In more complex CAPAs, where many Actions are to be carried out, the CAPA can be in Implementing Status for a long period of time.
This means that before the CAPA reaches Under Signing by QA many weeks or even months may pass. If QA rejects the CAPA and indicates that many of the Actions need to be repeated this can become problematic seeing that many of the Actions may have been carried out a long time ago.
In order to avoid running into this type of complication, it may be a good idea to modify CAPA Module settings and activate QA must sign off on all CAPA Actions.
Activating Action Sign off for QA
- Go to CAPAs > Module Settings.
- Go to Signature Settings.
- Turn the Action Sign off for QA switch ON.