Insights
Practical writing on computer system validation (CSV), data integrity and regulatory change in pharma and life sciences, from a working validation consultant.
What you will find here
- Practical articles on how to do validation work in a risk-based way, in plain English.
- Regulatory updates that explain what a new guidance document or warning letter means for your systems.
- Grounded in official sources, written from practice. Articles are based on regulators' own publications, such as FDA, EMA, MHRA and PIC/S documents, and explained with the benefit of real industry experience.
Members read each new article first. Articles appear here after members have had them for a while.
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