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Pharmaceutical computer systems vali...

Wingate, Guy.

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Pharmaceutical computer systems validation = quality assurance, risk management and regulatory compliance /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Pharmaceutical computer systems validation/ edited by Guy Wingate.
其他題名:	quality assurance, risk management and regulatory compliance /
其他作者:	Wingate, Guy.
出版者:	New York :Informa Healthcare, : c2010.,
面頁冊數:	xxxi, 765 p. :ill.
附註:	Rev. ed. of: Computer systems validation / editor, Guy Wingate. Boca Raton, Fla. : Interpharm/CRC, c2004.
內容註:	1. Introduction -- 2. Organization and management -- 3. Supporting processes -- 4. Prospective verification and validation -- 5. Project initiation and compliance determination -- 6. Requirements capture and supplier (vendor) selection -- 7. Design and development -- 8. Coding, configuration, and build -- 9. Development testing -- 10. User qualification and authorization to use -- 11. Operation and maintenance -- 12. Phaseout and withdrawal -- 13. Electronic records and electronic signatures -- 14. Regulatory inspections -- 15. Compliance strategies -- 16. Capabilities, measures, and performance -- 17. Practical troubleshooting -- 18. Concluding remarks -- 19. Case study 1 : computerized analytical laboratory systems / Ludwig Huber -- 20. Case study 2 : chromatography data systems / Bob McDowall -- 21. Case study 3 : laboratory information management systems / Christopher Evans -- 22. Case study 4 : clinical systems / Chris Clark and Guy Wingate -- 23. Case study 5 : control and monitoring instrumentation / Peter Coady and Tony de Claire -- 24. Case study 6 : process control systems / Roger Buchanan and Mark Cherry -- 25. Case study 7 : manufacturing execution systems and electronic batch records / Peter Bosshard, Michael Schneider, and Robert Fretz -- 26. Case study 8 : building management systems / John Andrews and Mark Foss -- 27. Case study 9 : engineering management systems / Chris Reid -- 28. Case study 10 : desktop applications including spreadsheets / Arthur (Randy) Perez -- 29. Case study 11 : databases / Arthur (Randy) Perez -- 30. Case study 12 : electronic document management systems / Robert Stephenson -- 31. Case study 13 : enterprise resource planning systems / Guy Wingate -- 32. Case study 14 : marketing and supply applications / Louise Killa -- 33. Case study 15 : IT infrastructure and associated services / Chris Reid and Barbara Nollau -- 34. Case study 16 : internet/intranet applications / Winnie Cappucci, Ludwig Huber, and Arthur (Randy) Perez -- 35. Case study 17 : medical devices and their automated manufacture / Guy Wingate and Tom Ryan -- 36. Case study 18 : blood establishment computer systems / Joan Evans -- 37. Case study 19 : process analytical technology / Guy Wingate -- 38. Case study 20 : computer applications supporting the supply of biotechnology products / Guy Wingate.
標題:	Pharmaceutical industry - Management. -
電子資源:	http://marc.crcnetbase.com/isbn/9781420088953Distributed by publisher. Purchase or institutional license may be required for access.
ISBN:	9781420088953 (ebook : PDF)

Pharmaceutical computer systems validation = quality assurance, risk management and regulatory compliance /
Pharmaceutical computer systems validationquality assurance, risk management and regulatory compliance /[electronic resource] :edited by Guy Wingate. - 2nd ed. - New York :Informa Healthcare,c2010. - xxxi, 765 p. :ill.

Rev. ed. of: Computer systems validation / editor, Guy Wingate. Boca Raton, Fla. : Interpharm/CRC, c2004.

Includes bibliographical references and index.

1. Introduction -- 2. Organization and management -- 3. Supporting processes -- 4. Prospective verification and validation -- 5. Project initiation and compliance determination -- 6. Requirements capture and supplier (vendor) selection -- 7. Design and development -- 8. Coding, configuration, and build -- 9. Development testing -- 10. User qualification and authorization to use -- 11. Operation and maintenance -- 12. Phaseout and withdrawal -- 13. Electronic records and electronic signatures -- 14. Regulatory inspections -- 15. Compliance strategies -- 16. Capabilities, measures, and performance -- 17. Practical troubleshooting -- 18. Concluding remarks -- 19. Case study 1 : computerized analytical laboratory systems / Ludwig Huber -- 20. Case study 2 : chromatography data systems / Bob McDowall -- 21. Case study 3 : laboratory information management systems / Christopher Evans -- 22. Case study 4 : clinical systems / Chris Clark and Guy Wingate -- 23. Case study 5 : control and monitoring instrumentation / Peter Coady and Tony de Claire -- 24. Case study 6 : process control systems / Roger Buchanan and Mark Cherry -- 25. Case study 7 : manufacturing execution systems and electronic batch records / Peter Bosshard, Michael Schneider, and Robert Fretz -- 26. Case study 8 : building management systems / John Andrews and Mark Foss -- 27. Case study 9 : engineering management systems / Chris Reid -- 28. Case study 10 : desktop applications including spreadsheets / Arthur (Randy) Perez -- 29. Case study 11 : databases / Arthur (Randy) Perez -- 30. Case study 12 : electronic document management systems / Robert Stephenson -- 31. Case study 13 : enterprise resource planning systems / Guy Wingate -- 32. Case study 14 : marketing and supply applications / Louise Killa -- 33. Case study 15 : IT infrastructure and associated services / Chris Reid and Barbara Nollau -- 34. Case study 16 : internet/intranet applications / Winnie Cappucci, Ludwig Huber, and Arthur (Randy) Perez -- 35. Case study 17 : medical devices and their automated manufacture / Guy Wingate and Tom Ryan -- 36. Case study 18 : blood establishment computer systems / Joan Evans -- 37. Case study 19 : process analytical technology / Guy Wingate -- 38. Case study 20 : computer applications supporting the supply of biotechnology products / Guy Wingate.

