21 CFR Part 11 Audit Active
Ingest Protocol

Candidate Patient Cohort & Screening

Synthea FHIR R4 patient records evaluated with verifiable citation contracts and fail-closed safety.

Export CTMS / EDC CSV

Select protocol to evaluate cohort against machine-decomposed inclusion/exclusion tree.

Screening TelemetryFail-Closed Verification Engine
Eligible0
Ineligible0
Incomplete / Unknown0