Transparent scope, transparent price. Each engagement is designed to reduce inspection risk and get AI into validated GMP use faster.
A 3–5 day remote review of one system or your AI portfolio, with your top-5 risks and a working call. Credited toward a full audit.
A 2–4 week assessment against FDA CSA, GAMP 5 & the GAMP AI Guide, 21 CFR Part 11, EU Annex 11/22, and ALCOA++. Deliverables: audit report, risk register, and a prioritized remediation roadmap.
We author and execute the fixes — validation plans, Part 11 and data-integrity controls, AI model documentation, SOPs — to bring systems into validated, inspection-ready state.
A verification layer that plugs into your existing QMS: system inventory, protocol library, evidence dossier, and periodic re-verification — so your AI/data systems stay audit-ready between inspections.
Quality, CMC/regulatory, and manufacturing leaders — and founders at pre-commercial companies — adopting AI/ML or modernizing data systems in GxP operations.
