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http://dx.doi.org/10.1201/9780203494240
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Front MatterAbstract - Hi-Res PDF (569 KB) - PDF w/links (545 KB)
Chapter 1. Why Validate?Abstract - Hi-Res PDF (481 KB) - PDF w/links (481 KB)
Chapter 2. History of Computer ValidationAbstract - Hi-Res PDF (481 KB) - PDF w/links (482 KB)
Chapter 3. Organization and ManagementAbstract - Hi-Res PDF (502 KB) - PDF w/links (502 KB)
Chapter 4. Supporting ProcessesAbstract - Hi-Res PDF (419 KB) - PDF w/links (419 KB)
Chapter 5. Prospective Validation Project DeliveryAbstract - Hi-Res PDF (673 KB) - PDF w/links (674 KB)
Chapter 6. Project Initiation and Validation DeterminationAbstract - Hi-Res PDF (572 KB) - PDF w/links (572 KB)
Chapter 7. Requirements Capture and Supplier (Vendor) SelectionAbstract - Hi-Res PDF (666 KB) - PDF w/links (667 KB)
Chapter 8. Design and DevelopmentAbstract - Hi-Res PDF (895 KB) - PDF w/links (895 KB)
Chapter 9. Coding, Configuration, and BuildAbstract - Hi-Res PDF (1424 KB) - PDF w/links (645 KB)
Chapter 10. Development TestingAbstract - Hi-Res PDF (404 KB) - PDF w/links (405 KB)
Chapter 11. User Qualification and Authorization to UseAbstract - Hi-Res PDF (685 KB) - PDF w/links (686 KB)
Chapter 12. Operation and MaintenanceAbstract - Hi-Res PDF (753 KB) - PDF w/links (754 KB)
Chapter 13. Phaseout and WithdrawalAbstract - Hi-Res PDF (361 KB) - PDF w/links (362 KB)
Chapter 14. Validation StrategiesAbstract - Hi-Res PDF (677 KB) - PDF w/links (678 KB)
Chapter 15. Electronic Records and Electronic SignaturesAbstract - Hi-Res PDF (646 KB) - PDF w/links (647 KB)
Chapter 16. Regulatory InspectionsAbstract - Hi-Res PDF (630 KB) - PDF w/links (631 KB)
Chapter 17. Capabilities, Measures, and PerformanceAbstract - Hi-Res PDF (710 KB) - PDF w/links (711 KB)
Chapter 18. Concluding RemarksAbstract - Hi-Res PDF (275 KB) - PDF w/links (275 KB)
Chapter 19. Case Study 1Abstract - Hi-Res PDF (1098 KB) - PDF w/links (412 KB)
Chapter 20. Case Study 2Abstract - Hi-Res PDF (831 KB) - PDF w/links (831 KB)
Chapter 21. Case Study 3Abstract - Hi-Res PDF (711 KB) - PDF w/links (712 KB)
Chapter 22. Case Study 4Abstract - Hi-Res PDF (336 KB) - PDF w/links (337 KB)
Chapter 23. Case Study 5Abstract - Hi-Res PDF (524 KB) - PDF w/links (525 KB)
Chapter 24. Case Study 6Abstract - Hi-Res PDF (408 KB) - PDF w/links (409 KB)
Chapter 25. Case Study 7Abstract - Hi-Res PDF (502 KB) - PDF w/links (503 KB)
Chapter 26. Case Study 8Abstract - Hi-Res PDF (444 KB) - PDF w/links (445 KB)
Chapter 27. Case Study 9Abstract - Hi-Res PDF (403 KB) - PDF w/links (407 KB)
Chapter 28. Case Study 10Abstract - Hi-Res PDF (345 KB) - PDF w/links (434 KB)
Chapter 29. Case Study 11Abstract - Hi-Res PDF (386 KB) - PDF w/links (387 KB)
Chapter 30. Case Study 12Abstract - Hi-Res PDF (389 KB) - PDF w/links (390 KB)
Chapter 31. Case Study 13Abstract - Hi-Res PDF (660 KB) - PDF w/links (660 KB)
Chapter 32. Case Study 14Abstract - Hi-Res PDF (469 KB) - PDF w/links (733 KB)
Chapter 33. Case Study 15Abstract - Hi-Res PDF (448 KB) - PDF w/links (448 KB)
Chapter 34. Case Study 16Abstract - Hi-Res PDF (464 KB) - PDF w/links (465 KB)
Chapter 35. Case Study 17Abstract - Hi-Res PDF (498 KB) - PDF w/links (499 KB)
Chapter 36. Case Study 18Abstract - Hi-Res PDF (729 KB) - PDF w/links (730 KB)
Chapter 37. Case Study 19Abstract - Hi-Res PDF (663 KB) - PDF w/links (664 KB)
Chapter 38. Case Study 20Abstract - Hi-Res PDF (576 KB) - PDF w/links (577 KB)
Chapter 39. Case Study 21Abstract - Hi-Res PDF (427 KB) - PDF w/links (428 KB)
Chapter 40. Case Study 22Abstract - Hi-Res PDF (306 KB) - PDF w/links (307 KB)
Chapter 41. Case Study 23Abstract - Hi-Res PDF (364 KB) - PDF w/links (365 KB)
Chapter 42. Case Study 24Abstract - Hi-Res PDF (305 KB) - PDF w/links (306 KB)
GlossaryAbstract - Hi-Res PDF (281 KB) - PDF w/links (282 KB)
