The guidance has been revised to conform with GAMP® 5 concepts and terminology, as well as recent regulatory and industry developments. These revisions support ISPE’s overall mission to help the industry focus attention on patient safety, product quality and data integrity.
“As the industry continues to focus on solutions to quality issues, the industry’s reliance on laboratory computer systems becomes more widespread, and automated laboratory testing and data management operations continue to increase in sophistication and complexity,” said Christopher White, a member of the team creating this Guide. “At the same time, laboratory personnel typically lack expertise in implementing laboratory systems. This Guide helps them understand the process so they can be effective in this area.”
The ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) contains steps that scientists, suppliers and others involved in managing laboratory computerized system acquisition, implementation, and operations can use to verify laboratory computerized systems are fit for their intended use. The Guide provides a practical, risk-based approach, thus eliminating trial and error. Following the principles outlined in the Guide, companies can save time and money, improve communication with external parties and achieve higher quality, better performing systems.
The ISPE GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition) is available for purchase on the ISPE website.