GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems

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Guidance Documents

Published: February 2008
Pages: 356
Table of Contents ( Adobe PDF 245 KB)
List of material on the included CD ( 29 KB)

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Formats	Member Price	Nonmember Price
Bound Version	$250 / €195	$515 / €430
Individual Download	$250 / €195	$515 / €430
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GAMP^® 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500.

This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.

An exciting new innovation is the CD accompanying the Guide. It provides supporting materials, including differences between GAMP^® 4 and GAMP^® 5, key diagrams, templates, forms, example documents, and background information. (CD is Windows compatible only.)