Close a Major or Critical Deviation

Once the Deviation Owner completes the investigation and the appropriate details and records are documented, the Owner can send the Deviation to the QA Approver for final approval. After the QA Approver completes the final QA approval, the Deviation is automatically closed.

If any CAPA Actions or Effectiveness Checks are required, they are completed by their respective Owners after the Deviation is closed.

Note External Deviations (with any rating) follow the process for Minor or External Deviations

To initiate final approval and closure for a Major or Critical Deviation:

  1. Access the Deviation from the assigned task. Vault opens the Deviation and displays a task banner with the task due date and instructions.
  2. Click Complete in the Complete Investigation & CAPA Plan task banner to open the Complete Investigation & CAPA Plan dialog.
  3. Click Complete in the dialog. Vault performs the following actions and status changes:
    • The Deviation status is updated to In Final Approval.
    • A Complete Final Approval task is assigned to the Deviation QA Approver.
    • The status of CAPA Actions and Effectiveness Checks are updated to Pending Review.