Can a CAPA Action be re-opened?

CAPA Actions can be opened in three different scenarios, that are related to how the Module Settings have been configured. These settings are: 

• Action Sign off for QA
• Allow reopening of CAPAs

Re-opening a CAPA Action with the relevant Module Settings turned OFF

If you haven't turned any of these options ON, the moment when you will be able to re-open CAPA Actions will be during the Under Signing by QA:

1. QA chooses to Reject as QA

After the pop-up appears

2. A reason needs to be provided
3. You can select what Custom Actions and what Documents you would like to have reopened
4. Save

Re-opening a CAPA Action with "Action Sign off for QA" turned ON

After the Responsible User has completed the Action, the QA will have the option of Accepting or Denying the performed Action.

1. QA decided to deny a CAPA Action

2. Introduce electronic signature credentials: User and Password. 
3. A reason must be provided
4. Sign off

The Action will go from Pending Approval back to Open.

Re-opening a CAPA Action with "Allow reopening of CAPAs" turned ON

If you have this option turned ON in your Module Settings, after the CAPA has been closed, you can still click on the Status to see the dropdown menu with the Reopen CAPA option.

1. Click on Reopen CAPA

2. Introduce electronic signature credentials: User and Password. 
3. Provide a reason
4. Select what status the CAPA will be after reopening
5. Choose what Custom Actions or Documents will be reopened
6. Sign off