This activity is used to manage the evaluation of the effectiveness of a CAPA action line, and is usually done when a specified amount of time is elapsed since the CAPA action line has been verified.
Before the evaluation is started a person responsible for the effectiveness evaluation must be identified and an effectiveness target date can be set. To evaluate the effectiveness of a CAPA action line click Determine Effectiveness in the Actions section on the Corrective and Preventive Action page or on the Corrective and Preventive Action Lines page. Add verification notes and enable Set Status to Effectiveness Determined. Then click OK.
If you want to revoke an effectiveness determined action line click Revert in the Actions section on the Corrective and Preventive Action page or on the Corrective and Preventive Action Lines page. If the CAPA is closed, you need to reopen it first.
This activity contains a security checkpoint which can be activated by an administrator. With an activated security checkpoint on a function it is necessary to authenticate the user again in order to fulfill the function. Additionally, whenever a security checkpoint is successfully passed, a security checkpoint log is written creating an audit trail of what is done.
A Corrective and Preventive Action line should exist in the Verified status.