Compliant intake The regulated front door. Complaints, cases, and post-market signals captured once, classified (with AI suggestions, where you choose to turn them on), and routed to a qualified human who makes the decision.
COMPLAINT · CMP-30981 QA SIGN-OFF
Illustrative record Choose a step or evidence row to inspect
Triage Optional AIClassification and route suggested, with the reasoning shown Review Medical reviewer confirms or overrides the route Sign Part 11 e-signature on the reportability decision Close Case closes with its full history CMP-30981 Complaint captured from the contact center Logged ROUTE-07 Routing reasoning recorded Reviewable MDR-112 Reportability assessed In review
STEP 03 · Sign Current in example
Part 11 e-signature on the reportability decision
Inspection only. The example record and its signature state stay unchanged. Awaiting signature — Quality Assurance Meaning: Approval · Re-authentication required · Hash-chained on signing AWAITING SIG Illustrative record: a complaint where AI, configured for this customer, suggests a route with visible reasoning, and a person decides.