Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

ISPE Updates Guidance for GxP Compliant Laboratory Computerized Systems

ISPE, a leading authority on publishing best practices documents for the pharmaceutical industry, announced today that it has issued updated guidance for GxP compliant laboratory computerized systems.

This content was written and submitted by the supplier. It has only been modified to comply with this publication’s space and style.

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.

Medical Device Innovations Report
Cutting-edge packaging technologies are transforming the medical device sector in PMMI’s “Innovation in Medical Device” report, featuring advanced materials, smart solutions, and evolving regulations. Editors share insights from nearly 300 PACK EXPO booth visits—each product deemed new and truly innovative—alongside video demonstrations of the equipment and materials on display.
Learn More
Medical Device Innovations Report
Researched List: Blister Machines for Life Sciences
Need a blister machine for life sciences packaging? Our curated list features companies serving pharmaceutical, medical device, nutraceutical, and cosmetic industries. Download to access company names, locations, machine specifications, descriptions, and more.
Download Now
Researched List: Blister Machines for Life Sciences