ABSTRACT

Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality

chapter 1|21 pages

Why Validate?

chapter 2|29 pages

History of Computer Validation

chapter 3|27 pages

Organization and Management

chapter 4|26 pages

Supporting Processes

chapter 5|34 pages

Prospective Validation Project Delivery

chapter 8|43 pages

Design and Development

chapter 9|18 pages

Coding, Configuration, and Build

chapter 10|17 pages

Development Testing

chapter 11|35 pages

User Qualification and Authorization to Use

chapter 12|41 pages

Operation and Maintenance

chapter 13|16 pages

Phaseout and Withdrawal

chapter 14|29 pages

Validation Strategies

chapter 15|29 pages

Electronic Records and Electronic Signatures

chapter 16|33 pages

Regulatory Inspections

chapter 17|30 pages

Capabilities, Measures, and Performance

chapter 18|10 pages

Concluding Remarks

chapter 20|50 pages

Case Study 2: Chromatography Data Systems

chapter 22|18 pages

Case Study 4: Clinical Systems

chapter 23|32 pages

Case Study 5: Control Instrumentation

chapter 24|19 pages

Case Study 6: Programmable Logic Controllers

chapter 25|18 pages

Case Study 7: Industrial Personal Computers

chapter 27|16 pages

Case Study 9: Distributed Control Systems

chapter 29|12 pages

Case Study 11: Integrated Applications

chapter 30|20 pages

Case Study 12: Building Management Systems

chapter 32|21 pages

Case Study 14: Spreadsheets

chapter 33|18 pages

Case Study 15: Databases

chapter 35|24 pages

Case Study 17: MRP II Systems

chapter 38|24 pages

Case Study 20: Local and Wide Area Networks

chapter 39|15 pages

Case Study 21: Web Applications