I help pharma, biotech, medical device and CDMO organisations put AI into regulated quality and modernise validation, without trading away the inspection. The work behind this practice has run at enterprise scale and through Health Authority inspection with zero observations.
I have spent a career leading quality IT and digitalisation at scale across global pharmaceutical and consumer-health organisations. That meant enterprise quality systems used by around fifteen thousand people, paperless validation rolled out across more than forty sites, large cloud migrations, and quality digitalisation programmes measured in tens of millions. The common thread was making digital quality faster and cleaner while keeping it inspection-ready.
I have put AI into live GxP quality, three deployed tools across deviations, queries and CAPA support, and taken that work through a Health Authority inspection with zero digital compliance observations. Very few people can say they have done that. It is the hardest problem most of my clients have, and it is the one I know from the inside.
I sit on the regulator side of the same questions clients bring me. I contributed to the industry review of the EU GMP Annex 22 (AI) draft, sit on the Global GAMP Steering Committee, served as Chair of the GAMP India Steering Committee and Director of ISPE India, and have taken part in multiple industry standard reviews. Alongside the committee work, I have spoken at more than 70 global forums and written more than 25 industry whitepapers. The governance I help build is shaped by where the rules are actually heading, not by guesswork about them.
I am independent and senior-led. You get my judgment on your programme, not a pyramid of juniors learning on your time. When a programme needs hands, I bring vetted delivery partners and stay product-neutral, so the advice is always about your risk. The named approaches I use, DRIVE, QMS 2.0 and the AI Governance Stack, are all things I have deployed, not theory.
The book, Validating AI in GxP: A Practitioner's Guide, is where I have written the whole of it down.