Effectiveness Checks allow you to monitor the effectiveness of a change after it is implemented. In the case of a Deviation, an Effectiveness Check evaluates the effectiveness of the CAPA plan.
To create an Effectiveness Check:
In the Change Control or Deviation record, click Effectiveness Checks, then click Create.
Enter the Title of the Effectiveness Check.
Enter a Description of the activities required to check for effectiveness of the executed plan.
Enter the Start Date on which Vault will automatically initiate the Complete Effectiveness Check task. We recommend entering a Start Date later than the Change Control or Deviation Current Due Date, because Effectiveness Checks are completed after the associated Change Control or Deviation is closed.
Enter the Current Due Date, which is the date the Effectiveness Check must be completed and approved.
Click Save to save the record and open the Effectiveness Check page.
In the Team section, click Manage Team.
Select the Owner responsible for completing the effectiveness check and one or more QA Approvers responsible for approving the effectiveness check completion. A QA Approver cannot be the same user as the Owner. Vault defaults the QA approver(s) to those already on the Deviation team.
Click Save to save the selected team members. Vault updates the Effectiveness Check status to Initiated.
Optional: Add Library References or Attachments as needed.
