An FDA warning letter to Purolea Cosmetics Lab shows that AI-assisted drafting can support documentation work only when the resulting document is subject to quality-system controls.
Svyatoslav Borshchenko
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CEO and co-founder, GxPilot.
Articles by Svyatoslav Borshchenko
FDA’s 2024-2025 guidances and policy signals, when read together, point to a digital-by-default oversight model built on structured data exchange, more routine remote engagement, and clearer expectations for lifecycle control of automated systems used in regulated decisions. This article translates those signals into practical steps for chemistry, manufacturing, and control, as well as quality management systems.
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