Computer Systems Validation 在线电子书 pdf 下载 txt下载 epub 下载 mobi 下载 2024

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Wingate, Guy (EDT) 作者

CRC Pr I Llc

译者

2003-12 出版日期

1032 页数

$ 644.10 价格

HRD

丛书系列

9780849318719 图书编码

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发表于2024-09-21

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Computer Systems Validation 在线电子书 epub 下载 mobi 下载 pdf 下载 txt 下载 2024

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Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality assured, and validated. The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture. The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.

Computer Systems Validation 在线电子书下载 mobi epub pdf txt 在线电子书下载

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