Approve a Deviation Assessment

Who can complete this task? Veeva Quality Basics: QA Approver

After the Deviation Owner has completed the deviation assessment (and also the CAPA plan if the deviation was minor or external), the QA Approver will receive a Quality Approval task.

To approve a deviation assessment (and CAPA plan if applicable):

  1. Click the task link.

    Screenshot step 1

  2. Review the deviation and confirm the rating. If the deviation was minor or external (regardless of rating), also review the CAPA Plan.

  3. Click Complete to complete the task.

    Screenshot steps 2 and 3

  4. Provide your Verdict.

    • Approve - Select this verdict if the assessment (and CAPA plan if the deviation was minor or external) and provide your eSignature.

    • Reject - Select this verdict if further work is required and provide a reason.

  5. Click Complete.

    Screenshot steps 4 and 5

If the Deviation is minor or external, the deviation is closed and tasks are sent to the CAPA Action owners.

If the deviation is major or critical, the status changes to In Investigation and a task is sent to the Deviation Owner to complete the investigation and CAPA Plan.