healthcare · FDA 21 CFR Part 11 · FDA 21 CFR Part 211 GMP · ICH E6 GCP
GxP / FDA 21 CFR Part 11 Pharma
Delete audit trail before inspection = automatic consent decree pattern
—NYDFS AI guidance + Local Law 144 enforcement
Regulatory exposure — commonly overlooked:
QA releases batch on AI recommendation without hash-chained record — batch recall insurance void. · Local Law 144 requires annual bias audit — Velaru receipts are continuous audit, not annual snapshot.
TAM / Exposure
Every GMP facility globally · Part 11 is law today
Insurance lines
Product recall · Pharma E&O
Exhibit authority
New York AI Governance Pack — GxP Electronic Records Integrity Pack