Assess a Major or Critical Internal Deviation

Who can complete this task? Veeva Quality Basics: Deviation Owner

When a Deviation is first created, Vault assigns a Complete Assessment task to the Deviation Owner.

For Major or Critical internal Deviations, the Deviation record is managed in four (4) main stages: assessment, approval, investigation, and final approval & closure.

Screenshot major or critical deviation process

To assess a Major or Critical Internal Deviation:

  1. Access the Deviation from the assigned task.

    Screenshot step 1

  2. Click Edit, then review and update any deviation info as needed.

    Screenshot step 2

  3. Select Major or Critical for the rating based on your assessment.

    Screenshot step 3

  4. Click Save.

    Screenshot step 4

  5. Click Complete in the Complete Assessment task banner to open the Complete Assessment dialog and select the appropriate verdict.

    Screenshot step 5

  6. To send the Deviation for approval, select the Complete verdict and click Complete. Vault updates the Deviation status to In Approval and assigns a Quality Approval task to the Deviation QA Approver.

    Screenshot step 6

  7. To request cancellation of the Deviation, select the Request Cancellation verdict, enter the Cancellation Reason, and click Complete. Vault changes the Deviation status to Pending Cancellation and assigns an Approve Deviation Cancellation task to the QA Approver.

    Screenshot step 7