Create a Standalone CAPA

The first step in the CAPA planning process is to create a Standalone CAPA. A Standalone CAPA record serves as the primary record for your change/improvement, to which you can add other records for documenting and tracking information during CAPA planning and implementation.

To create a Standalone CAPA:

1. In Quality Events > Standalone CAPAs, click Create.
2. Enter a Title.
3. Enter a detailed Description for the change, including the current state and intended final state.
4. Enter a Justification for why the change is needed.
5. Select the Source.
6. Select the Owning Facility that is responsible for managing the CAPA.
7. Select the Owning Department that is responsible for managing the CAPA.
8. Select the Current Due Date, which is the date the CAPA implementation and approval must be completed by. You can edit this date until the initial plan is approved, after which you must create an Extension Request.
9. Click Save. Vault assigns the Standalone CAPA a Record Number, creates the Standalone CAPA record with a status of Define Team, and opens the Standalone CAPA page.
10. Expand the Team section and click Manage Team.
11. Search for and select the Owner responsible for creating the CAPA plan and actions and one or more QA Approvers responsible for approving the CAPA plan. A QA Approver cannot be the same user as an Owner.
12. Click Save to save the selected team members. Vault updates the Standalone CAPA status to CAPA Planning, and assigns a Complete CAPA Plan task to the selected Owner.