healthcare · FDA 21 CFR Part 11 · GCP ICH E6 · EU AI Act Annex III
Pharma / Clinical Trials
21 CFR Part 11 already requires what Velaru does — not AI safety, compliance
—EU AI Act Annex III — healthcare/life sciences
Regulatory exposure — commonly overlooked:
Sponsors using vendor AI for protocol deviation detection — sponsor owns FDA finding, vendor owns nothing. · Federal agencies disagree on AI approach — but examiners agree internal logs are insufficient.
TAM / Exposure
$200B+ pharma R&D · AI in trial design exploding
Insurance lines
Product liability · Clinical trial E&O
Exhibit authority
US Federal Exhibit — 21 CFR Part 11 Clinical AI Audit Pack
Global leaders
FDA · Pfizer · IQVIA · Veeva · EMA · NAIC · FTC · EEOC
483 observations
FDA inspection: show audit trail for AI-flagged deviation — altered records = criminal referral pattern.
ICH E6 GCP
AI-assisted monitoring must be in validation documentation — post-hoc PowerPoint fails.
Trial insurance
Clinical trial insurers now ask AI governance questionnaire — receipts beat questionnaires.
[United States (Federal)] Agency pincer
FTC, CFPB, EEOC, and DOJ all active on AI — one receipt chain satisfies cross-agency discovery.
[United States (Federal)] Federal preemption fight
State laws filling void — multistate operators need jurisdiction-tagged receipts.
[Text / Chat] Modality hook
Baseline — all frameworks apply to text decisions.
7 mandate layers (live)
Regulatory ClockCountdown to operative regulatory deadline — NAIC adoption, GSE mandate, EU transposition.Open →
Domain ClassifierIndustry-specific SAFE/CRISIS/VIOLATION with regulatory framework mapping.Open →
Exhibit / Filing PackRegulator-ready external validation — NAIC Exhibit D, Fannie QC, EU FRIA, FDA Part 11.Open →
Mandate RegistryEnroll deployers/insureds under vertical-specific governance mandate.Open →