LEADER 02575nam 2200625Ia 450 001 9910462337703321 005 20200520144314.0 010 $a1-283-58350-X 010 $a9786613895950 010 $a0-252-09260-0 035 $a(CKB)2670000000241191 035 $a(EBL)3414075 035 $a(SSID)ssj0000711385 035 $a(PQKBManifestationID)11386547 035 $a(PQKBTitleCode)TC0000711385 035 $a(PQKBWorkID)10693504 035 $a(PQKB)11520431 035 $a(MiAaPQ)EBC3414075 035 $a(OCoLC)1058819415$z(OCoLC)811410286$z(OCoLC)870419011$z(OCoLC)923495309$z(OCoLC)961498114$z(OCoLC)962589024 035 $a(OCoLC)on1058819415 035 $a(MdBmJHUP)muse23902 035 $a(Au-PeEL)EBL3414075 035 $a(CaPaEBR)ebr10593747 035 $a(CaONFJC)MIL389595 035 $a(OCoLC)923495309 035 $a(EXLCZ)992670000000241191 100 $a20030910d2004 ub 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aHigh mountains rising$b[electronic resource] $eAppalachia in time and place /$fedited by Richard A. Straw and H. Tyler Blethen 210 $aUrbana $cUniversity of Illinois Press$dc2004 215 $a1 online resource (252 p.) 300 $aDescription based upon print version of record. 311 $a0-252-07176-X 320 $aIncludes bibliographical references (p. [221]-229) and index. 327 $aNative Americans / C. Clifford Boyd Jr. -- Pioneer settlement / H. Tyler Blethen -- Slavery and African Americans in the nineteenth century / John C. Inscoe -- The Civil War and Reconstruction / Gordon B. McKinney -- Industrialization / Ronald L. Lewis -- The Great Depression / Paul Salstrom -- Migration / Philip J. Obermiller -- Stereotypes / David C. Hsiung -- Music / Bill C. Malone -- Folklife / Michael Ann Williams -- Language / Michael Montgomery -- Literature / Ted Olson -- Religion / Deborah Vansau McCauley -- Modernization, 1940-2000 / Ronald D. Eller. 606 $aMountain life$zAppalachian Region 607 $aAppalachian Region$xHistory 607 $aAppalachian Region$xCivilization 607 $aAppalachian Region$xSocial conditions 608 $aElectronic books. 615 0$aMountain life 676 $a975/.68 701 $aStraw$b Richard Alan$0979704 701 $aBlethen$b Tyler$0979705 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910462337703321 996 $aHigh mountains rising$92234347 997 $aUNINA LEADER 05114oam 2200745I 450 001 9910792350003321 005 20230725023245.0 010 $a0-429-13762-1 010 $a1-282-56102-2 010 $a9786612561023 010 $a1-4200-8895-5 024 7 $a10.3109/9781420088953 035 $a(CKB)2670000000014356 035 $a(EBL)1186497 035 $a(OCoLC)843642693 035 $a(SSID)ssj0000364282 035 $a(PQKBManifestationID)11262315 035 $a(PQKBTitleCode)TC0000364282 035 $a(PQKBWorkID)10394805 035 $a(PQKB)10050079 035 $a(MiAaPQ)EBC1186497 035 $a(MiAaPQ)EBC510086 035 $a(Au-PeEL)EBL1186497 035 $a(CaPaEBR)ebr10373300 035 $a(CaONFJC)MIL256102 035 $a(OCoLC)680614244 035 $a(Au-PeEL)EBL510086 035 $a(OCoLC)609861125 035 $a(EXLCZ)992670000000014356 100 $a20180331d2010 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aPharmaceutical computer systems validation $equality assurance, risk management and regulatory compliance /$fedited by Guy Wingate 205 $a2nd ed. 210 1$aNew York :$cInforma Healthcare,$d2010. 215 $a1 online resource (773 p.) 300 $aRev. ed. of: Computer systems validation / editor, Guy Wingate. Boca Raton, Fla. : Interpharm/CRC, c2004. 311 $a1-4200-8894-7 320 $aIncludes bibliographical references and index. 327 $aFront Cover; Foreword to the Second Edition; Foreword to the First Edition; Preface; Contributor Biographies; Abbreviations; Contents; Chapter 1. Introduction; Chapter 2. Organization and Management; Chapter 3. Supporting Processes; Chapter 4. Prospective Verification and Validation; Chapter 5. Project Initiation and Compliance Determination; Chapter 6. Requirements Capture and Supplier (Vendor)Selection; Chapter 7. Design and Development; Chapter 8. Coding, Configuration, and Build; Chapter 9. Development Testing; Chapter 10. User Qualification and Authorization to Use 327 $aChapter 11. Operation and MaintenanceChapter 12. Phaseout and Withdrawal; Chapter 13. Electronic Records and Electronic Signatures; Chapter 14. Regulatory Inspections; Chapter 15. Compliance Strategies; Chapter 16. Capabilities, Measures, and Performance; Chapter 17. Practical Troubleshooting; Chapter 18. Concluding Remarks; Chapter 19. Case Study 1: Computerized Analytical Laboratory Systems; Chapter 20. Case Study 2: Chromatography Data Systems; Chapter 21. Case Study 3: Laboratory Information Management Systems; Chapter 22. Case Study 4: Clinical Systems 327 $aChapter 23. Case Study 5: Control and Monitoring InstrumentationChapter 24. Case Study 6: Process Control Systems; Chapter 25. Case Study 7: Manufacturing Execution Systems and Electronic Batch Records; Chapter 26. Case Study 8: Building Management Systems; Chapter 27. Case Study 9: Engineering Management Systems; Chapter 28. Case Study 10: Desktop Applications Including Spreadsheets; Chapter 29. Case Study 11: Databases; Chapter 30. Case Study 12: Electronic Document Management Systems; Chapter 31. Case Study 13: Enterprise Resource Planning Systems 327 $aChapter 32. Case Study 14: Marketing and Supply ApplicationsChapter 33. Case Study 15: IT Infrastructure and Associated Services; Chapter 34. Case Study 16: Internet/Intranet Applications; Chapter 35. Case Study 17: Medical Devices and Their Automated Manufacture; Chapter 36. Case Study 18: Blood Establishment Computer Systems; Chapter 37. Case Study 19: Process Analytical Technology; Chapter 38. Case Study 20: Computer Applications Supporting the Supply of Biotechnology Products; Glossary; Back Cover 330 $aThoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. 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