CAPA: Effectiveness Pending Approval status

Editing a CAPA while in Effectiveness Pending Approval status 

A CAPA Effectiveness Pending Approval cannot be edited.

Changing CAPA status

When a CAPA reaches Effectiveness Pending Approval status only QA can decide to either Close the CAPA or to Reject Effectiveness Check.

Setting CAPA to Closed

1. In the CAPA Details Page, click on the Effectiveness Pending Approval status button.
2. Select Set to Closed.

In the Set to Closed window:

1. Sign off electronically 
2. Save.

The system will then give the following notification: CAPA updated successfully.

Rejecting Effectiveness Check

QA can also decide to Reject the Effectiveness Check, in this case CAPA will be pushed back to Effectiveness Check Pending.

1. On the CAPA Details Page, click the Effectiveness Pending Approval status button.
2. Select Reject Effectiveness Check.

In the CAPA Reject window:

1. QA must give a reason for rejecting the Effectiveness Check.
2. Save.

QA will then be asked to confirm. Finally, the system will give the notification: CAPA updated successfully.

After this, CAPA will go back to Effectiveness Check Pending status. The Responsible Person for the CAPA will receive an email notification indicating the CAPA Effectiveness Check was rejected by QA and including the reasons given by QA.

The reasons will also be available in the CAPA Audit Trail Tab. 

The Responsible Person can then amend accordingly, update the Effectiveness Check Conclusion and once everything is in order set the status again to Effectiveness Pending Approval.