GxP, validation & assurance
GAMP 5, Annex 11, draft Annex 22, Part 11, CSA, data integrity and AI governance — how you prove to an inspector that a system nobody can fully predict is under control.
- Computer system validation
- Computer software assurance
- Data integrity & ALCOA++
- AI governance & the EU AI Act
- Audit & inspection readiness
The guides
The long, definitive pieces on gxp, validation & assurance. Everything else on this page goes deeper on one part of them.
Validating AI Under GxP in 2026: What Binds You, What Is Draft, What Inspectors Cite
A regulator-sourced map of every rule touching AI in GxP today, separating binding text from draft guidance with inspection evidence.
GxP, validation & assurance · 18 min readEU GMP Annex 22: What the AI Annex Actually Says
The July 2025 draft bans generative AI from critical GMP applications. Here is exactly what it permits, and what changes.
GxP, validation & assurance · 11 min read8 articles
Specific problems, specific answers, each written against a named source and dated.
How to Validate a Non-Deterministic LLM Without Pretending It Is Deterministic
Bounded nondeterminism, guardrail qualification, abstention thresholds and revalidation triggers, a complete test strategy for generative systems inside regulated pharmaceutical processes.
GxP, validation & assurance · 17 min readYour Validated Model Has a Retirement Date
Cloud platforms silently upgrade model deployments unless disabled, turning one deployment property into a genuine change-control obligation for validated systems.
GxP, validation & assurance · 11 min readHuman Oversight Is a Control You Qualify, Not a Sentence in Your Risk Assessment
Reduced model testing is bought with monitored operator performance; most oversight designs never budget for that second expensive operating obligation.
GxP, validation & assurance · 11 min readComputer Software Assurance Is Device Guidance — Cite It for a Drug System and Fail
FDA reissued Computer Software Assurance in February 2026 for medical devices only; here is what drug sponsors must cite instead.
GxP, validation & assurance · 11 min readEU GMP Annex 22, Clause by Clause
Every numbered requirement in the draft artificial intelligence annex, translated into the exact evidence a GMP inspector will actually demand.
GxP, validation & assurance · 16 min readNineteen Pages, Seventeen Chapters: The Annex 11 Revision Clauses That Cost Money
A line-by-line reading of the revised computerised systems annex, flagging every new obligation that carries a real budget consequence today.
GxP, validation & assurance · 13 min readNine Contract Clauses Your AI Vendor Will Refuse to Sign
What a GxP quality agreement must contain for an AI or SaaS supplier, and which model providers refuse outright today.
GxP, validation & assurance · 10 min readDrift, Abstention and Audit Trails: The Operating Plan a Deployed GxP Model Needs
Six monitoring signals, the metrics behind each, and the change-control decisions determining when a deployed regulated model must be retested.
GxP, validation & assurance · 15 min read