The guide provides an overview of principles and practical guidance on meeting current expectations for the management of GxP regulated records and data
The International Society for Pharmaceutical Engineering (ISPE) has released their 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 addresses the integrity of GxP records and data used within the regulated life science industries including pharmaceutical, biological, and medical devices.
Key concepts from this guide include:
- Risk management approach
- Data governance
- Data life cycle
- Key concepts summarised by ALCOA and ALCOA+
- GxP Computerised System Life Cycle