Approve CAPA

When a CAPA record enters the approval workflow, the designated authorities are responsible for advancing the record through each stage until it reaches the final stage. At the final stage, a user (typically an Approver) reviews and approves the record, thereby resolving it.

To approve and resolve a record, follow the steps below.

  1. Login as a user who is assigned as an authority in the first stage of the workflow and click on the Open CAPA button from the email notification.

  2. Additionally, users can access the CAPA record assigned to them by setting the My Assignments view from the dropdown at the top.
  3. On the CAPA records screen, click on the Claim button.

    Note:

    • The ‘Claim’ button appears when there are multiple authority types in the workflow stage, and any one of the authorities should manually claim the record.
    • If there is only one user in a stage, the record is auto-claimed.
  4. Once the assigned authority clicks the ‘Claim’ button, the record is claimed by that authority and the action buttons appear as configured in the workflow.

  5. Click on the Complete button, fill in the necessary details in the Complete Implementation form, and click on the Complete button.

    Note: The display of forms and other sections, upon clicking an action button, depends on the Triggers configured within the workflow.

  6. Once the record is completed, it is transitioned into the next stage, i.e., Implementation Approval, and the record displays the statuses as configured in the workflow.

    Note: Follow the steps from STEP 1 to STEP 6 to complete the record transition to the last stage.

  7. As the assigned authority in the last stage, access the CAPA record through the email notification or the My Assignments view.

  8. Click on the Approve button above the Quick View panel.

  9. Enter the required details in the Approval Execution Form and click on the Approve button.

  10. Once the CAPA is successfully resolved, all the authorities for whom the notifications are enabled, receive an email stating the CAPA is resolved.

  11. On the CAPA records page, click on the Close CAPA button above the Quick View panel.

  12. On the Close CAPA popup, mandatorily add a comment and click on the Close CAPA button.