About the Book:

Possibly the biggest computer validation challenge facing pharmaceutical manufacturers today is how to deal with large corporate systems. The magnitude of these systems means that the impact of validation noncompliance could bring a pharmaceutical manufacturer to its knees if a regulator orders that a system not be used. Organizations cannot generally afford to run stand-by, parallel systems, and new systems can take a year or more to institute. Validation must be right the first time. This book presents authoritative and practical advice on validating corporate computer systems from industry experts as well as case study material reflecting real-life pharmaceutical industry experience of corporate computer systems.

What You’ll Learn

• The increasing role of IT systems within the modem pharmaceutical manufacturing plant and the move toward paperless manufacturing.
• How to develop an information strategy, including the key element of Good IT Practices, which requires knowledge of regulatory expectations and the preparation of validation policies.
• The importance of demonstrating regulatory compliance.
• Case studies from experienced industry practitioners and the integration of applications: asset management systems, MRP II systems, LIMSs, document management systems, desktop infrastructure, and networks.
• How to maintain validated IT systems; conduct supplier audits for software packages, hardware manufacturers, and software integrators; and the practical implications of the U.S. Food and Drug Administration (FDA) regulation governing the use of electronic records and signatures (21 CFR II).
• Key practices and how they impact validation in the 21st century.    

Contents:

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.    Demonstration 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

About the Author: