(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a leading authority on best practices for the pharmaceutical industry,  has issued updated and expanded guidance to help pharmaceutical companies maximize testing efficiency of computerized and software-based systems that affect patient safety, product quality, and data integrity. The second edition of the GAMP testing guide for GxP systems has been revised to conform with GAMP 5 concepts and terminology and reflect ICH Q8, Q9, and Q10, quality by design, and process analytical technology principles. It has also been expanded to include information on cloud computing, automated testing, and nonlinear development.

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