What is Validating AI in GxP: A Practitioner's Guide about?

It is a practitioner handbook for putting AI and machine learning into regulated pharma quality and keeping it inspection-ready. Across 19 chapters and 15 appendices it covers the regulatory spine (Annex 11, Draft Annex 22, 21 CFR Part 11 and FDA CSA), how to classify and risk-tier AI use cases, how to build validation evidence that holds, and how to monitor a model after go-live.

Quality, validation and IT leaders in pharma, biotech, medical device and CDMO organisations. It assumes you already know CSV and GxP and begins where that training stops: what changes once a system can learn.

What format is the book and how is it delivered?

It is a digital PDF of 292 pages with 28 templates and 22 mapped frameworks. After purchase you receive a personalised, watermarked copy by a secure download link. A full sample chapter (Chapter 3) and the complete table of contents are free to read with no sign-up.

How much does the book cost?

The individual edition is priced by region: $89 in the United States and the rest of the world, €79 in Europe, and ₹3,999 in India and developing economies. Organisations can request a company-named edition with unlimited internal use through a short form for a tailored quote.

Can I read part of the book before buying?

Yes. A complete sample chapter on why AI breaks the traditional CSV playbook, and the full table of contents as a PDF, are both available free with no sign-up.

●Out now · 2026

AI is already making calls inside GxP systems.

Name: Validating AI in GxP: A Practitioner's Guide
Price: 89 USD
Availability: InStock
Author: Sachin Bhandari

The validation playbooks haven't caught up.

For three years I kept reaching for a reference that did not exist: one practitioner guide that takes AI and ML validation in regulated pharma from the strategy a board needs in 90 seconds down to something a quality lead can act on Monday morning. So I wrote it.

19 chapters28 templates292 pages22 frameworks mapped

Validating AI in GxP Environments: A Practitioner's Handbook by Sachin Bhandari

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Validating AI in GxP Environments

The Practitioner Handbook · Sachin Bhandari · PDF edition

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Look inside, free

Read it before you decide

No sign-up, nothing to pay. Read a complete sample chapter (Chapter 3, why AI breaks the traditional CSV playbook), skim the full contents below, or take the whole table of contents as a PDF.

Read the sample chapter → Download the contents PDF

What's inside

The real problems of validating AI in GxP, worked through end to end

A working handbook that assumes you already know CSV and GxP, and begins where that training stops: what changes once a system can learn, how to classify and govern it, how to build evidence that holds, and how to keep it valid long after go-live. 19 chapters and 15 appendices across 292 pages.

Part 1 · Chapters 1–3

Getting your bearings

AI in GxP: the concepts that matter for validation
The regulatory spine: Annex 11, Draft Annex 22, Part 11 and CSA
Why AI validation breaks traditional CSV

Part 2 · Chapters 4–6

Classify and govern

Classification and risk tiering
The AI governance operating model
The AI Validation Master Plan

Part 3 · Chapters 7–10

Build the evidence

Data governance for AI
Performance acceptance criteria
Test data and the three independences
IQ, OQ and PQ redefined for AI/ML

Part 4 · Chapters 11–14

Keep it valid over time

Ongoing monitoring and drift response
Explainability and confidence
Change control and retraining
AI risk management beyond the tier model

Part 5 · Chapters 15–19

Prove it and scale it

Inspection readiness
Generative AI in non-critical GxP use
Large Language Models in regulated environments
AI in practice: tools you can use today
Building the AI programme: the first 100 days

The toolkit · Appendices A–O

28 template skeletons (T01–T28) · 6 SOP skeletons · 11 quick reference guides · glossary · inspection question bank · common findings and how to avoid them · vendor assessment framework · a worked evidence pack with an Annex 22 crosswalk · QMS integration · SaMD and CDMO appendices. Built to be adapted to your own quality system.

Wondering where this book sits against GAMP 5, Annex 22 and the FDA guidance? The reading list on validating AI in GxP places them all in order.