#27-audit-trail

Continuous Audit-Trail

Quality Assurance & Compliance

A2Phase 1Idle

Human gate role

QA Lead (A2 for findings)

Purpose

Monitors audit trails across every system for anomalies, access violations, integrity issues.

Regulatory Dossier

Identity, controls, risk, and credibility evidence — the page an FDA inspector reviews first.

Ready for production

#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 10 days ago

Current

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+).

Runs (24h)

—

Runs (7d)

—

Model-invoked (7d)

—

Signed (7d)

—

Last run

never

No runs recorded in the last 7 days for this agent.

No provenance events recorded for this agent yet.

No staged records for this agent yet.

Cluster

Quality Assurance & Compliance

Autonomy

Golden cases

≥10 ✓

Coverage is enforced platform-wide by the Q7 CI gate. See evals/datasets/27-audit-trail/golden.yaml.