Validating corporate computer systems : good IT practice for pharmaceutical manufacturers / editor, Guy Wingate.
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| Online Access: |
Full Text (via Taylor & Francis) |
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| Format: | eBook |
| Language: | English |
| Published: |
Englewood, Colo. :
Interpharm Press,
©2000.
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| Subjects: |
Table of 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 Infrastructure""; ""12. 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""