ISPE Releases ISPE GAMP RDI Good Practice Guide: Data Integrity

05 June, 2019

GAMP RDI Good Practice Guide: Data Integrity - Key Concepts

ISPE announced the release of their latest guide, ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records. This guide features the expectations and requirements for data integrity and quality management in GMP facilities. Industry manufacturers can discover approaches and methods for eliminating the risk of data integrity violations.

“Data integrity guidance should be utilized to ensure a strong foundation in product quality and safety to meet the pharmaceutical industry’s top priority: improving the quality of life for patients,” said Lorrie Vuolo-Schuessler, Senior Director Computer Systems Quality and Data Integrity, Syneos Health, Guide co-lead. “The guide is a professionally reviewed advisory resource for pharmaceutical manufacturers and engineers to use in navigating the complex data that defines the global regulatory expectations for data integrity”.

From this guide, users will learn how to:

  • Interpret regulatory requirements and meet expectations based on industry best practices
  • Define the data integrity approach for planning project activities
  • Apply risk management to all aspects of the data lifecycle
  • Identify roles and responsibilities to manage the data within the data lifecycle
  • Develop an appropriate data strategy for manufacturing IT systems

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.

Purchase the new ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records online, among ISPE’s other detailed education resources on a variety of industry topics.

Buy Now