Working with Standalone CAPA Actions

Corrective and Preventive Actions, or CAPAs, allow you to track actions taken to either correct or prevent issues found in relation to a Standalone CAPA. The CAPA Owner is responsible for managing and implementing the action, and the QA Approver is responsible for reviewing and approving the action implementation.

Creating Standalone CAPA Actions

If a Standalone CAPA’s CAPA Required field is set to Yes, at least one CAPA Action must be created and in the Initiated state or later before the Standalone CAPA can be sent for approval. 

Complete the following steps to create a CAPA Action for a Standalone CAPA:

  1. In the Standalone CAPA record, expand the CAPA Actions section, and click Create. The Create CAPA Action page is displayed.
  2. Enter the Title of the CAPA Action.
  3. Enter a Description of the actions required to implement the CAPA Action.
  4. Select whether the Action Type is a Corrective Action or a Preventive Action.
  5. Select the Category of the CAPA Action.
  6. Select the Current Due Date the CAPA Action execution and approval must be completed. You cannot edit this date after you create the CAPA Action and must create an Extension Request to update this date.
  7. Click Save. Vault creates the CAPA Action record with the status of Define Team and opens the CAPA Action page.
  8. Expand the Team section and click Manage Team.
  9. Search for and select the Owner responsible for implementing the action and one or more QA Approvers responsible for approving the action implementation. A QA Approver cannot be the same user as the Owner. 
  10. Click Save. Vault saves the team information and updates the CAPA Action status to Initiated.

Completing Standalone CAPA Actions

When a Standalone CAPA is closed, the Owners of any associated CAPA Actions are assigned Complete CAPA Implementation tasks. To complete the task, document the actions taken to implement the CAPA.

If you need additional time to complete a CAPA Action, create an Extension Request to request a later due date.

Complete the following steps to complete a CAPA Action:

  1. Access the CAPA Action from the assigned task. Vault opens the CAPA Action and displays a task banner with the task due date and instructions.
  2. Review the CAPA Action details and implement the CAPA as instructed.
  3. Expand the Actions Taken section and click Edit () on the action bar. 
  4. In the Details section, document the actions taken to implement the CAPA and any other relevant information. 
  5. Optional: Add Library References or Attachments as needed.
  6. Click Save to save the information.
  7. Click Complete in the Complete CAPA Implementation task banner to open the Complete CAPA Implementation dialog and select the appropriate verdict:
    • To complete the CAPA Action, select the Complete verdict and click Complete. Vault changes the CAPA Action status to In Approval and assigns an Approve CAPA Implementation task to the QA Approver.
    • To request cancellation of the CAPA Action, select the Request Cancellation verdict, enter the Cancellation Reason, and click Complete. Vault changes the CAPA Action status to Pending Cancellation and assigns an Approve CAPA Action Cancellation task to the QA Approver.

Approving Standalone CAPA Actions

When a CAPA Action is completed, Vault assigns an Approve Standalone CAPA Implementation task to the QA Approver of the CAPA Action. The QA Approver can approve and close the CAPA Action or reject and return it to the CAPA Action Owner for revision. 

Complete the following steps to approve a CAPA Action:

  1. Access the CAPA Action from the assigned task. Vault opens the CAPA Action and displays a task banner with the task due date and instructions.
  2. Review the CAPA Action details to determine whether to approve or reject it.
  3. Click Complete on the Approve CAPA Implementation task banner to open the Approve CAPA Implementation dialog and select the appropriate verdict:
    • To approve and close the CAPA Action, select the Approve verdict, select Quality Implementation Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the CAPA Action status to Closed.
    • If the CAPA Action requires further work, select the Reject verdict, enter a Rejection Reason for what further work is required, and click Complete. Vault changes the CAPA Action status back to In Implementation and assigns a Complete CAPA Implementation task to the CAPA Action Owner.

Approving Standalone CAPA Action Cancellation

When the CAPA Action Owner requests cancellation of the CAPA Action, the QA Approver is assigned an Approve CAPA Action Cancellation task. To complete the task, approve the cancellation and close the CAPA Action, or reject the cancellation and send the CAPA Action back to the Owner for revision.

Complete the following steps to approve a request to cancel a CAPA Action:

  1. Access the CAPA Action from the assigned task. Vault opens the CAPA Action and displays a task banner with the task due date and instructions.
  2. Review the CAPA Action details to determine whether to approve or reject the cancellation.
  3. Click Complete in the Approve CAPA Action Cancellation task banner to open the Approve CAPA Action Cancellation dialog and select the appropriate verdict:
    • To approve the cancellation, select the Approve Cancellation verdict, select Cancellation Approval for the Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault changes the CAPA Action status to Canceled. 
    • To reject the cancellation, select the Reject Cancellation verdict, enter the Rejection Reason, and click Complete. Vault changes the CAPA Action status back to In Implementation and assigns a Complete CAPA Implementation task to the CAPA Action Owner.