An optional investigation assistant can produce a provisional severity analysis, impact assessment, 5-Whys skeleton, CAPA recommendation and similar-deviation context for human review.

Current scope: implemented for controlled synthetic-data demonstrations, behind an organization setting. It is not generally available for real customer quality records. Real-data use needs the applicable data-use arrangements and release readiness.

AI generation and section-review events have attributed audit evidence within the implemented workflow. The human reviews and applies any content through ordinary record controls; the assistant never signs or closes a record.

This is deviation-investigation assistance, not complaint AI, an automatic inbox reader, or automatic deviation creation from production events.