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CAPA: Under Signing by Approver status

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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 Approve Implementation or Rejecting the CAPA

Once the CAPA reaches Under Signing by Approver status, the Approver(s) can go over all the details of the CAPA, which are to be found in the different tabs in the CAPA Details Page.

 

CAPA_Under_Signing_by_Approver_status_SC1.png

 

Approver(s) can then decide to either set the CAPA to Approve Implementation 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 before the CAPA goes to Approve Implementation status.

Set to Approve Implementation

  1. In the CAPA Details Page, click on the Under Signing by Approver status button.
  2. Set to Approve Implementation.

CAPA_Under_Signing_by_Approver_status_SC2.png

In the Set to Approve Implementation window, the Approver must then:

  1. Sign off. 
  2. Save.

CAPA_Under_Signing_by_Approver_status_SC3.png

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

If there is only one Approver then the CAPA will go to Approve Implementation status. If there is more than one Approver and it is required that they all sign off, then the CAPA will go to Approve Implementation 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 Approve Implementation status, he/she can reject the CAPA. 

  1. In the CAPA Details Page, click on the Under Signing by Approver status button.
  2. Set to Reject as Approver.

CAPA_Under_Signing_by_Approver_status_SC4.png

In the CAPA Reject window the Approver must then:

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

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

CAPA_Under_Signing_by_Approver_status_SC5.png

Finally, the Approver must confirm rejection of the CAPA.

CAPA_Under_Signing_by_Approver_status_SC6.png

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.

  Relevant for: Administrators / Managers / Regular Users.

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