Ispe Gamp R 5 A Risk Based Approach To Compliant Gxp Computerized Systems
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International IT Regulations and Compliance
Author: Siri H. Segalstad
language: en
Publisher: John Wiley & Sons
Release Date: 2008-11-20
Standards, technologies, and requirements for computer validation have changed dramatically in recent years, and so have the interpretation of the standards and the understanding of the processes involved. International IT Regulations and Compliance brings together current thinking on the implementation of standards and regulations in relation to IT for a wide variety of industries. The book provides professionals in pharmaceutical and semiconductor industries with an updated overview of requirements for handling IT systems according to various Quality Standards and how to ?translate? these requirements in the regulations.