Implementing and Completing Action Plans

Once the CAPA investigation is approved, the user(s) assigned to the associated action plan(s) receives email notification . Users with the appropriate roles have access to the workspace options on the CAPA/NC Workspace and/or CAPA Coordinator dashboard.

1. From the CAPA/NC Workspace, click the Implement Action Plans link to the appropriate CAPA.
   Result: The Implement Action Plans window is displayed.

2. Review the action plan information.
3. In the Is Plan Complete? field, select either Yes or No and enter a comment.

• Yes - If Yes is selected, specify whether or not there is confirmation and objective evidence that the specific requirements have been fulfilled. The Comment field is required if Yes is selected.
• No - If No is selected, complete the implementation.

4. Complete the checklist, if applicable.
5. Click the Sign-off button.
   Result: The Sign-off window is displayed.
6. If a checklist was assigned to the action plan, answer the checklist questions. The Comment field is required if No is selected for any of the questions.
7. 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, such as Include in Effectiveness Review Plan or Verify Implementation, then the user will see the option to enter the next step.