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.