What is the difference between the Responsible Person and the Responsible Users in a CAPA?

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Responsible Person

The Responsible Person is the user that has been assigned as responsible for the entire CAPA.

This user will be the one to sign off on the CAPA after the CAPA Plan has been executed and all Actions have been closed. 

In other words, the Responsible Person is the user who will be able to set the CAPA to Under Signing by QA.

While in Created and Implementing status the Responsible Person will be able to edit the CAPA.

 

Responsible User(s)

The Responsible User(s) are the users that have been assigned as responsible for executing a Custom Action in the CAPA.

These users will only be able to close the Custom Actions assigned to them and set them to closed. 

Responsible Users will not be able to edit the CAPA unless they are also assigned in another CAPA role such as Responsible Person, Approver, or QA.

  
Relevant for: Administrators / Managers / Regular Users.

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