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. · Multinationals built for one jurisdiction fail exams in another — one receipt architecture, many filing packs.
TAM / Exposure
$200B+ pharma R&D · AI in trial design exploding
Insurance lines
Product liability · Clinical trial E&O
Exhibit authority
Global External Validation — 21 CFR Part 11 Clinical AI Audit Pack
Global leaders
FDA · Pfizer · IQVIA · Veeva · EMA · ISO · NIST · OECD
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.