Cover image for Validating corporate computer systems : good IT practice for pharmaceutical manufacturers
Title:
Validating corporate computer systems : good IT practice for pharmaceutical manufacturers
Author:
Wingate, Guy, editor.
ISBN:
9780429134173
Physical Description:
1 online resource
Contents:
1. Paperless and peopleless plants : trends in the application of computer systems / Gert Moelgaard -- 2. Developing an information system strategy / Chris Reid, Norman Harris, and Brian Ravenscroft -- 3. Regulatory expectations / Heinrich Hambloch -- 4. IT validation policy / Heinrich Hambloch -- 5. Demonstrating GxP compliance / Guy Wingate -- 6. Integrating manufacturing systems : a new era in production control / Christopher Evans and David Stokes -- 7. Validating enterprise asset management systems / Chris Reid and Tony Richards -- 8. Validating enterprise/manufacturing resource planning systems / Owen Salvage and Melanie Snelham -- 9. Validating laboratory information management systems / Christopher Evans -- 10. Validating electronic document management systems / Roger Dean and Richard Mitchell -- 11. Compliance for the corporate IT infrastructure / Peter Wilks -- 12. Validating local and wide area networks / Nicola Signorile -- 13. Maintenance and support of validated IT systems / Erna Koelman, Kees de Jong, and Kees Piket -- 14. Auditing suppliers of standard software packages / Anton Dillinger, Robert Kampfmann, and Torsten Wichmann -- 15. Auditing software integrators and hardware manufacturers / Howard Garston Smith -- 16. Practical implications of electronic signatures and records / David Selby -- 17. Concluding remarks : validation in the 21st century / Guy Wingate.
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E-Book 540986-1001 RS192 .V35 2000
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