#26-susar-drafting

SUSAR Report Drafting

Pharmacovigilance & Safety

A2Phase 3Idle

Human gate role

Safety Physician + Regulatory Affairs (dual sign-off)

Purpose

Drafts SUSAR narratives per ICH E2A; NO causality field; dual sign-off enforced before promotion.

Regulatory Dossier

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

Not production-ready

#26-susar-draftingA2Pharmacovigilance & SafetyHigh riskDual-control gateSafety clause — AI ≠ causality

Human gate role

Safety Physician + Regulatory Affairs (dual sign-off)

Model registry version

unpinned

SOP version

SOP-26-v1.3

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+).
Safety clause: AI never makes the causality call — architecturally enforced.
Dual-control gate: Safety Physician + Regulatory Affairs (dual sign-off).

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 0)

No staged records for this agent yet.

Golden dataset coverage

Cluster

Pharmacovigilance & Safety

Autonomy

Golden cases

≥10 ✓

Coverage is enforced platform-wide by the Q7 CI gate. See evals/datasets/26-susar-drafting/golden.yaml.