chapter 1 Why Validate? -- chapter 2 History of Computer Validation -- chapter 3 Organization and Management -- chapter 4 Supporting Processes -- chapter 5 Prospective Validation Project Delivery -- chapter 6 Project Initiation and Validation Determination -- chapter 7 Requirements Capture and Supplier (Vendor) Selection -- chapter 8 Design and Development -- chapter 9 Coding, Configuration, and Build -- chapter 10 Development Testing -- chapter 11 User Qualification and Authorization to Use -- chapter 12 Operation and Maintenance -- chapter 13 Phaseout and Withdrawal -- chapter 14 Validation Strategies -- chapter 15 Electronic Records and Electronic Signatures -- chapter 16 Regulatory Inspections -- chapter 17 Capabilities, Measures, and Performance -- chapter 18 Concluding Remarks -- chapter 19 Case Study 1: Computerized Analytical Laboratory Studies -- chapter 20 Case Study 2: Chromatography Data Systems -- chapter 21 Case Study 3: Laboratory Information Management Systems (LIMS) -- chapter 22 Case Study 4: Clinical Systems -- chapter 23 Case Study 5: Control Instrumentation -- chapter 24 Case Study 6: Programmable Logic Controllers -- chapter 25 Case Study 7: Industrial Personal Computers -- chapter 26 Case Study 8: Supervisory Control and Data Acquisition Systems -- chapter 27 Case Study 9: Distributed Control Systems -- chapter 28 Case Study 10: Electronic Batch Recording Systems (Manufacturing Execution Systems) -- chapter 29 Case Study 11: Integrated Applications -- chapter 30 Case Study 12: Building Management Systems -- chapter 31 Case Study 13: Engineering Management Systems -- chapter 32 Case Study 14: Spreadsheets -- chapter 33 Case Study 15: Databases -- chapter 34 Case Study 16: Electronic Document Management Systems (EDMS) -- chapter 35 Case Study 17: MRP II Systems -- chapter 36 Case Study 18: Marketing and Supply Applications -- chapter 37 Case Study 19: IT Infrastructure and Associated Services -- chapter 38 Case Study 20: Local and Wide Area Networks -- chapter 39 Case Study 21: Web Applications -- chapter 40 Case Study 22: Medical Devices and Their Automated Manufacture -- chapter 41 Case Study 23: Blood Establishment Computer Systems -- chapter 42 Case Study 24: Process Analytical Technology.