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GAMP Records and Data Integrity Encourages Innovation

Guidance Document Callout

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 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 Summarized by ALCOA and ALCOA+
  • GxP Computerized System Life Cycle

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.

ISPE also offers in-depth knowledge on data integrity through events like the 2017 ISPE Data Integrity Workshop and the new two-day training course, A GAMP® Approach to Data Integrity, Electronic Records and Signatures, and Operation of GxP Computerized Systems. For a list of upcoming education opportunities, view the ISPE global events calendar.