21 CFR Part 11 : complete guide to international computer validation compliance for the pharmaceutical industry için kapak resmi
Başlık:
21 CFR Part 11 : complete guide to international computer validation compliance for the pharmaceutical industry
Yazar:
López, Orlando., author.
ISBN:
9781135488765

9781135488710

9781135488758
Fiziksel Tanımlama:
1 online resource (xv, 243 pages)
İçerik:
chapter 1 Introduction -- chapter 2 Validation Overview -- chapter 3 USA Regulatory Requirements for Computer Systems1 -- chapter 4 New Computer Systems Validation Model1 -- chapter 5 Computer Validation Management Cycle -- chapter 6 Computer Validation Program Organization -- chapter 7 The Computer Systems Validation Process -- chapter 8 Validation Project Plans and Schedules -- chapter 9 Inspections and Testing -- chapter 10 Qualifications -- chapter 11 SLC Documentation -- part 12 Relevant Procedural Controls -- chapter 13 Change Management -- part 14 Training -- chapter 15 Security -- chapter 16 Source Code -- chapter 17 Hardware/Software Suppliers Qualification -- chapter 18 Maintaining the State of Validation -- chapter 19 Part 11 Remediation Project -- chapter 20 Operational Checks -- chapter 21 Compliance Policy Guide (CPG) 7153.17 -- chapter 22 Electronic Records -- chapter 23 Electronic Signatures -- chapter 24 Technologies Supporting Part 111,2 -- chapter 25 All Together -- chapter 26 The Future.
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E-Kitap 544298-1001 RS192 .L67 2004
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