NOTICE: We are performing maintenance on the ISPE Guidance Documents Portal on Tuesday 14 May. Current users can access their existing content, however, new purchases cannot be made. We apologize for any inconvenience this may cause.
NOTICE: We are performing maintenance on the ISPE Guidance Documents Portal on Tuesday 14 May. Current users can access their existing content, however, new purchases cannot be made. We apologize for any inconvenience this may cause.
Published: October 2012
Pages: 160
Recently updated to conform with GAMP® 5 concepts and terminology, as well as recent regulatory and industry developments, 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 systems are fit for their intended use. The Guide provides a practical, risk-based approach for evaluating these systems, thus eliminating trial and error. By 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.
ISPE members located in nations with emerging economies* are eligible for a 50% discount on publications from the regular member price. To receive the discount, members must be logged in with their ISPE member account. Contact Member Services at ask@ispe.org for more information or if you have questions about your membership status or this discount program. Discounts do not apply to Techstreet document downloads.
*Based on the World Bank's system for classifying national economies by GNI per capita. Includes low-income, lower middle-income, and upper middle-income economies. To learn more about the World Bank classification system, please click here. Currently includes the following nations, except where international sanctions apply: