Automate 21 CFR Part 11 Compliance Without Slowing Down Engineering.
The first zero-touch QA pipeline for MedTech. Map FDA requirements directly in your code, let AI triage discrepancies, and generate audit-ready traceability matrices instantly.
Core Platform
Three pillars. Zero compliance debt.
Every layer of the Qavro pipeline is purpose-built for FDA submission requirements — not retrofitted onto a generic CI tool.
Automated Ingestion
Map FDA requirements directly in your code. The omnis-run CLI binds test execution to regulatory clauses in real-time.
1 import pytest
2 from omnis_run import req
3
4 @pytest.mark.req("IEC-62304-5.1")
5 def test_dicom_parse():
6 assert parse_dicom(fixture) …
$ omnis-run . ── SIGNED
AWS Bedrock Triage
Stop manually reviewing false positives. Our AI agent automatically categorises test failures against your risk management files.
test_phi_anonymizer.py
IEC-62304-5.7
test_cgm_alerts.py
IEC-62304-5.5
test_s3_ecg_pipeline.py
IEC-62304-5.3
Append-Only Ledgers
Cryptographically-sealed evidence logs. Generate 21 CFR Part 11 compliant traceability matrices instantly.
sha: a3f9c2d8…4e1b
sha: c2d84a91…9b03
sha: d91f3e0c…c571
How It Works
From commit to compliance, automatically.
Push Code
Every commit to main triggers the omnis-run CI/CD wrapper, capturing test execution in real time.
Automated Traceability
Evidence logs are HMAC-signed and linked to IEC 62304 clauses — no manual mapping required.
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.
IEC 62304 · 21 CFR Part 11 — Evidence Log
5 clausesSoftware Development Planning
test_dev_plan_audit.py
Software Architectural Design
test_arch_design.py
Software Unit Implementation
test_dicom_parser.py
Regression & Integration Testing
test_cgm_alerts.py
Audit Trail — Time-Stamped Records
test_audit_trail.py
CI/CD Activity
Livetest_dicom_parser.py
2026-06-09T04:12:08Z
test_phi_anonymizer.py
2026-06-09T03:47:33Z
test_cgm_alerts.py
2026-06-09T03:11:55Z
test_soup_codecs.py
2026-06-09T02:58:17Z
test_s3_ecg_pipeline.py
2026-06-09T02:30:44Z
Under the Hood
Enterprise-Grade Architecture
Supabase RLS
Absolute data isolation.
Strict Row-Level Security policies enforced at the Postgres level. Multi-tenant architecture guarantees that cross-contamination of regulatory evidence is cryptographically impossible.
AES-256 Encryption
Tamper-proof audit logs.
All Part 11 audit trails are hashed and encrypted at rest. Evidence ledgers are append-only, preventing post-execution mutation by any user or automated process.
Deterministic CLI
Zero silent failures.
The omnis-run binary is compiled under strict IEC 62304 bounds. Network drops or parsing errors trigger explicit aborts to guarantee pipeline integrity.
Ready to automate your
regulatory pipeline?
Get your workspace eSTAR-ready in less than five minutes.
No credit card required · IEC 62304 compliant from day one