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.
The Practitioner Handbook · Sachin Bhandari
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The Practitioner Handbook · Sachin Bhandari · PDF edition
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The gap between "we use AI" and "we can defend it in an inspection" comes down to three things: how the risk was classified, whether the governance holds under scrutiny, and how well the evidence was built. This book works through each in sequence, from the first board conversation to the post-deployment monitoring plan.
Plus 15 appendices: 46 templates, SOPs, QRGs, an inspection question bank, a vendor-assessment framework, an Annex 22 evidence pack, and worked examples throughout.