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Insights
Practical notes on Computer Software Assurance, data integrity and AI in regulated work.
These notes are written for the QA, IT and validation people who do the work. Each one takes a specific problem we see in practice and explains how we'd approach it, what regulators and industry guidance expect, and where teams usually go wrong. You won't find hype or vendor pitches here, just reasoning you can use and defend.
Your First CSA Program: What to Build First
If you're starting from nothing, this is the order that matters: program charter, policy, system inventory, risk method, SOPs, then IQ/OQ/PQ templates. It also explains why starting with templates usually backfires.
When Does an AI Tool Become a GxP Computerized System?
A practical test based on intended use and what the AI influences, using the GAMP 5 Appendix D11 framing.
Audit Trail Review That Actually Finds Things
Risk-based audit trail review: what to look at, how often, and how to document it without generating noise.
ALCOA+ in Hybrid and SaaS Environments
Where data integrity weaknesses tend to hide when records move between paper, on-premise systems and cloud applications.
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