Massive Data, More Decentralization Drive Updates to ISPE GAMP Guide
Frank Henrichmann, Co-Chair of the ISPE GAMP® Global Steering Committee and Coauthor of ISPE GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (Second Edition), discusses the updated ISPE Guide, which provides recommendations for risk-based systems validations related to Good Clinical Practice (GCP). The Guide has been updated to address the rapid progression towards digital transformation and covers new topics such as decentralized clinical trials, the evolution of data management into data science using AI solutions, and guidance for the generation of real-world evidence (RWE) from real-world data (RWD).
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View more on the ISPE Guide page.
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