Verifying/Validating Action Plans

Once the CAPA is investigated and the action plans have been created, the action plan approver assignee receives email notification . A Verify/Validate Action Plan task will also be routed to the assigned user if Re-plan Implementation is selected during the Implementation phase. The user can access the workspace options and tasks from the CAPA Coordinator or CAPA/NC Workspace dashboard. The example below illustrates a Verify/Validate Action Plan task from the Investigation phase.

NOTE: The Verify/Validate Action Plans task is optional and must be enabled in the Verify CAPA Initiation task policy.

1. From the CAPA/NC Workspace, click the Verify/Validate Action Plans - Investigation link to the appropriate CAPA.
   Result: The Verify/Validate Action Plans - Investigation window is displayed.
2. Specify whether or not any of the actions adversely affect the safety and performance of the product or adversely affect the ability to meet applicable regulatory requirements.
   1. Yes - If Yes is selected, a Verification/Validation Failed? field must be checked for at least one action plan. Once a checkbox has been checked, a Verification/Validation Comment is required for that action plan.
   2. No - If No is selected, the action plans will be approved upon sign-off.
3. Enter a comment, if necessary.
4. Click the Sign-off button.
   Result: The Sign-off window is displayed.
5. Enter your user ID and password and then click the Sign-off button.
   Result: The Result window is displayed. The Result window is a window that displays after sign-off and asks the user where they would like to go next, such as to the CAPA Detail or back to the Portal Page. If the user is assigned the role for the next step in the workflow, then the user will see the option to enter the next step.

NOTE: If any of the action plans are failed for a Verify/Validate Action Plan-Investigation task, an email is sent to the CAPA Investigator who then repeats the CAPA investigation. If any of the action plans are failed for a Verify/Validate Action Plan-Implementation task, an email is sent to the CAPA Investigator who then repeats Plan CAPA Implementation. All previously entered information is maintained.