Create an Effectiveness Check

The Change Control, Deviation, or Standalone CAPA Owner is responsible for creating Effectiveness Checks during change planning, deviation, or Standalone CAPA assessment.

Complete the following steps to create an Effectiveness Check:

  1. In the Change Control or Deviation record, expand the Effectiveness Checks section.
  2. Click Create to open the Create Effectiveness Check page. 
  3. Enter the Effectiveness Check Title and a Description of the activities required to check for effectiveness of the executed plan.
  4. 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. 
  5. Enter the Current Due Date, which is the date the Effectiveness Check must be completed and approved. 
  6. Click Save to save the record and open the Effectiveness Check page.
  7. In the Team section, click Manage Team. 
  8. 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.
  9. Click Save to save the selected team members. Vault updates the Effectiveness Check status to Initiated.
  10. Optional: Add Library References or Attachments as needed.