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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

—AIDA (pending) + OSFI E-23 model risk

Regulatory exposure — commonly overlooked:
QA releases batch on AI recommendation without hash-chained record — batch recall insurance void. · Quebec Law 25 already strict on automated decisions — ROC catching up with AIDA.

TAM / Exposure

Every GMP facility globally · Part 11 is law today

Insurance lines

Product recall · Pharma E&O

Exhibit authority

Canada OSFI E-23 Pack — GxP Electronic Records Integrity Pack

Global leaders

FDA · Merck · Lonza · Waters Corporation · ISPE · OSFI · RBC · OPC

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.

[Canada] OSFI banks

Canadian bank AI — E-23 model risk parallels SR 11-7.

[Canada] Bill C-27

AIDA when passed — early receipt infrastructure = compliance head start.

[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