新书分享

Zucker

这是计算机化系统和电子数据/签名内比较知名的，真正的Expert-R. D. McDowall写的：Validation of Chromatography Data Systems Ensuring Data Integrity, Meeting Business and Regulatory Requirements 2nd Edition，也可以访问如下地址：http://gen.lib.rus.ec/book/index ... 5D037A831374246911E
网速因网络而异，大家懂的。
还有就是这个网站上有非常非常多的好东东，会英文的一定有大量的收获，网速不行或者慢请翻墙。方法自己百度吧
还请先看目录，再下载，主要是以色谱数据（液相、气相等为主）系统为例。熟悉色谱并且负责验证的一定会有收获吧。

目录如下：
Chapter 1 How to Use this Book
Chapter 2 What is a CDS? The Past, Present and Future
Chapter 3 Laboratory Informatics and the Role of a CDS
Chapter 4 Applicable GXP Regulations and Guidance for CSV
Chapter 5 Concepts of Computer Validation
Chapter 6 Understanding Software Categories and System Life Cycles

Chapter 7 Ensuring Data Integrity for Chromatography Data Systems

Chapter 8 CDS Validation: Managing System Risk
Chapter 9 Working Electronically and Using Electronic Signatures
Chapter 10 Writing the User and System Requirements
Chapter 11 Controlling the Validation
Chapter 12 System Selection
Chapter 13 Assessing the CDS Supplier
Chapter 14 Negotiating the Contract and Purchasing the System
Chapter 15 Planning the Installation of the System
Chapter 16 CSV Risk Management Requirements Level Assessment
Chapter 17 Importance of the Traceability Matrix
Chapter 18 Writing Configuration Specifications
Chapter 19 Writing the Technical Specification
Chapter 20 Installing and Integrating System Components
Chapter 21 Designing the User Acceptance Test Suite
Chapter 22 Writing Test Scripts and Test Cases
Chapter 23 Executing Test Scripts and Reporting the Results
Chapter 24 User Training and System Documentation
Chapter 25 IT Support for a CDS
Chapter 26 System Description
Chapter 27 Defining Electronic Records and Raw Data for a CDS
Chapter 28 Writing the Validation Summary Report
Chapter 29 Integration in a Regulated Environment
Chapter 30 User Account Management
Chapter 31 Incident and Problem Management
Chapter 32 Change Control and Configuration Management
Chapter 33 Periodic Review of the CDS
Chapter 34 CDS Records Retention
Chapter 35 CDS System Retirement
Chapter 36 CDS Data Migration
Chapter 37 Retrospective Validation

静水蓝心

厉害了

xqliu

学习一下啦，谢谢提供分享。

一沙一叶

免费下载么？我打开有点乱

Zucker

一沙一叶 发表于 2017-2-18 18:19
免费下载么？我打开有点乱

这个你可以放心，我试过不下100次了，不需要注册，不需要账户，直接下载或者用迅雷都可以。绝对不会有啥啥的呢

雪松无悔

谢谢楼主分享。

syhorchid

谢谢分享

hhhy

打不开，过时了？

Zucker

hhhy 发表于 2017-2-22 22:11
打不开，过时了？

没有呢，可以打开的

pine001

thank you landlord for sharing, god bless you

呼呼_802

没弄明白怎么下载啊，
上面的几个压缩文件下载了打不开啊

18810536953

谢谢提供分享

呼呼_802

上面的几个压缩文件下载了打不开啊

Zucker

呼呼_802 发表于 2017-4-21 16:40
上面的几个压缩文件下载了打不开啊

需要全部下载之后一起才能解压的啥

qqqqqqqqqqqq

1111111111111111

meiyududu

谢谢分享。。。

werewolfman

学习。

破晓之钟

学习一下啦，谢谢提供分享。

罗伊鲱

都是同一个网站：
http://libgen.io/
http://gen.lib.rus.ec/
http://libgen.pw/
http://bookfi.org/
http://bookzz.org/
http://p4swjett52gpafbbdkxwktfcw ... mc2hbvj6nq.b32.i2p/
现在能下免费书的网站很少了。以前的Rapidshare 2015年3月关闭。

406138035

谢谢分享