AI in GxP

A Practical Guide to Global Rules, Validation and Governance

How to use AI in GxP work so that inspectors, quality units and management can rely on it: the global rulebook, one agreed path from use case to validated use, technical implementation, governance and area profiles.

By Reinhold Schilling

Artificial Intelligence
GxP
Validation
AI Governance
EU AI Act

Publication information: English
Publication information: 2026

First edition, November 2026. PDF, 241 pages; status of sources 26 October 2026. Contents, price and purchase options are on the books page.

Details and purchase

Target audience

For executives, quality and validation professionals, IT and data science teams, and project leads who have to make AI work under GxP inspection.

About this publication

AI reached GxP work before AI-specific guidance matured. Between 2024 and 2026 regulators produced a dense run of documents on the subject, from different authorities and with very different legal weight. This book sets out their common ground and turns it into decisions that can be taken in a real company, with real budgets and real inspections.