Manage CAPA Line Completion
Explanation
This activity is used for managing the actual action carried out to complete the
CAPA line. A person responsible for verification is identified and a target date
is set, then the person responsible for the action will add notes and set the
status to Action Completed.
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.
Prerequisites
A Corrective or Preventive action line should exist in the
Investigated status.
System Effects
As a result of this activity, the status of the Corrective or Preventive Action
line changes to
Action Completed.
Window
Corrective and Preventive Action
Corrective and Preventive Actions
Related Window Descriptions
Corrective and Preventive Action
Corrective and Preventive Actions
Procedure
Corrective and Preventive Action window
- Click the Actions tab and select a record.
- Click the Enter Action Data link to work from a dialog, or fill
in the fields on the line.
- Enter an appropriate note in the Action Notes field. Entering a value in this field is
required.
- In the Verification Responsible ID field, enter the ID of the
verification responsible person. Entering a value in this field is required.
- In the Verification Target Date field, enter a target
verification date. Entering a value in this field is required.
- Click OK.
- Right-click and then click Action. The status of the Corrective and Preventive Action record changes to
Action Completed. The system generates a time stamp for the completion date
as well as for the person who made the system state change.
Corrective and Preventive Actions window
- Enter an appropriate note in the Action Notes field. Entering a value in this field is
required.
- In the Verification Responsible ID field, enter the ID of the
verification responsible person. Entering a value in this field is required.
- In the Verification Target Date field, enter a target
verification date. Entering a value in this field is required.
- Click OK.
- Right-click and then click Action. The status of the Corrective and Preventive Action record changes to
Action Completed. The system generates a time stamp for the completion date
as well as for the person who made the system state change.
Note: if you want to revoke the completion, you can right-click and
then click Investigate. The
Action Completed Date and
Action Completed By
fields will be cleared.