Foundation — runs under every stage
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
Start here
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Draft, What Inspectors CiteA regulator-sourced map of every rule touching AI in GxP today, separating binding text from draft guidance with inspection evidence.
- EU GMP Annex 22: What the AI Annex Actually SaysThe July 2025 draft bans generative AI from critical GMP applications. Here is exactly what it permits, and what changes.
In depth
8 articles
Specific problems, specific answers, each written against a named source and dated.
- 01How to Validate a Non-Deterministic LLM Without Pretending It Is DeterministicBounded nondeterminism, guardrail qualification, abstention thresholds and revalidation triggers, a complete test strategy for generative systems inside regulated pharmaceutical processes.
- 02Your Validated Model Has a Retirement DateCloud platforms silently upgrade model deployments unless disabled, turning one deployment property into a genuine change-control obligation for validated systems.
- 03Human Oversight Is a Control You Qualify, Not a Sentence in Your Risk AssessmentReduced model testing is bought with monitored operator performance; most oversight designs never budget for that second expensive operating obligation.
- 04Computer Software Assurance Is Device Guidance — Cite It for a Drug System and FailFDA reissued Computer Software Assurance in February 2026 for medical devices only; here is what drug sponsors must cite instead.
- 05EU GMP Annex 22, Clause by ClauseEvery numbered requirement in the draft artificial intelligence annex, translated into the exact evidence a GMP inspector will actually demand.
- 06Nineteen Pages, Seventeen Chapters: The Annex 11 Revision Clauses That Cost MoneyA line-by-line reading of the revised computerised systems annex, flagging every new obligation that carries a real budget consequence today.
- 07Nine Contract Clauses Your AI Vendor Will Refuse to SignWhat a GxP quality agreement must contain for an AI or SaaS supplier, and which model providers refuse outright today.
- 08Drift, Abstention and Audit Trails: The Operating Plan a Deployed GxP Model NeedsSix monitoring signals, the metrics behind each, and the change-control decisions determining when a deployed regulated model must be retested.