Who is this for?
Approver - approving the CAPA in the Planning and Execution approval steps
How to do it
An approval applies in the Planning and Execution phases when the CAPA type requires it. When a CAPA type has more than one Approver, each assigned Approver repeats these steps.
Open the CAPA and select Approve.
In Action Confirmation, select Approve and Sign and enter your account credentials to capture the electronic signature.
When the Planning approval is complete, the CAPA proceeds to In Execution. When the Execution approval is complete, the CAPA proceeds to Pending Effectiveness Check.
Approving and signing the CAPA.
đNote: If the CAPA type does not require an effectiveness assessment (Assess effectiveness is off, configured in CAPA Type), the CAPA is completed on closure after the Execution approval rather than moving to Pending Effectiveness Check.
âThe electronic signature should be applied by the assigned Approver acting on their own credentials. Keep approver assignment aligned with the segregation of duties defined in your procedure (for example, the person who authored the CAPA should not be its sole approver).
đĄTip: Because Approval makes the document, actions and details read-only, resolve any last content questions latest before sending for approval. Once the CAPA is in Approval, a change means sending it back to before the review state.