eBook - PDF
Validating Corporate Computer Systems
Good IT Practice for Pharmaceutical Manufacturers
- 544 pages
- English
- PDF
- Available on iOS & Android
eBook - PDF
About this book
One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.
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Yes, you can access Validating Corporate Computer Systems by Guy Wingate in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.
Information
Table of contents
- Cover
- Title Page
- Copyright Page
- Table of 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
- Appendix