Publications and talks
This is my full public record on AI validation, CSV, CSA and digital quality. You'll find the book, my articles in trade journals, the newsletter, whitepapers and the talks I've given. Each list runs newest first, with the date and a link where one exists.
The book · Articles · Essays on this site · Newsletter · Whitepapers · Talks and webinars · Interviews
The book
Validating AI in GxP: A Practitioner's Guide
My practitioner's handbook on validating AI in regulated quality, with the templates and the inspection questions to expect. The digital PDF is sold on this site.
The print edition is on Amazon as Validating Artificial Intelligence Frameworks in GxP Environments: A Practitioner's Handbook.
Articles in trade publications
I wrote these pieces for industry publishers. Their editors worked on each one before it ran under my name.
Decision Integrity: The Layer ALCOA+ Was Never Built to Cover
When AI helps make a GxP decision, you need a record of how the decision was reached as well as the data behind it. This piece sets out how to govern the decision itself.
CSV Assumes the AI System Sits Still. It Doesn't.
A validated model can be retrained twice while the signed plan stays the same. This article explains why AI needs ongoing governance after go-live.
It also ran on Bioprocess Online, Cell & Gene, Outsourced Pharma, Med Device Online and Biosimilar Development.
The tier decision: four-tier risk classification for AI in GxP
I submitted this to ISPE's iSpeak blog in July 2026. The GAMP Editorial Review Board is reviewing it now, and I'll add the link here the day it's published.
Essays on this 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.
The Digital Compliance newsletter
I've written this newsletter since 2023, on LinkedIn and now also on Substack. The ELSA series and the essays above ran there too.
How AI reaches a validated site
The first 4 lessons of my 100-lesson series on validating AI in GxP, with the stories behind each one.
QMS 2.0: building a digital quality system that actually works
How to move quality management off paper and onto connected data, and where the integration gets hard.
You have audit trails. Do you have audit trail thinking?
Why a complete audit trail and a followed review procedure can still end in an inspection finding.
CSA isn't a shortcut. It's a demand for better thinking.
A practical guide to the CSV to CSA transition: what changes, what stays the same, and the governance that holds it together.
ALCOA+ Meets AI: The Single Biggest Challenge Pharma Has Never Faced Before
The gap between data integrity rules and AI systems, and why closing it is a governance job.
When the regulator reads everything.
What it means for you now that FDA can read a whole submission with its own AI tools.
Digital Transformation in the Pharmaceutical Industry, Part 2: From Strategy to Real Implementation
How to turn a digital quality strategy into platforms, validation and change that actually land.
Why 70% of Pharma Transformations Fail (And How to Be in the 30%), Part 1
The forces that quietly stall pharma transformation programmes, and a test for whether yours will work.
AI will not remove documentation in validation. It will remove uncertainty.
Why documentation stays in validation, and how AI can reduce the uncertainty behind it.
FDA's Refreshed Guidance on Electronic Systems in Clinical Trials: A CSV Expert's Perspective
What the updated FDA guidance on electronic systems in clinical trials asks of validation teams.
The Need for Caution in Using AI for GxP Compliance
Where AI helps GxP compliance, and where it needs a careful human check before you rely on it.
Transitioning from Computer System Validation to Computer Software Assurance: A Practical Guide
A 10-step roadmap for moving from document-heavy CSV to risk-based CSA.
Critical Thinking: The Cornerstone of Effective Data and Audit Trail Reviews in Pharma IT Quality
How to bring critical thinking to your data and audit trail reviews.
Quality Management Systems 2.0: Embracing Digitalization and Automation in Pharma 5.0, Part 2
The second half of the QMS 2.0 series, on putting a digital quality system into practice.
Quality Management Systems 2.0: Embracing Digitalization and Automation in Pharma 5.0, Part 1
The case for a digital, automated quality management system, written alongside my ICSVC talk.
Qualifying SaaS, IaaS: Creating Quality Agreements
What a GxP quality agreement with a SaaS or IaaS provider needs to cover.
Hyper Automation: How it can change the CSV forever
A closer look at where hyperautomation can cut the time and cost of CSV.
Automation Vs HyperAutomation in CSV
The difference between automation and hyperautomation, and what each one means for validation work.
Getting Data Smart
An early piece on moving from paper records to data you can actually use.
Whitepapers and industry guidance
I've written 25+ whitepapers over my career. These are the ones you can read in public.
Computer Software Assurance (CSA): ISPE GAMP India SIG whitepaper
I co-wrote this whitepaper on applying CSA in practice, and it came out before FDA published its CSA draft guidance.
The named frameworks
DRIVE, the AI Governance Stack, QMS 2.0, Enterprise Paperless Validation and Modular Qualification Architecture, written up in full on this site.
Talks and webinars
I've spoken at 70+ global forums. These are the talks with a public record online.
Governing, classifying and validating AI systems
A session with Martin King on keeping AI decisions explainable and ready for inspection.
Assessing AI Readiness: Prerequisites for Compliant Adoption Under FDA CSA
How to tell whether a site's data, systems and governance are ready for GxP AI, in line with FDA CSA and draft Annex 22.
The Hybrid Record Trap: Resolving the Conflict Between Paper and Databases
Why regulators treat the electronic database as the master GxP record, and how to reconcile it with printed summaries.
AI in Pharma
A 2-hour orientation on where AI touches the pharma value chain and how it behaves inside GxP, with a prompting method you can use at work.
The CSV-to-CSA roadmap: Modernising GxP validation
A 4-phase roadmap from legacy CSV to risk-based CSA, with steps a team can start on straight away.
Transforming Healthcare with AI: A Technical Roadmap to Innovation, Compliance, and Metrics
A panel on bringing AI into pharma and MedTech under validation, the EU AI Act and FDA expectations.
Unleashing the Power of AI: Practical Applications in Computer System Compliance
A panel on AI use cases in CSV and CSA, from harmonisation to qualification and maintenance.
Quality Management Systems 2.0: Embracing Digitalization and Automation in Pharma 5.0
How digital and automated quality systems meet the changing demands on pharma quality.
How to Modernize Risk Assessments with Critical Thinking
Moving CSV risk assessment beyond templates, plus a session on harmonising equipment qualification and a panel on CSA and generative AI.
Risk Assessment and Test Management for CSA
How to size testing to risk under GAMP 5 and FDA CSA.
Creating quality agreements with SaaS and IaaS providers
The GxP and CSV points a quality agreement with a cloud provider has to cover.
Interviews and features
Driving adoption of the paperless lab in India
A preview of my Paperless Lab Academy India talk on moving labs off paper.
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