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

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

English

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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.)

German

GAMP 5 German Cover Image

GAMP 5: Ein risikobasierter Ansatz für konforme GxP-computergestützte Systeme

Inhaltsverzeichnis ( 538 KB)

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French

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GAMP 5: Une approche de la conformité des systèmes informatisés BPx basée sur les risques

Table des matières ( 467 KB)

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Chinese

Are you a native Chinese speaker and worried about whether or not you can fully understand the English version of GAMP 5? Are you worried about having a contrast between the GAMP 5 English versus Chinese?

The Chinese GAMP 5 was reviewed several rounds by pharmaceutical industry experts. The dedicated review team went through a long review process and leveraged lots of their rich experience while doing the review and translation. You are sure to have a better understanding of GAMP 5 after reading this technical document.

Please contact China@ispe.org for more details and to order this industry guide.

Last Update: 13 February 2014
Date of Last Technical Review: 12 December 2010

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