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

  1. Click the Actions tab and select a record.
  2. Click the Enter Action Data link to work from a dialog, or fill in the fields on the line.
  3. Enter an appropriate note in the Action Notes field. Entering a value in this field is required.
  4. In the Verification Responsible ID field, enter the ID of the verification responsible person. Entering a value in this field is required.
  5. In the Verification Target Date field, enter a target verification date. Entering a value in this field is required.
  6. Click OK.
  7. 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

  1. Enter an appropriate note in the Action Notes field. Entering a value in this field is required.
  2. In the Verification Responsible ID field, enter the ID of the verification responsible person. Entering a value in this field is required.
  3. In the Verification Target Date field, enter a target verification date. Entering a value in this field is required.
  4. Click OK.
  5. 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.