Amending Closed Deviations

You can amend a Deviation after it is closed to add attachments or comments.

Requesting Deviation Amendment

Complete the following steps to request a Deviation amendment:

  1. Navigate to the closed Deviation you want to amend.
  2. From the Workflow Actions menu, select Request Amendment.
  3. In the Start dialog, select the QA Approver responsible for reviewing the amendment request.
  4. Click Start. Vault assigns you a Submit Amendment Request task.
  5. Click Complete on the Submit Amendment Request task banner to open the Submit Amendment Request dialog.
  6. Enter the Amendment Justification for requesting amendment to the closed Deviation.
  7. Click Complete. Vault assigns an Approve Amendment Request task to the selected QA Approver.

Approving Deviation Amendment Requests

When a Deviation Amendment Request is submitted, the selected QA Approver is assigned an Approve Amendment Request task to review the request.

Complete the following steps to approve a Deviation Amendment Request:

  1. Access the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions.
  2. Review the Deviation details and amendment request to determine whether to approve or reject the request.
  3. Click Complete on the Approve Amendment Request task banner to open the Approve Amendment Request dialog and select the appropriate verdict:
    • To approve the request and reopen the Deviation, select the Approve - Allow Amendment verdict, select Quality Amendment Request Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault updates the Deviation status to In Amendment and assigns a Complete Amendment Actions task to the user who created the Amendment Request.
    • To reject the request to amend the Deviation, select the Reject - Deny Request verdict, enter the Rejection Reason for denying the request, and click Complete. Vault notifies the user who created the Amendment Request that the request was denied.

Amending Deviations

When a Deviation Amendment Request is approved, the user who created the request is assigned a Complete Amendment Actions task to add information to the Deviation.

Complete the following steps to amend a Deviation after it has been closed:

  1. Access the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions.
  2. Expand the Amendment Comments section and click Edit () on the action bar.
  3. Enter Amendment Comments to provide additional clarity to the closed Deviation and click Save to save the comments.
  4. Add Attachments as needed. 
  5. Click Complete in the Complete Amendment Actions task banner to open the Complete Amendment Actions dialog. 
  6. Click Complete. Vault updates the Deviation status to In Amendment Approval and assigns an Approve Amendment task to the Amendment Request QA Approver.

Approving Deviation Amendments

When an Amendment Request Owner completes their Deviation amendments, Vault assigns the Amendment Request QA Approver an Approve Amendment task to review and approve the amendment. To complete the task, review the Amendment Request comments and approve or reject the request.

Complete the following steps to approve amendments to a Deviation:

  1. Access the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions.
  2. Review the changes made as part of the amendment to determine whether to approve or reject the amendment.
  3. Click Complete on the Approve Amendment task banner to open the Approve Amendment dialog and select the appropriate verdict:
    • If the amendment is satisfactory, select the Approve verdict, select Quality Amendment Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault updates the Deviation status to Closed.
    • If the amendment requires further work, select the Reject verdict, enter the Rejection Reason with the additional work that is required, and click Complete. Vault changes the Deviation status back to In Amendment and assigns a Complete Amendment Actions task to the Amendment Request Owner.