ISPE announced the release of 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
