重磅Pharmaceutical Computer Systems Validation-Quality Assurance, Risk Manage...

Zucker

Pharmaceutical Computer Systems Validation-Quality Assurance, Risk Management and Regulatory Compliance 2nd-informa 2010，第二版是经典计算机化系统验证的第一版：
Computer Systems Validation-Quality Assurance, Risk Management, and Regulatory Compliance for Pharmaceutical and Healthcare Companies-CRC 2003的第二次出版，全面基于风险和科学的计算机化系统验证
绝对的重磅出击，计算机化系统的精神食粮。
申请版主置顶推荐。
1. Introduction 1
2. Organization and Management 18
3. Supporting Processes 32
4. Prospective Verification and Validation 55
5. Project Initiation and Compliance Determination 81
6. Requirements Capture and Supplier (Vendor) Selection 103
7. Design and Development 128
8. Coding, Configuration, and Build 154
9. Development Testing 167
10. User Qualification and Authorization to Use 178
11. Operation and Maintenance 203
12. Phaseout and Withdrawal 236
13. Electronic Records and Electronic Signatures 248
14. Regulatory Inspections 276
15. Compliance Strategies 309
16. Capabilities, Measures, and Performance 336
17. Practical Troubleshooting 356

18. Concluding Remarks 362
19. Case Study 1: Computerized Analytical Laboratory Systems 368
Ludwig Huber
20. Case Study 2: Chromatography Data Systems 382
Bob McDowall
21. Case Study 3: Laboratory Information Management Systems 406
Christopher Evans
22. Case Study 4: Clinical Systems 434
Chris Clark and Guy Wingate
23. Case Study 5: Control and Monitoring Instrumentation 449
Peter Coady and Tony de Claire
24. Case Study 6: Process Control Systems 479
Roger Buchanan and Mark Cherry
25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records 499
Peter Bosshard, Michael Schneider, and Robert Fretz
26. Case Study 8: Building Management Systems 515
John Andrews and Mark Foss
27. Case Study 9: Engineering Management Systems 535
Chris Reid
28. Case Study 10: Desktop Applications Including Spreadsheets 556
Arthur (Randy) Perez
29. Case Study 11: Databases 568
Arthur (Randy) Perez
30. Case Study 12: Electronic Document Management Systems 582
Robert Stephenson
31. Case Study 13: Enterprise Resource Planning Systems 596
Guy Wingate
32. Case Study 14: Marketing and Supply Applications 615
Louise Killa
33. Case Study 15: IT Infrastructure and Associated Services 650
Chris Reid and Barbara Nollau
34. Case Study 16: Internet/Intranet Applications 677
Winnie Cappucci, Ludwig Huber, and Arthur (Randy) Perez
35. Case Study 17: Medical Devices and Their Automated Manufacture 689
Guy Wingate and Tom Ryan

36. Case Study 18: Blood Establishment Computer Systems 703
Joan Evans
37. Case Study 19: Process Analytical Technology 716
Guy Wingate
38. Case Study 20: Computer Applications Supporting the Supply
of Biotechnology Products 726
Guy Wingate

LK8275610

沙发啊，好东西

Zucker

LK8275610 发表于 2015-9-21 19:51
沙发啊，好东西

很多人只知道下载却不知道回复，有一种悲哀的感觉。以后可能不会上传好东西了。

LK8275610

Zucker 发表于 2015-9-21 19:56
很多人只知道下载却不知道回复，有一种悲哀的感觉。以后可能不会上传好东西了。

下载不回复，就是耍流氓！

zhou04

谢谢楼主分享!

kmjiwa

这个必须得顶！

道路漫长黑暗

是不是少一个文件，怎么解不开呢

Zucker

道路漫长黑暗 发表于 2015-9-21 20:15
是不是少一个文件，怎么解不开呢

两个文件一起下载，放在一起就没有问题了。

安捷伦

谢谢分享，但是无法解压
这么放在一起？是放在一个文件夹里？但是也无法解压。请确认

Zucker

安捷伦 发表于 2015-9-21 20:59
谢谢分享，但是无法解压
这么放在一起？是放在一个文件夹里？但是也无法解压。请确认

嗯，如果这样还不行的话，就没有办法了，其他人应该是可以解压的。

红茶.

800页鸡肠文，我估计99.9999%的人看不下去。

Zucker

红茶. 发表于 2015-9-21 21:07
800页鸡肠文，我估计99.9999%的人看不下去。

当前计算机化系统验证是我们制药人验证行业的一个必备资料，少了就会差点什么。反正我是会看完的，其他人就各自努力了。

windy

谢谢分享，非常感谢

syhorchid

谢谢分享

nick123

因為兩個檔名一樣, 所以下載的人要自己改一下名稱, 才能解壓縮, 如第一個檔改名為1-1, 第二個檔改名為1-2 ,再一起解壓縮就可以了

yanzhengren

many thanks

飘摇的杂草

感谢分享 谢谢了

andrea5020

我也打不开呢            

87牛

多谢分享，学习

东岳红旗飘

谢谢分享，打不开。