Closing CAPA Actions

This article is only relevant for CAPAs in which Actions have been defined. In a simple workflow CAPA, no Actions have been created, therefore it is not relevant to address how Actions are closed and what happens when they are.

Before a CAPA can proceed from Implementing status to Under Signing by QA all Actions must be marked as closed.

How the Action is closed depends on the type of Action as well on system settings.

Update Document Actions will close automatically once the Documents included in the Action have all completed a full approval Cycle (from Draft to Published). 

Custom Actions require that the Responsible User marks the Action as completed.

Depending on system settings it may be required that QA signs off on all Actions before these are marked as closed. This will only be the case for Custom Actions, it is not applicable to Update Documents Actions, in this case, the system verifies that the Documents have gone through the entire approval cycle.

Closing Actions 

Closing Custom Actions by Responsible User

The Responsible User of the Custom Action must mark the Action as closed. This can be done from the Actions Tab on the CAPA Details Page.

1. Go to the Actions Tab of the CAPA Details Page.
2. Click on the Actions button
3. Click on Close Action

In the Update Action window:

1. Introduce electronic signature credentials: User and Password. 
2. Describe the Actions Performed.
3. If relevant, upload files.
4. Sign.

If it is not required for QA to sign off on all Actions then you will get the message: Action closed successfully. In the Action Tab of the CAPA Details Page, the Action will appear as Closed in the Status Column. If there is more than one Responsible User the Custom Action will not be set to Closed until all Responsible Users mark the Task as completed.

If system settings require that QA sign off on all Actions, you will get the message: Action status set to pending approval successfully. In the Action Tab of the CAPA Details Page the Action will then appear as Pending Approval in the Status column. If there is more than one Responsible User the Custom Action will not be set to Closed until all Responsible Users mark the Task as completed.

QA Action Approval

QA can approve Custom Actions from the Actions Tab in the CAPA Details Page.

1. Go to the CAPA Actions Tab.
2. Check which Actions are Pending Approval in the Status column.
3. Click on the Actions Button
4. Accept or Deny the Action.

If QA Denies the Action the Update Action window will include a Reason field, QA must:

1. Introduce electronic signature credentials: User and Password. 
2. Give a Reason for rejecting the Action.
3. Sign.

The Custom Task will reopen and the Responsible User will then have to repeat the Action taking into consideration the reasons given by QA. Once the Action has been completed the Responsible User will then have to set the Action as closed once again.

If QA Accepts the Action then the Update Action window will appear without a reason field, QA must:

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

QA will then get the message: Action closed successfully. Thereafter the Custom Action will appear as Closed in the Actions Tab.

If there is more than one QA Person in the CAPA, it is not necessary that they all sign off. As soon as one QA person Approves the Custom Action, it will be Closed and disappear from the Dashboard of all QAs assigned to this CAPA.

Once all Actions are closed in a CAPA, the Responsible Person will be able to set the CAPA to Under Signing by QA.

Update Documents Actions

In this case, the Actions will be completed as soon as the Documents included in the Action have gone through a full approval cycle. The Action will be marked automatically as closed by the system once this happens.

It is not necessary for QA to sign off on this Action even if the Action Sign off for QA switch is turned ON.