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 .
ISBN:
9781420025996

9781280546358
Publication Information:
Hoboken : Informa Healthcare, 2000.
Physical Description:
1 online resource (547 pages)
Contents:
Front Cover; Contents; Preface; Foreword; Contributor List; 1. Paperless and Peopleless Plants: Trends in the Application of Computer Systems; 2. Developing an Information System Strategy; 3. Regulatory Expectations; 4. IT Validation Policy; 5. Demonstrating GxP Compliance; 6. Integrating Manufacturing Systems--A New Era in Production Control; 7. Validating Enterprise Asset Management Systems; 8. Validating Enterprise/Manufacturing Resource Planning Systems; 9. Validating Laboratory Information Management Systems; 10. Validating Electronic Document Management Systems.

11. Compliance for the Corporate IT Infrastructure12. Validating Local and Wide Area Networks; 13. Maintenance and Support of Validated IT Systems; 14. Auditing Suppliers of Standard Software Packages; 15. Auditing Software Integrators and Hardware Manufacturers; 16. Practical Implications of Electronic Signatures and Records; 17. Concluding Remarks: Validation in the 21st Century; Appendices; Index.
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E-Book 372727-2001 RS192 .V34 2000 EB
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