#27-audit-trail
Continuous Audit-Trail
Quality Assurance & Compliance
A2Phase 1Idle
Regulatory Dossier
Identity, controls, risk, and credibility evidence — the page an FDA inspector reviews first.
#27-audit-trailA2Quality Assurance & ComplianceHigh risk
Human gate role
QA Lead (A2 for findings)
Model registry version
claude-sonnet-4-6
SOP version
SOP-27-v1.1
Last validated
validated 14 weeks ago
StaleCredibility evidence
- Autonomy A2 — supervised agentic with human review + sign gate.
- Agents write only to staging; promotion to live requires a Part 11 e-signature.
- Every regulated action carries created_by, created_at, and provenance_id (ALCOA+).
References
Production readiness blockers
- Validation evidence is stale — re-run within the next 14 days.
Headline metrics (last 7 days)
Runs (24h)
—
Runs (7d)
—
Model-invoked (7d)
—
Signed (7d)
—
Last run
never
No runs recorded in the last 7 days for this agent.
Recent runs (last 0)
No provenance events recorded for this agent yet.
Recent staged records (last 3)
| Entity | State | Created | Signature |
|---|---|---|---|
| audit-trail-report f4b921d1-dd69-4a66-ae4e-3c797504bf82 | proposed | 95d ago | — |
| audit-trail-report bbcee6bc-d2e1-4999-9e09-0fd4869f511a | proposed | 95d ago | — |
| audit_trail_report c61c44b5-2851-4b85-9fa2-42f13d831e28 | reviewing | 99d ago | — |
Golden dataset coverage
Cluster
Quality Assurance & Compliance
Autonomy
A2
Golden cases
≥10 ✓
Coverage is enforced platform-wide by the Q7 CI gate. See evals/datasets/27-audit-trail/golden.yaml.