Healthcare-specific profile of the AI Incident Card. Maps severity/type fields onto FDA MedWatch (21 CFR §803), EU MDR vigilance (Articles 87–89), IMDRF AE Terminology, and a CTCAE-aligned 5-grade clinical severity scale. Healthcare-readiness scaffolding, not certification.

Python + Streamlit pipeline simulating a pharma sterile facility's full EM adverse event workflow - auto-flags 39 exceedances across 5 ISO-classified cleanrooms, initiates investigation logs, detects repeat adverse events within 30-day windows, and exports cGMP-aligned audit-ready Excel reports.