Published: February 2008
Pages: 356
- Table of Contents
- Table of Contents Supporting Materials
- Special Pricing for Emerging Economies
Ten years after its publication, the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems is regarded as the definitive industry guidance on GxP computerized system compliance and validation for companies and suppliers and is referenced by regulators worldwide. Read the article written by Sion Wyn, member of the GAMP® Community of Practice, about the relevancy of the Guide and where the GAMP® community should focus its efforts in the future.
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.
Valuable supporting materials, including key diagrams, templates, forms, example documents, and background information is available to download for purchasers of GAMP® 5. A Zip file with these supporting materials will be provided to purchasers through the ISPE Bookstore. A detailed list of contents is included in the downloadable Zip file.
To get more information about this Guidance Document, please visit the ISPE global site or contact ISPE Shanghai by email at askispeshanghai@ispe.org.
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