Mode of access: World Wide Web.

ISBN: 9781420088953 (ebook : PDF)Subjects--Topical Terms:

802042
Pharmaceutical industry
--Management.Index Terms--Genre/Form:

542853
Electronic books.

Pharmaceutical computer systems validation = quality assurance, risk management and regulatory compliance /
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020 $a 9781420088953 (ebook : PDF)
035 $a CRC00HE8895PDF
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092 $a 615.10684 $b P536
245 0 0 $a Pharmaceutical computer systems validation $h [electronic resource] : $b quality assurance, risk management and regulatory compliance / $c edited by Guy Wingate.
250 $a 2nd ed.
260 $a New York : $b Informa Healthcare, $c c2010.
300 $a xxxi, 765 p. : $b ill.
500 $a Rev. ed. of: Computer systems validation / editor, Guy Wingate. Boca Raton, Fla. : Interpharm/CRC, c2004.
504 $a Includes bibliographical references and index.
505 0 $a 1. Introduction -- 2. Organization and management -- 3. Supporting processes -- 4. Prospective verification and validation -- 5. Project initiation and compliance determination -- 6. Requirements capture and supplier (vendor) selection -- 7. Design and development -- 8. Coding, configuration, and build -- 9. Development testing -- 10. User qualification and authorization to use -- 11. Operation and maintenance -- 12. Phaseout and withdrawal -- 13. Electronic records and electronic signatures -- 14. Regulatory inspections -- 15. Compliance strategies -- 16. Capabilities, measures, and performance -- 17. Practical troubleshooting -- 18. Concluding remarks -- 19. Case study 1 : computerized analytical laboratory systems / Ludwig Huber -- 20. Case study 2 : chromatography data systems / Bob McDowall -- 21. Case study 3 : laboratory information management systems / Christopher Evans -- 22. Case study 4 : clinical systems / Chris Clark and Guy Wingate -- 23. Case study 5 : control and monitoring instrumentation / Peter Coady and Tony de Claire -- 24. Case study 6 : process control systems / Roger Buchanan and Mark Cherry -- 25. Case study 7 : manufacturing execution systems and electronic batch records / Peter Bosshard, Michael Schneider, and Robert Fretz -- 26. Case study 8 : building management systems / John Andrews and Mark Foss -- 27. Case study 9 : engineering management systems / Chris Reid -- 28. Case study 10 : desktop applications including spreadsheets / Arthur (Randy) Perez -- 29. Case study 11 : databases / Arthur (Randy) Perez -- 30. Case study 12 : electronic document management systems / Robert Stephenson -- 31. Case study 13 : enterprise resource planning systems / Guy Wingate -- 32. Case study 14 : marketing and supply applications / Louise Killa -- 33. Case study 15 : IT infrastructure and associated services / Chris Reid and Barbara Nollau -- 34. Case study 16 : internet/intranet applications / Winnie Cappucci, Ludwig Huber, and Arthur (Randy) Perez -- 35. Case study 17 : medical devices and their automated manufacture / Guy Wingate and Tom Ryan -- 36. Case study 18 : blood establishment computer systems / Joan Evans -- 37. Case study 19 : process analytical technology / Guy Wingate -- 38. Case study 20 : computer applications supporting the supply of biotechnology products / Guy Wingate.
530 $a Also available in print edition.
538 $a Mode of access: World Wide Web.
650 0 $a Pharmaceutical industry $x Management. $3 802042
650 0 $a Pharmaceutical industry $x Data processing. $3 812162
650 0 $a Health facilities $x Risk management. $3 797006
650 0 $a Risk management $x Data processing. $3 749272
655 7 $a Electronic books. $2 lcsh $3 542853
700 1 $a Wingate, Guy. $3 916458
730 0 $a Computer systems validation. $3 2123240
776 1 $z 9781420088946 (hardcover : alk. paper) $z 1420088947 (hardcover : alk. paper)
856 4 0 $u http://marc.crcnetbase.com/isbn/9781420088953 $q application/PDF $z Distributed by publisher. Purchase or institutional license may be required for access.