Managing Regulatory Reference Requirements

Quality teams responsible for assessing the impacts of regulation changes to documents can manage these changes in Veeva QualityDocs. By mapping your regulatory requirement object to the document field used to associate regulatory requirements to documents in QualityDocs, your Quality teams save the time and effort it takes to manually map regulatory requirements from spreadsheets to Vault documents, and are provided flexibility in sourcing regulatory content. This feature supports functionality in future releases.

Configuring Regulatory Requirements

To configure regulatory requirements:

  1. Navigate to Admin > Configuration > Objects.
  2. Create a custom object. We recommend entering Regulatory Requirements as the Label.
  3. Navigate to Configuration > Document Fields.
  4. Create a custom document field.
  5. Return to Admin > Configuration and, under Quality Configurations, click Regulatory Reference Management Configurations.
  6. Click Create.
  7. Enter a Name.
  8. Select the custom object in the Regulatory Requirement Object drop-down.
  9. Select the custom document field in the Regulatory Requirement Doc Field drop-down.
  10. Click Save.

You can associate one or more regulatory requirement records to a document using the document field. Documents can reference more than one regulatory requirement.