New ISPE GAMP® Guide: Records and Data Integrity Encourages Innovation While Avoiding Risk to Product Quality, Patient Safety, and Public Health

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The ISPE Guide addresses the integrity of GxP records and data used within the regulated life science industries including pharmaceutical, biological, and medical devices.

ISPE GAMP® Guide: Records and Data Integrity
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 International Society for Pharmaceutical Engineering (ISPE) announced the release of their 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.

Find the newly released ISPE GAMP® Guide: Records and Data Integrity at http://www.ISPE.org/Publications-Guidance-Documents.

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.

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 life cycle. The more than 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 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: mrobertson(at)ispe(dot)org
http://www.ISPE.org

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Maria Robertson
ISPE
+1 813-960-2105 Ext: 404
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