Automation and Validation of Information in Pharmaceutical Processing (Drugs & the Pharmaceutical Sciences) (Drugs and the Pharmaceutical Sciences)

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This thoroughly authoritative work furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation from industry and system automation professionals-demonstrating how to fulfill computer system validation requirements for hardware, applications, networks, data center operations, and complex software management practices in pharmaceutical manufacturing. Explains how the Food and Drug Administration's latest Good Manufacturing Process guidelines supporting electronic identification and electronic signatures for batch record registration together with computer system technologies will influence pharmaceutical production automation! Designed to provide quick and easy access to a whole range of system development topics, Automation and Validation of Information in Pharmaceutical Processing xB7; defines a complete life-cycle methodology that integrates equipment, people, and information xB7; presents concepts, guidelines, test plans, example forms, and application details for previously unavailable computer system validation of complex automated information systems xB7; introduces, for the first time in depth, PQ testing of integrated manufacturing execution (MES) and manufacturing resource planning (MRP) applications xB7; describes how human resource programs maximize productivity gains for automation initiatives xB7; discusses approaches to automating batch operations with process control systems using industry examples and applicable computer technology concepts xB7; provides an outline for IQ, OQ, and PQ test plans for process control systems, including forms for use in testing instrumentation and distributed control system installation and operations xB7; employs a business analysis standpoint on life-cycle planning to justify new automation projects, including multiyear drug manufacturing plans xB7; documents the successful application of life-cycle methodologies to supply chain functions xB7; and much more! Together with references, tables, and drawings, Automation and Validation of Information in Pharmaceutical Processing is an essential, hands-on resource for pharmaceutical scientists, manufacturers, and engineers; drug quality assurance and regulatory personnel; project and program manufacturers; information system professionals and software developers and analysts; information technology practitioners; and graduate-level and continuing-education students in these disciplines.