Secure access to your compliance environment. All sessions are authenticated, time-stamped, and recorded under 21 CFR Part 11 electronic records requirements.
21 CFR Part 11
Every access event is HMAC-signed and appended to an immutable audit ledger.
IEC 62304 Traceability
CI/CD evidence logs are cryptographically linked to regulatory clause IDs.
FDA eSTAR Ready
Auto-generate submission-ready Software Documentation Attachments on demand.
Zero-Trust Architecture
JWT + HMAC double-lock on every ingest endpoint. No anonymous writes.
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