Verifying Implementation

Once the CAPA action plans have been implemented, the verify implementation assignee receives email notification . Users with the appropriate roles have access to the workspace options on the CAPA/NC Workspace and/or CAPA Coordinator dashboard.

NOTE: Click the Change Task Owner link to assign this task to another user. For additional information, see Changing the Task Owner.

1. From the CAPA/NC Workspace, click the Verify Implementation link to the appropriate CAPA.
   Result: The Verify Implementation window is displayed.

NOTE: If the implementation due date needs to be extended, the implementer can request a due date extension. See Extending a Due Date for additional information.

2. Select either Acceptable or Not Acceptable.

• Acceptable - Verifies that all action plans and that the implementation can be closed.
• Not Acceptable - Initiates an additional step called Plan CAPA Implementation. This step allows the implementer to modify the action plans specified by the verifier.
• Click the Sign-off button.
  Result: The Sign-off window is displayed.
• 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 implementation 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, such as Perform Effectiveness Review or Plan CAPA Implementation, then the user will see the option to enter the next step.

NOTE: If the implementation verification is not acceptable, an email is sent to the CAPA Implementation Owner who then modifies the implementation plan. All information entered previously in the implementation is maintained. The Implementation Owner can view the approver’s notes from the Activity section of the implementation record: