GAMP Records and Data Integrity Encourages Innovation
ISPE announced the release of our latest guidance document ISPE GAMP® Guide: Records and Data Integrity. This guide provides an overview of principles and practical guidance on meeting current expectations for the management of GxP regulated records and data—ensuring they are complete, consistent, secure, accurate, and available throughout their life cycle.
“This new guide describes the data life cycle, and was intended to be used along with GAMP 5, which describes the system life cycle,” said Mark Newton Associate Senior Quality Assurance Consultant, Eli Lilly and Company. “Together, they provide a comprehensive overview of concepts necessary to create data with integrity and quality. The elucidation of the data life cycle, a maturity model, and the great appendices make this guide different from other data integrity publications to date.”
The ISPE GAMP Guide: Records and Data Integrity was developed by the GAMP Community of Practice (CoP) of ISPE; a world-wide community of practitioners and subject matter experts who have been developing internationally accepted guidance on risk-based approaches to safeguard patient safety, product quality, and data integrity for over twenty-five years.
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