Jeffrey C. Mocny, PhD, of Abzena, and Anna McMahon, MS, of Cellares, discuss how biopharmaceutical risk-based standards accelerate innovation and speed-to-market by leveraging data for better patient outcomes and safety.
Quality and Regulations 2026 eBook
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.
As quality control labs move toward more connected, data-driven operations, digital technologies must be adopted in a way that upholds patient safety.
CMC teams can align with Q5A(R2)’s updated guidance to shorten testing timelines and strengthen assurance of participant safety.
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