Working with Extension Requests

For many different records created during the Change Control, Deviation, and Standalone CAPA processes, you must create Extension Requests to request to change their due date. When an Extension Request is created, the QA Approver is assigned an Extension Request Approval task to review and approve or reject the Extension Request.

You can create Extension Requests for any of the following records:

  • CAPA Actions
  • Change Actions
  • Change Controls
  • Deviations
  • Standalone CAPAs
  • Effectiveness Checks
  • Investigations

Creating Extension Requests

Complete the following steps to create an Extension Request:

  1. Expand the Extension Request section and click Create to open the Create Extension Request page.
  2. Enter the Title of the Extension Request. 
  3. Select a Revised Due Date for when you anticipate the source record can be completed. If the extension is approved, the Current Due Date is updated to this date.
  4. Enter a Justification for why an extension is needed. 
  5. Click Save to save the information.
  6. Expand the Team section and click Manage Team.
  7. Search for and select the QA Approvers responsible for reviewing the Extension Request. 
  8. Click Save to save the QA Approvers. Vault updates the Extension Request status to In Approval and assigns an Extension Request Approval task to the selected QA Approvers.

Approving Extension Requests

When an Extension Request is created, the Extension Request QA Approver is assigned an Extension Request Approval task. To complete the task, approve the request and update the due date, reject the request without updating the due date, or reject the request and return it to the Owner for revision.

Complete the following steps to approve an Extension Request:

  1. Access the Extension Request from the assigned task. Vault opens the Extension Request and displays a task banner with the task due date and instructions.
  2. Review the Extension Request details and click the source record link to open the record the extension request was created from, if needed. 
  3. Click Complete in the Extension Request Approval task banner to open the Extension Request Approval dialog and select the appropriate verdict:
    • To approve the extension request and update the due date, select the Approve - Update Due Date verdict, select the Quality Extension Approval Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the Extension Request status to Closed and updates the source record’s Current Due Date to the Requested Due Date from the Extension Request. Vault updates any task due dates accordingly for the associated source record. 
    • To reject and close the extension request, select the Reject - Do Not Update Due Date verdict, enter the Rejection Reason for why you are rejecting the request, and click Complete. Vault changes the Extension Request status to Closed. 
    • To reject the extension request and return it to the Owner to update and resubmit, select the Reject - Update Request and Resubmit verdict, enter the Rejection Reason for why you are rejecting the request and what the Owner should update before resubmitting the request, and click Complete. Vault changes the Extension Request status to Update Request and assigns an Update Request task to the Extension Request Owner.

Updating Rejected Extension Requests

If an Extension Request is rejected and returned for revision, the Extension Request Owner is assigned an Update Request task. To complete the task, update the Extension Request and resend it for approval, or cancel the Extension Request. A canceled Extension Request cannot be reopened.

Complete the following steps to update a rejected Extension Request:

  1. Access the Extension Request from the assigned task. Vault opens the Extension Request and displays a task banner with the task due date and instructions.
  2. Expand the Details section and click Edit () on the action bar.
  3. Edit the Revised Due Date and Justification as needed according to the Update Request task instructions.
  4. Click Save to save the updated information.
  5. Click Complete on the Update Request task banner and select the appropriate verdict:
    • To send the updated Extension Request back for approval, select the Complete verdict and click Complete. Vault updates the Extension Request status to In Approval and assigns an Extension Request Approval task to the selected QA Approvers.
    • To cancel the Extension Request, select the Cancel verdict and click Complete. Vault updates the Extension Request status to Canceled.