Thinking
One place for the writing, not a fragmented blog. The newsletter archive and long-form pieces on where CSV, CSA and AI in GxP are heading, plus the frameworks and the book. Read inside the quality and IT compliance functions of global pharma.
The flagship essays
“Validation, not AI”: what the pushback gets right
How to choose an AI validation partner in pharma
Books and guidance on validating AI in GxP: a reading list
ELSA is coming. Is industry ready? Part 3: how to prepare
ELSA is coming. Is industry ready? Part 2: what it hits
ELSA is coming. Is industry ready? Part 1: what changes
What the Annex 22 (AI) draft really asks of you
Why most pharma transformations stall, and how to be in the few that do not
AI will not remove documentation from validation. It will remove uncertainty.
The newsletter
Monthly insight on AI governance, digital quality, and the future of pharma compliance. Read by 9,000+ pharma professionals across LinkedIn and Substack. No filler.
Essays and editions
Digital Transformation in Pharma, Part 2: From Strategy to Real Implementation
Most transformations fail because the governance is absent, not the technology. What real implementation looks like.
Why 70% of Pharma Transformations Fail (and how to be in the 30%), Part 1
Root-cause analysis of transformation failures and the governance structures that separate the programmes that work.
AI Will Not Remove Documentation in Validation. It Will Remove Uncertainty.
Where AI genuinely changes the validation equation, and where human judgment stays irreplaceable.
The Future of Pharma Compliance: How Draft Annex 11 Will Transform CSV
Draft Annex 11 signals a shift in how regulators think about computerized systems. What it means for your strategy.
The Evolving Role of CSV Professionals
The CSV professional of 2020 and of 2026 are different roles. The skills that got you here won't get you there.
FDA's Refreshed Guidance on Electronic Systems in Clinical Trials
A CSV expert's reading of the updated guidance, with implications far beyond clinical.
The Need for Caution in Using AI for GxP Compliance
AI in GxP is not a silver bullet. Where caution is warranted and where enthusiasm is justified.
Transitioning from CSV to CSA: A Practical Guide
A step-by-step guide for organisations making the CSV to CSA transition under GAMP 5 Second Edition.
Revolutionise Your Validation Approach: CSV to CSA Masterclass
A strategic overview of risk-based thinking and modern validation approaches.
Critical Thinking in Data and Audit Trail Reviews
Why critical thinking matters more than checklists in data integrity and audit trail assessments.
Quality Management Systems 2.0, Part 2: Digitalization and Automation in Pharma 5.0
Implementation strategies for AI-assisted deviation management and CAPA automation.
Quality Management Systems 2.0, Part 1: The Operating Model
Defines the QMS 2.0 operating model and its application to deviation and CAPA workflows.
The Story of Misleading Job Descriptions
A candid look at how job descriptions in pharma IT quality often misrepresent the actual role.
Qualifying SaaS and IaaS: Creating Quality Agreements
Practical guidance on building quality agreements for cloud-hosted GxP systems.
Hyperautomation: How It Can Change CSV Forever
How RPA, AI and ML can reshape the validation lifecycle from end to end.
Automation vs Hyperautomation in CSV
Understanding the distinction between simple automation and hyperautomation in validation.
Validating AI in GxP: the practitioner's guide →
Out now. Read Chapter 3 free.
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