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 r

chapter 1|17 pages


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 20|24 pages

Case Study 2: Chromatography Data Systems

ByBob McDowall

chapter 21|28 pages

Case Study 3: Laboratory Information Management Systems

ByChristopher Evans

chapter 22|15 pages

Case Study 4: Clinical Systems

ByChris Clark, Guy Wingate

chapter 23|30 pages

Case Study 5: Control and Monitoring Instrumentation

ByPeter Coady and Tony de Claire

chapter 24|20 pages

Case Study 6: Process Control Systems

ByRoger Buchanan, Mark Cherry

chapter 25|16 pages

Case Study 7: Manufacturing Execution Systems and Electronic Batch Records

ByPeter Bosshard, Michael Schneider, Robert Fretz

chapter 26|20 pages

Case Study 8: Building Management Systems

ByJohn Andrews, Mark Foss

chapter 27|21 pages

Case Study 9: Engineering Management Systems

ByChris Reid

chapter 28|12 pages

Case Study 10: Desktop Applications Including Spreadsheets

ByArthur (Randy) Perez

chapter 29|14 pages

Case Study 11: Databases

ByArthur (Randy) Perez

chapter 30|14 pages

Case Study 12: Electronic Document Management Systems

ByRobert Stephenson

chapter 31|19 pages

Case Study 13: Enterprise Resource Planning Systems

ByGuy Wingate

chapter 32|35 pages

Case Study 14: Marketing and Supply Applications

ByLouise Killa

chapter 33|27 pages

Case Study 15: IT Infrastructure and Associated Services

ByChris Reid, Barbara Nollau

chapter 34|12 pages

Case Study 16: Internet/Intranet Applications

ByWinnie Cappucci, Ludwig Huber, and Arthur (Randy) Perez

chapter 35|14 pages

Case Study 17: Medical Devices and Their Automated Manufacture

ByGuy Wingate, Tom Ryan

chapter 36|13 pages

Case Study 18: Blood Establishment Computer Systems

ByJoan Evans

chapter 37|10 pages

Case Study 19: Process Analytical Technology

ByGuy Wingate