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Regulatory Calendar
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
—FDA Part 11 + EU GMP Annex 11
Regulatory exposure — commonly overlooked:
QA releases batch on AI recommendation without hash-chained record — batch recall insurance void.
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.
7 mandate layers (live)
Regulatory Clock
Countdown to operative regulatory deadline — NAIC adoption, GSE mandate, EU transposition.
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Domain Classifier
Industry-specific SAFE/CRISIS/VIOLATION with regulatory framework mapping.
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Exhibit / Filing Pack
Regulator-ready external validation — NAIC Exhibit D, Fannie QC, EU FRIA, FDA Part 11.
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Mandate Registry
Enroll deployers/insureds under vertical-specific governance mandate.
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Bind / Action Gate
ALLOW/BLOCK before consequential action — bind policy, sell loan, deactivate worker.
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Compliance Certificate
Deployer-facing downloadable cert — forward to counsel, auditor, regulator.
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Actuarial / Risk Feed
Anonymized asymmetry signals for pricing, reserving, reinsurance correlation.
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