Blog · GxP practical knowledge
GxP, AI and validation — without the show.
The traqx blog explains how regulated teams can use AI without giving up traceability, data control or QA responsibility.
Using AI in GxP — without giving up control
Is AI allowed in GxP? Long answered — the question is how controlled. The practical guide: draft Annex 22, GAMP 5, FDA CSA and the five principles that keep every result evidenced.
EU GMP Annex 22: what the first AI annex means for your GxP practice
Static models, human oversight, independent test data, explainability: what the draft requires — and how to prepare today.
GAMP 5 2nd Edition: What CSV now needs
The Second Edition modernizes CSV: critical thinking, agile lifecycles, cloud and AI. What you need to adjust — and what not.
CSA vs CSV: What the FDA Final Guidance means for your validation strategy
Computer Software Assurance supersedes CSV: less documentation, more critical thinking. What the FDA guidance means for your strategy.
Make Computer System Validation more predictable: The pragmatic guide
Make CSV more predictable — clear phases, risk-based test depth and evidence that is not assembled only at the end.
Blog content is guidance, not legal or compliance advice.
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