EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP - Image 1

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CRC Press EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

Name: EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
Brand: CRC Press
Price: 160.0 GBP
Availability: InStock

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Description

Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems. The purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and use of computer systems. EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP supplies practical information to facilitate compliance with computer system GMP requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program. The ideas presented in this book are based on the author’s 25 years of experience with computer validation in the healthcare industry with various computer systems development, maintenance, and quality functions. The bookdetails a practical approach to increase efficiency and to ensure that software development and maintenance are achieved correctly. Examining the implementation of the computer systems validation entirely based on EU Annex 11, the book includes examples from laboratory, clinical, and manufacturing computer systems. It also discusses electronic record integrity associated with stored information.

Product Specifications

Brand: CRC Press
Format: hardcover
ASIN: 1482243628
Category: Books > Subjects > Business, Finance & Law > Law > European Union (EU)
Domain: Amazon UK
Release Date: 06 April 2015
Listed Since: 28 August 2014

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CRC Press EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

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