AI is entering GMP manufacturing, QC, and the lab faster than quality teams can validate it — and in 2025 both the FDA and the EU issued new rules for exactly this. Locutum runs fixed-fee audits that tell you, in weeks, whether your systems would survive an inspection — and exactly what to fix.
Most quality consultants don’t speak AI. Most AI engineers don’t speak GMP. That gap — where machine-learning models and modern data pipelines meet regulated manufacturing — is exactly where inspections get uncomfortable. Locutum lives in that gap.
FDA finalized Computer Software Assurance (2025). ISPE released the first GAMP guide for AI. The EU published Annex 22 — its first GMP rules for artificial intelligence.
Data integrity is still the leading enforcement theme. Unvalidated AI and data systems are the newest — and least understood — exposure in an audit.
A defined-scope audit maps your AI/data systems to current expectations and hands you a prioritized, defensible remediation plan.
A clear, low-risk path from “are we exposed?” to “we’re inspection-ready.”
Start with a fixed-fee audit — or a low-cost readiness snapshot.
Book an audit