GAMP 5 Guide: Compliant GxP Computerized Systems (Polish Translation)

GAMP 5 Guide: Compliant GxP Computerized Systems (Polish Translation) cover image

Title:

GAMP 5 Guide: Compliant GxP Computerized Systems (Polish Translation)

Author(s):

Bredesen, Anders; Brooks, Sam; Buffi, Jay; Cappucci, Winnie; Cherry, Mark; Clark, Chris; Evans, Gail; Hambloch, Heinrich; Jones, Colin; Kane, Paige; Margetts, Tony; Perez, Arthur "Randy"; Robertson, Peter; Samways, Kate; Selby, David; Wingate, Guy; Wyn, Sion

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Author(s): Bredesen, Anders; Brooks, Sam; Buffi, Jay; Cappucci, Winnie; Cherry, Mark; Clark, Chris; Evans, Gail; Hambloch, Heinrich; Jones, Colin; Kane, Paige; Margetts, Tony; Perez, Arthur "Randy"; Robertson, Peter; Samways, Kate; Selby, David; Wingate, Guy; Wyn, Sion

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.

Table of Contents

GAMP 5 Guide: Compliant GxP Computerized Systems (Polish Translation)

Pages: 360

Table of Contents pages: 1 2

Table of Contents pages: 1 2