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FDA eSTAR · IEC 62304 · 21 CFR Part 11

Automated eSTAR Compliance for Modern MedTech.

Continuous CI/CD traceability and automated IEC 62304 document generation — so your engineering team ships features, not paperwork.

IEC 62304 Compliant21 CFR Part 11HMAC-Signed EvidenceFDA eSTAR Ready

How It Works

From commit to compliance, automatically.

01

Push Code

Every commit to main triggers the omnis-run CI/CD wrapper, capturing test execution in real time.

02

Automated Traceability

Evidence logs are HMAC-signed and linked to IEC 62304 clauses — no manual mapping required.

03

eSTAR Generation

Export a submission-ready FDA eSTAR Software Documentation Attachment as a compiled PDF.

Platform Preview

The Single Source of Compliance Truth.

Every CI/CD run, every regulatory clause, every digital signature — unified in one cryptographically-sealed ledger.

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Omnis RegOpsLive · IEC 62304 · 21 CFR Part 11

IEC 62304 Traceability Matrix

4 clauses
§5.1.1Software Development Planning
sig: a3f9c2…d841
Compliant
§5.3.2Software Architectural Design
sig: b7e10d…f229
Compliant
§5.5.1Software Unit Implementation
sig: c2d84a…9b03
Compliant
§5.7.4Regression & Integration Testing
sig: d91f3e…c571
Pending
Submission Readiness75.0%

CI/CD Activity Feed

Live

omnis-run: Verification Successful — Payload Signed

test_dicom_parser.py·2026-06-09T04:12:08Z

omnis-run: Verification Successful — Payload Signed

test_phi_anonymizer.py·2026-06-09T03:47:33Z

omnis-run: Anomaly Detected — AI Review Flagged

test_cgm_alerts.py·2026-06-09T03:11:55Z

omnis-run: Verification Successful — Payload Signed

test_soup_codecs.py·2026-06-09T02:58:17Z

omnis-run: Verification Successful — Payload Signed

test_s3_ecg_pipeline.py·2026-06-09T02:30:44Z
5 evidence logs · Last ingested 2 min agoView Compliance Matrix
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