Immutable audit trails, end-to-end traceability, and exportable evidence mapped to FDA, ISO, IEC, and HIPAA.
Electronic records & electronic signatures.
Quality management for medical devices.
Software life cycle for medical devices.
Application of risk management to medical devices.
Security & privacy for PHI in covered workflows.
Security controls & monitoring alignment.
Every event is hash-chained (CAL) with actor, timestamp, rationale, and prior-hash for tamper evidence.
TSE graph links requirements, design, tests, SOPs, CAPAs—enabling end-to-end coverage.
CIS/SID produce transparent factor breakdowns (B, C, P, R, A, D) with weights and history.
Configurable approval steps (who/when/intent) meet Part 11 expectations for e-signatures.
One-click export generates a sealed package: change log, linked evidence, and approval chain.
RBAC, SSO, session policies, and export redaction support HIPAA/NIST security objectives.
Yes. Approvals capture signer identity, intent, and meaning with time-stamp and hash chain link.
Yes. Generate sealed PDF/CSV/JSON bundles with a manifest and checksum for integrity.
Deploy on customer-controlled infrastructure; exports support redaction and scoped evidence sharing.
Weights are configurable and documented; breakdown is explainable and trace-linked to evidence.