Who is this for?
Author - sending for review and finalizing the draft
Reviewer - completing the review
Owner - additional review actions (route, send back, close review, archive, manage CAPAs)
How to do it
Send the Quality Event for review (Author)
Once drafting the document, Vigilance Reporting and Quality Event Access are complete, and all required fields are set, Send for review becomes available.
Ensure the document content is complete, then select Send for review.
If the Quality Event has no generated CAPA, or a linked CAPA that is not yet closed, a justification and electronic signature are required to progress.
The workflow moves to Review.
Complete the review (Reviewer)
The reviewer has a review task for the Quality Event under Notifications and on the My Work page. Open the Quality Event.
The reviewer has full edit access to the document content and properties. Use the Check Out button to edit the document.
After completing the review, select Mark review as completed. The action completes without a further signature, and the workflow displays Review Closed.
Marking the review as completed.
Complete the draft before approval (Author)
Once the review is completed, the Quality Event is assigned to the Author to finalize the draft. Use the Check Out button to edit the document.
Once completed, select Send for approval.
The Send for approval action after review completion.
Owner review actions
While a Quality Event is in review, the Owner's menu provides additional actions:
Route for Another Review - send the Quality Event for a further review cycle.
Send Back to Assessment - return the Quality Event to Assessment; prior review records are retained.
Close Review - the Owner closes the review with a justification and electronic signature; the state changes to Review Closed. A Change Summary can be added, and the justification is captured in the Audit Trail.
Archive - archive the Quality Event (see Reopening a Quality Event).
Managing CAPAs - Link or unlink an existing CAPA (see Assessing a Quality Event).
The Owner's menu of additional review actions.
❗Review provides an independent check on the record before approval. Make sure reviewers are competent for the subject matter and, where your SOP calls for it, independent of the work under review.
💡Tip: If content isn't ready, use Send Back to Assessment rather than pushing an incomplete record toward approval. Prior review records are retained, so nothing is lost.