CAPA: Created status

  • Updated

Editing the CAPA while in Created status

While the CAPA is in Created status it can be edited by either of the following Users defined in the CAPA: Creator, Responsible Person, Approver, and QA.

Users that have been defined as Responsible Users for CAPA Actions will only be able to edit the CAPA if they have also been assigned one of the above-mentioned roles (Creator, Responsible Person, Approver, or QA) or if they are Administrators.

Practically all CAPA details can be edited at this point (roles, due date, title, etc.) except the name of the Creator of the CAPA. This role is not introduced manually, it is stored by the system the moment the User clicks on the +  icon to create the new CAPA in the CAPAs Listings Page.

Custom Actions and Update Documents Actions can be added, edited, and deleted while the CAPA is in Created status. More on this here: How to add a Custom Action to a CAPA, How to add an Update Documents Action to a CAPA and Can CAPA Actions be edited or deleted?.

 

Setting the CAPA to Under Signing by Approver

Once the CAPA has been created and all relevant information has been included, the CAPA is ready to move forward in the CAPA workflow. 

There are only two Users that can set the CAPA to Under Signing by Approver, these are Creator and Responsible Person. They can be one and the same person.

 

Changing status from Created to Under Signing by Approver

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

CAPA_Created_status_SC1.png

  1. The Creator or Responsible Person will have to sign off electronically.
  2. Save changes.

CAPA_Created_status_SC2.png

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

The CAPA will go to Under Signing by Approver status.

 

  Relevant for: Administrators / Managers / Regular Users.

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