출판물-가이드라인

A Risk-Based Approach to Compliant GxP Computerized Systems

2016-12-07 by ISPE Korea

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. 

글목록

관련글

A Risk-Based Approach to Testing of GxP Systems (Second Edition)

Controlled Temperature Chamber Mapping and Monitoring