When the Standalone CAPA Owner completes their CAPA plan, the Standalone CAPA QA Approvers must review and approve the CAPA plan. Once approved, the implementation process can begin.
The following diagram illustrates when CAPA plan approval occurs during the life of the Standalone CAPA:
Approving Standalone CAPAs as the QA Approver
When the Standalone CAPA Owner completes the CAPA plan, the Standalone CAPA QA Approvers are assigned QA Approve CAPA Plan tasks. All QA Approvers must approve the CAPA plan before the plan is considered final and implementation can begin. If at least one QA Approver rejects the CAPA plan, the Standalone CAPA is returned to the Owner for revision.
Complete the following steps to approve or reject a CAPA plan as the assigned QA Approver:
- Access the Standalone CAPA from the assigned task. Vault opens the Standalone CAPA and displays a task banner with the task due date and instructions.
- Click Complete on the QA Approve CAPA Plan task banner to open the QA Approve CAPA Plan dialog and select the appropriate verdict:
- Select the Approve verdict, select the Quality Plan Approval Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault performs the following actions and status changes to initiate the CAPA plan implementation process:
- The Standalone CAPA status is updated to CAPA Implementation.
- The status of each CAPA Action is updated to Implementation.
- A Complete Standalone CAPA Action Implementation task is assigned to the Owner for each CAPA Action.
- The status of each Effectiveness Check is updated to Pending Start Date.
- Select the Reject verdict, enter the Rejection Reason, and click Complete. Vault changes the Standalone CAPA status back to CAPA Planning and assigns the Owner a Complete CAPA Plan task.
- Select the Approve verdict, select the Quality Plan Approval Electronic Signature Approval Meaning, enter your User Name and Password, and click Complete. Vault performs the following actions and status changes to initiate the CAPA plan implementation process:
Approving Standalone CAPA Cancellation
When the Standalone CAPA Owner requests cancellation of the Standalone CAPA, the QA Approver is assigned an Approve Standalone CAPA Cancellation task. The QA Approver can either approve the cancellation and close the Standalone CAPA, or reject the cancellation and send the Standalone CAPA back to the Owner for revision.
Complete the following steps to approve a request to cancel a Standalone CAPA:
- Access the Standalone CAPA from the Complete CAPA Plan. Vault opens the Standalone CAPA and displays a task banner with the task due date and instructions.
- Review the Standalone CAPA details to determine whether to approve or reject the cancellation.
- Click Complete in the Approve Standalone CAPA Cancellation task banner to open the Approve Standalone CAPA 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 Standalone CAPA status to Cancelled.
- To reject the cancellation, select the Reject Cancellation verdict, enter the Rejection Reason, and click Complete. Vault changes the Standalone CAPA status back to CAPA Planning and assigns a Complete CAPA Plan task to the Standalone CAPA Owner.