GAMP® Good Practice Guide: A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems (Second Edition)

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Published: October 2012

Pages: 160
Table of Contents ( 215 KB)

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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.

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