← Mandate Registry · 7 mandate layers · gxp

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

—UAE AI Charter + ADGM AI guidance

Regulatory exposure — commonly overlooked:
QA releases batch on AI recommendation without hash-chained record — batch recall insurance void. · G42 and sovereign AI push — UAE wants auditable AI for government AND finance simultaneously.

TAM / Exposure

Every GMP facility globally · Part 11 is law today

Insurance lines

Product recall · Pharma E&O

Exhibit authority

UAE AI Charter Pack — GxP Electronic Records Integrity Pack

Global leaders

FDA · Merck · Lonza · Waters Corporation · ISPE · G42 · ADGM · Emirates NBD

Deviation reports

AI flags GMP deviation — without receipt, QA cannot prove when they knew.

Annex 11 EU

European GMP requires same integrity — global pharma needs one primitive.

Recall insurance

Insurers deny recall claims when electronic records integrity violated.

[UAE] Sovereign wealth

ADIA, Mubadala portfolio companies deploying AI — governance at scale.

[UAE] Cross-border hub

DIFC/ADGM English law + AI — receipt compatible with common law discovery.

[Text / Chat] Modality hook

Baseline — all frameworks apply to text decisions.

7 mandate layers (live)

Regulatory Clock Countdown to operative regulatory deadline — NAIC adoption, GSE mandate, EU transposition. Open →

Domain Classifier Industry-specific SAFE/CRISIS/VIOLATION with regulatory framework mapping. Open →

Exhibit / Filing Pack Regulator-ready external validation — NAIC Exhibit D, Fannie QC, EU FRIA, FDA Part 11. Open →

Mandate Registry Enroll deployers/insureds under vertical-specific governance mandate. Open →

Bind / Action Gate ALLOW/BLOCK before consequential action — bind policy, sell loan, deactivate worker. Open →

Compliance Certificate Deployer-facing downloadable cert — forward to counsel, auditor, regulator. Open →

Actuarial / Risk Feed Anonymized asymmetry signals for pricing, reserving, reinsurance correlation. Open →

Run gxp demo Regulatory calendar Download exhibit pack Verify independently