This activity is used to investigate a CAPA action line and release it for action completion. Before the investigation is started a person responsible for investigation must be identified and an investigation target date can be set.
To investigate a CAPA action line click Investigate in the Actions section on the Corrective and Preventive Action page or on the Corrective and Preventive Action Lines page. Add investigation notes, enter a person responsible for the completion of the action and enable Set Status to Investigated. Also an action target date can be added. Then click OK.
If you want to revoke an investigated action line click Revert in the Actions section on the Corrective and Preventive Action page or on the Corrective and Preventive Action Lines page.
This activity contains a security checkpoint that can be activated by an administrator. With an activated security checkpoint on a function it is needed 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 CAPA action line must exist in the Released status.
As a result of this activity, the status of the CAPA action line is changed to Investigated.