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Cleaning validation scope expands quickly in multiproduct facilities.

A multiproduct facility may have dozens of products, multiple equipment trains, different cleaning procedures, and hundreds of possible produc...


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Does draft EU GMP Annex 22 mean generative AI (GenAI) has no place in GxP validation? The answer depends in large part on how and where AI is being used. 

Annex 22 is still evolving, and so is the broader regulatory con...


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Computerized system validation (CSV) practices continue to evolve as life sciences organizations look for more risk-based ways to establish that software is fit for its intended use. The goal is not simply to reduce testing...


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