Please note: In order to keep Hive up to date and provide users with the best features, we are no longer able to fully support Internet Explorer. The site is still available to you, however some sections of the site may appear broken. We would encourage you to move to a more modern browser like Firefox, Edge or Chrome in order to experience the site fully.

Supporting your high street Find out how »
EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP, Hardback Book

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

Hardback

Available to Order - This title is available to order, with delivery expected within 2 weeks

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 book details 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.

Information

Other Formats

£210.00

Available to Order - This title is available to order, with delivery expected within 2 weeks
Add to Basket
Sign in to add to wishlist
 
Free Home Delivery

on all orders

 
Pick up orders

from local bookshops

Information