Amend a Closed QMS Record

Once a QMS record is closed, it represents a finalized record that has been approved and electronically signed off on. To maintain compliance, only limited actions can be taken during an amendment on a closed QMS record.

You can request to amend a QMS record (Audit, Change Control, Deviation, Finding, or Standalone CAPA) after it is closed to add comments, attachments, and/or library references.

Request an Amendment

To request an amendment to a QMS record:

1. Navigate to the Closed (or Pending Finding Closure) QMS record you want to amend.

2. Select Request Amendment from the Workflow menu.

   

3. Select the QA Approver(s) responsible for reviewing the amendment request and the amendment itself and click Start.

   

4. You will receive a task to Submit the Amendment Request. Click Complete to complete the task.

   

5. Enter the Amendment Justification including what you would like to amend and why. Then click Complete.

   

   A task is sent to the QA Approver(s) to approve the amendment request.

Approve an Amendment Request

To approve an amendment request for a QMS record:

1. Click the link in the Approve Amendment Request task.

   

2. Navigate to the Workflow Timeline and review the details of the amendment request to determine wheter to approve or reject the task.

3. Click Complete to complete the task.

   

4. Select your Verdict and click Complete.

   • To approve the request and allow edits to the QMS record, select Approve - Allow Amendment, provide your eSignature, and click Complete.

     

     The QMS record changes to In Amendment and a task is sent to the Amendment Requestor.

   • To reject the request, select Reject - Deny Request, provide a Rejection Reason, and click Complete.

     

     The Amendment Requestor is notified that the request was denied.

Amend a QMS Record

The only changes that are allowed during an amendment are adding comments, attachments, and/or library references.

To amend a QMS record after the amendment request has been approved:

1. Click the link in the Complete Amendment Actions task.

   

2. To add comments, click Edit ().

   

3. Open the Amendment Comments section, enter comments to provide additional clarity to the Closed (or Pending Finding Closure) QMS record and click Save.

   

4. To add library references, open the Library References section and click + Create. Select the document and version you want to add to the record. Then click Save. 

5. To add attachments, open the Attachments section and click Upload to add one or more attachments to the record.

   

   Note If a library reference or attachment was added by mistake, reach out to QA to remove it. Deletion is restricted during amendment so that library references/attachments that were previously part of the approved record aren’t deleted.

6. When you’re finished making the amendments, click Complete to complete the task.  

   

7. Click Complete.

   

   The QMS record changes to In Amendment Approval and a task is sent to the QA Approver(s).

Approve an Amendment

To approve an amendment to a QMS record:

1. Click the link in the Approve Amendment task.

   

2. Review the added comments, attachments, and/or library references to determine whether to approve or reject the amendment.

3. Click Complete to complete the task

   

4. Select your Verdict and click Complete.

   • If the amendment is satisfactory, select Approve, provide your eSignature, and click Complete.

     

     The QMS record changes to Closed (or Pending Finding Closure).

   • If the amendment requires further work, select Reject, provide a Rejection Reason with the additional work that is required, and click Complete.

     

     The QMS record changes back to In Amendment and a task is sent to the Amendment Owner to make the requested changes.