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29th October 2018  Content supplied by: International Society for Pharmaceutical Engineering (ISPE)

ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts

The International Society for Pharmaceutical Engineering (ISPE) have released their latest Guide, ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts. This publication provides detailed practical guidance to support data integrity within a regulated organization.

"In recent years pharmaceutical, biotechnology, and medical device industries have experienced significant issues with data integrity worldwide, impacting the veracity and quality of the data on which a regulatory decision is based which ultimately affects patient safety," said John Bournas, ISPE CEO and President. "This Guide integrates Cultural Excellence and critical thinking skills into data integrity practices to aid companies in meeting regulatory requirements and expectations."

This Guide is positioned under the ISPE GAMP® Guide: Records and Data Integrity and is aligned with ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems. Detailed guidance is provided in four core areas

  • Data Governance
  • Data Lifecycle
  • Risk Management Approaches
  • Critical Thinking

ISPE will showcase the newly released, ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts at their 2018 Annual Meeting & Expo in Philadelphia on 4–7 November 2018. The new guide is also available online at www.ISPE.org/Publications/Guidance-Documents.   



Date Published: 29th October 2018

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