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gamp 5 second edition pdf
Yes, GAMP 5 Second Edition is the updated version of the Good Automated Manufacturing Practice (GAMP) guidelines published by the International Society for Pharmaceutical Engineering (ISPE) in July 2022. It builds upon the original GAMP 5 (2008) framework, providing enhanced guidance on computerized systems validation and data integrity in the life sciences industry. The second edition addresses modern technologies, such as cloud computing, artificial intelligence, and agile software development, while reinforcing a risk-based approach to system lifecycle management. It is designed to help ensure regulatory compliance and patient safety in an evolving digital landscape.
Name: Jessie Green
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