CAPA: Approve Implementation Status

Editing the CAPA while in Approve Implementation status

A CAPA cannot be edited while in Approve Implementation status.

Setting the CAPA to Implementing or Rejecting the CAPA

Once the CAPA reaches Approve Implementation status, QA can go over all the details of the CAPA, which are to be found in the different tabs on the CAPA Details Page.

QA can then decide to either set the CAPA to Implementing or to Reject the CAPA.

If there is more than one QA and the Sign off by all QA persons required switch has been turned ON in Module Settings, then all QA persons must sign off before the CAPA goes to Implementing status.

Set to Implementing

1. On the CAPA Details Page, click the Approve Implementation status button.
2. Set to Implementing.

In the set to Implementing window, QA must then:

1. Introduce electronic signature credentials: User and Password. 
2. Sign.

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

If there is more than one QA and the Sign off by all QA persons required switch has been turned ON in Module Settings, then all QA persons must sign off before the CAPA goes to Implementing status.

Reject the CAPA

If QA considers that the CAPA needs to be amended before it reaches Implementing status, he/she can reject the CAPA. 

1. On the CAPA Details Page, click the Approve Implementation status button.
2. Set to Reject to Created.

In the CAPA Reject window, QA must then:

1. Give a Reason for Rejecting the CAPA.
2. Save.

It is not necessary to sign off electronically when rejecting a CAPA.

Finally, QA must confirm the 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 QA 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 QA persons have signed off already.