Editing the CAPA while in Under Signing by Approver status
A CAPA cannot be edited while in Under Signing by Approver status.
Setting the CAPA to Implementing or Rejecting the CAPA
Once the CAPA reaches Under Signing by Approver status, the Approver(s) can go over all the CAPA details, these are to be found in the different tabs in the CAPA Details Page.
Approver(s) can then decide to either set the CAPA to Implementing or to Reject the CAPA.
If there is more than one Approver and the Sign off by all Approvers required switch has been turned ON in Module Settings, then all Approvers must sign off on the CAPA before the CAPA goes to Implementing status.
Set to Implementing
- In the CAPA Details Page, click on the Under Signing by Approver status button.
- Set to Implementing.
Approver must then:
- Sign off with electronic signature.
- Save.
The system will then give the following notification: CAPA Updated successfully.
If there is only one Approver then the CAPA will go to Implementing status. If there is more than one Approver and it is required that they all sign off, then the CAPA will go to Implementing status as soon as the last Approver signs off on the CAPA.
Reject the CAPA
If the Approver considers that the CAPA needs to be amended before it reaches Implementing status, he/she can reject the CAPA.
- In the CAPA Details Page, click on the Under Signing by Approver status button.
- Set to Reject as Approver.
Approver must then:
- Give a Reason for Rejecting the CAPA.
- Save.
It is not necessary to sign off electronically when rejecting a CAPA.
Finally Approver must confirm rejection of the CAPA.
The system will then give the following notification: CAPA Updated successfully.
The CAPA will go back to Created status.
If there is more than one Approver it is only necessary for one of them to reject the CAPA and it will go back to Created status. This will be the case even if other Approvers have signed off already.