#04-essential-documents

Essential Documents

Start-Up & Regulatory

A3Phase 1Idle

Human gate role

QA / Regulatory (A2 for completeness sign-off)

Purpose

Continuous classification, naming, filing, and completeness checking of regulatory / eTMF documents.

Regulatory Dossier

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

Not production-ready

#04-essential-documentsA3Start-Up & RegulatoryHigh risk

Human gate role

QA / Regulatory (A2 for completeness sign-off)

Model registry version

unpinned

SOP version

SOP-04-v1.1

Last validated

never validated

Unknown

Credibility evidence

Autonomy A3 — human-on-the-loop.
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

No validation runs recorded yet — golden dataset run required.
Model registry version is not pinned.

View full validation history →

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 2)

Entity	State	Created	Signature
document_classification 95ca4f9a-3e77-43ae-8d63-912791682c72	signed	99d ago	—
essential_document 18a44f37-c938-4fb8-8ad6-11410f1b4aa6	promoted	106d ago	—

Golden dataset coverage

Cluster

Start-Up & Regulatory

Autonomy

Golden cases

≥10 ✓

Coverage is enforced platform-wide by the Q7 CI gate. See evals/datasets/04-essential-documents/golden.yaml.