21 CFR Part 11 : complete guide to international computer validation compliance for the pharmaceutical industry
by
López, Orlando., author.
Title
:
21 CFR Part 11 : complete guide to international computer validation compliance for the pharmaceutical industry
Author
:
López, Orlando., author.
ISBN
:
9781135488765
9781135488710
9781135488758
Physical Description
:
1 online resource (xv, 243 pages)
Contents
:
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.
Subject Term
:
Computer software -- Validation,
Pharmaceutical industry.
Computer programs -- Verification.
Electronic Access
:
| Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
|---|
| Online Library | E-Book | 544298-1001 | RS192 .L67 2004 | | CRC E-Books |