Worked out in the open
Everything I publish on AI validation, CSV, CSA and digital quality lives here: the essays, the series, the industry placements, the monthly regulatory radar and the book. New pieces land the week they appear.
On the site
CSV to CSA: the first 90 days
A transition plan scoped to one quarter, and the trap that stalls most programmes.
What an inspector asks about your AI
Six things you will be asked to show, not describe, with what a thin answer sounds like.
What the Annex 22 (AI) draft really asks of you
Intended use, data and human oversight: what to build before the draft is final.
How to choose an AI validation consultant
The evaluation criteria that matter, and how the known firms compare.
Books and guidance on validating AI in GxP
A reading list of what actually exists, from regulatory guidance to the practitioner shelf.
Validation, not AI: what the pushback gets right
Where the scepticism about AI in validation is earned, and where it costs you.
AI will not remove documentation from validation
Where AI genuinely changes validation work, and where human judgement stays in charge.
Why most pharma transformations stall
The root causes that stall digital quality programmes, and the habits of the ones that land.
ELSA is coming. Is industry ready?
A three-part series on the FDA's ELSA and what agency-side AI means for the industry it inspects.
Off the site
The tier decision: four-tier risk classification for AI in GxP
Submitted to ISPE's iSpeak blog, July 2026. The link lands here the day it publishes.
Decision integrity · Why validating AI is a different ballgame
Long-form pieces published on LinkedIn, with the monthly Regulatory Radar on AI in GxP.
CSA Virtual Event 2026 · Scilife Quality Summit 2026
Sessions on CSA and AI readiness, August and September 2026, and a confirmed speaking slot at the Scilife Quality Summit.
Validating AI in GxP: A Practitioner's Guide
The method in full: 19 chapters, the templates, and the inspection questions to expect. Digital PDF on this site, print on Amazon and Notion Press. Rated 4.8 out of 5 by its first readers.
Get the book →Coming next
More industry placements are in the pipeline over the coming months, alongside the monthly cornerstone essays and the Regulatory Radar. The fastest way to hear about each one is the newsletter.
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