ensure that the Migrate Template Requirement setting is enabled.
- Once the migration job runs, ensure that you receive a notification that the migration is complete.
- Confirm that Vault has created a Validation Entity record called Template Requirement Entity (Migrated) and that its type is CSV.
- Ensure that all existing Template Requirements in the Initial state type and the Available for Use state type have been migrated to this Validation Entity. This Entity does not have an Entity Version. If you want to use new Template Requirements in different Template Entities, update the Validation Entity value to move and link to Entity Versions.
- Confirm that the new Template Requirements have the existing Template Requirement value so that users can still see eSignatures.
Configuring Template Test Protocols and Test Scripts
Admins can configure Template Test Protocols and Test Scripts by completing the following steps:
- Enable the Is Template? field for all of the object types for Validation Entity and Validation Entity Version objects.
- Configure the Template Viewer role. Add the role to the Validation Test Protocol and Validation Test Script object lifecycles.
- Update the page layouts for the Validation Entity, Validation Entity Version, Test Protocol, and Test Script.