Managing Requirements (Validation Management)

In Vault Validation Management, Business Process Owner or System Owner users can create user requirements, functional requirements, and design specifications individually or import via a templated set of requirements. This can allow your organizations to harmonize practices across departments and global sites and establish a library of commonly used requirements and specifications as new systems, equipment, processes, and other GxP systems and processes are introduced in production.

Creating Requirements

Depending on your configuration, only certain members of a Validation Entity’s Validation Team can create requirements for it. To create Validation Requirements:

  1. Navigate to Business Admin or a custom Validation Requirement object tab.
  2. Click Create.
  3. Select a Validation Requirement Type.
  4. Click Continue.
  5. Enter the required details.
  6. Optional: Select a Template Requirement. If selected, the template will populate the following fields on the requirement: Description, Requirement Category, Requirement Source, and Requirement Source Details.
  7. Click Save. If configured by an Admin, Vault automatically populates the Name field with the appropriate naming scheme.

The Validation Entity Version field on the Validation Requirement object indicates which entity version first used the requirement. Users do not need to manually enter the value for the field. Once a user associates a requirement with an entity version, Vault automatically updates the Validation Entity Version field.

Creating Requirements from Templates

Maintaining a set of template requirements helps your organization establish an approved repository of template requirements available for use in different types of entities regardless of validation discipline. If configured by an Admin, you can import sets of requirements to a Validation Entity.

To add requirements from a template:

  1. Navigate to a Validation Entity record, via Business Admin or a custom Validation Entity Version object tab.
  2. Perform the Import Template Requirement Sets action.
  3. In the dialog, select one or more Template Requirement Sets.
  4. Click Save.

Creating Template Requirements

To create template requirements:

  1. Navigate to Business Admin or a custom Template Requirement object tab.
  2. Click Create.
  3. Enter the required details.
  4. Click Save.

Creating Template Requirement Sets

In order to add multiple requirements to a Validation Entity at once, you must have sets of template requirements to draw from. To create a Template Requirement Set:

  1. Navigate to Business Admin or a custom Template Requirement Set object tab.
  2. Click Create.
  3. Enter the required details.
  4. Click Save.
  5. In the Template Requirement section, add or create Template Requirements.

Linking Requirements to Entity Families

If configured by an Admin, you can perform the Sync Entity Family Requirement action to link your requirements to an Entity Family. This can help you manage the qualification and validation of either identical or equivalent entities by grouping these assets under a single Entity Family record.

To manage requirements, a user requires a security profile or role which grants the following permissions:

  • Read, Create, Edit, and Delete on the Validation Requirement, Template Requirement, and Template Requirement Set objects