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ISPE releases data integrity guidance

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Guide integrates cultural excellence, critical thinking skills into data integrity practices

The International society of pharamaceutical Engineering (ISPE),announced the release of their latest Guide, ISPE GAMP RDI Good Practice Guide: Data Integrity. This publication provides detailed practical guidance to support data integrity within a regulated organization.

John Bournas, ISPE CEO and President said,”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.”
“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 and Critical Thinking

ISPE will showcase the newly released, ISPE GAMP RDI Good Practice Guide: Data Integrity at their 2018 Annual Meeting and Expo in Philadelphia in 2018.

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