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.