#15-coding

Medical Coding (MedDRA / WHODrug)

Data Management

A2Phase 2Idle

Human gate role

Medical / data review

Purpose

Codes adverse events and medications to MedDRA/WHODrug with confidence scoring; low confidence escalates.

Regulatory Dossier

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

Not production-ready

#15-codingA2Data ManagementHigh risk

Human gate role

Medical / data review

Model registry version

unpinned

SOP version

SOP-15-v1.2

Last validated

never validated

Unknown

Credibility 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

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 1)

Entity	State	Created	Signature
ae_coding 3347c19d-1bde-4a5f-98b3-6f2424aeba92	signed	99d ago	—

Golden dataset coverage

Cluster

Data Management

Autonomy

Golden cases

≥10 ✓

Coverage is enforced platform-wide by the Q7 CI gate. See evals/datasets/15-coding/golden.yaml.