ISPE GAMP Guide: Records and Data IntegrityThe ISPE GAMP® Guide: Records and Data Integrity provides you with principles and practical guidance on meeting current expectations for the management of GxP regulated records and data—ensuring that they are complete, consistent, secure, accurate, and available throughout their life cycle.

This guide addresses the integrity of GxP records and data used within the regulated life science industries including pharmaceutical, biological, and medical devices. The guidance is intended for regulated companies and suppliers of systems, products, or services in this area, as well as a providing a useful reference for regulators.

Key concepts that you can take away from this guide include:

  • Risk Management Approach
  • Data Governance
  • Data Life Cycle
  • Key Concepts Summarized by ALCOA and ALCOA+
  • GxP Computerized System Life Cycle

Structure of the ISPE GAMP® Guide: Records and Data Integrity:

  • Data integrity requirements, critical areas of regulatory focus and concern, and key concepts
  • Framework for data governance and the importance of human factors
  • Complete data life cycle approach as part of a Quality Management System (QSM), from creation to destruction
  • Further information on how to apply the Quality Risk Management (QRM) approach from ISPE GAMP® 5 to record and data integrity
  • More detailed information, including “how to” guidance for specific topics, in a series of Management, Development, and Operation appendices

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Thank You to All Guide Contributors:  
Chris Clark, TenTenTen Consulting, United Kingdom * Colin Jones, Conformity Limited, United Kingdom * Tony Margetts, Factorytalk Co., Ltd., Thailand * Mark Newton, Eli Lilly and Company, USA * Arthur “Randy” Perez, Novartis (retired), USA * Nigel Price, QCDI Ltd., United Kingdom * Chris Reid, Integrity Solutions Ltd., United Kingdom * Mike Rutherford, Eli Lilly and Company, USA * Lorrie Vuolo-Schuessler, GlaxoSmithKline, USA * Charlie Wakeham Waters Australia Pty. Ltd., Australia * Christopher White, Alexion Pharmaceuticals, USA * Guy Wingate, GlaxoSmithKline, United Kingdom * Sion Wyn, Conformity Limited, United Kingdom

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