ABSTRACT

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

chapter 1|17 pages

Introduction

chapter 2|14 pages

Organization and Management

chapter 3|23 pages

Supporting Processes

chapter 4|26 pages

Prospective Verification and Validation

chapter 7|26 pages

Design and Development

chapter 8|13 pages

Coding, Configuration, and Build

chapter 9|11 pages

Development Testing

chapter 10|25 pages

User Qualification and Authorization to Use

chapter 11|33 pages

Operation and Maintenance

chapter 12|12 pages

Phaseout and Withdrawal

chapter 13|28 pages

Electronic Records and Electronic Signatures

chapter 14|33 pages

Regulatory Inspections

chapter 15|27 pages

Compliance Strategies

chapter 16|20 pages

Capabilities, Measures, and Performance

chapter 17|6 pages

Practical Troubleshooting

chapter 18|6 pages

Concluding Remarks

chapter 22|15 pages

Case Study 4: Clinical Systems

chapter 29|14 pages

Case Study 11: Databases