ISPE Releases ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts
NORTH BETHESDA, Md. (PRWEB) October 25, 2018 -- The International Society for Pharmaceutical Engineering (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
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 http://www.ISPE.org/Publications/Guidance-Documents.
About ISPE
The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in North Bethesda, Maryland USA, and an operations and training center in Tampa, Florida USA. Visit http://www.ISPE.org for more information.
For more information, contact:
Maria Robertson
Senior Director, Marketing Communications
International Society for Pharmaceutical Engineering (ISPE)
Tel: +1-301-364-9207
Email: [email protected]
http://www.ISPE.org
Maria Robertson, ISPE, http://www.ISPE.org, +1 +1-301-364-9207, [email protected]
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