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.
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.
Most transformations fail because the governance is absent, not the technology. What real implementation looks like.
Root-cause analysis of transformation failures and the governance structures that separate the programmes that work.
Where AI genuinely changes the validation equation, and where human judgment stays irreplaceable.
Draft Annex 11 signals a shift in how regulators think about computerized systems. What it means for your strategy.
The CSV professional of 2020 and of 2026 are different roles. The skills that got you here won't get you there.
A CSV expert's reading of the updated guidance, with implications far beyond clinical.
AI in GxP is not a silver bullet. Where caution is warranted and where enthusiasm is justified.
A step-by-step guide for organisations making the CSV to CSA transition under GAMP 5 Second Edition.
A strategic overview of risk-based thinking and modern validation approaches.
Why critical thinking matters more than checklists in data integrity and audit trail assessments.
Implementation strategies for AI-assisted deviation management and CAPA automation.
Defines the QMS 2.0 operating model and its application to deviation and CAPA workflows.
A candid look at how job descriptions in pharma IT quality often misrepresent the actual role.
Practical guidance on building quality agreements for cloud-hosted GxP systems.
How RPA, AI and ML can reshape the validation lifecycle from end to end.
Understanding the distinction between simple automation and hyperautomation in validation.
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