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 defines a complete life-cycle methodology that integrates equipment people and information presents concepts guidelines test plans example forms and application details for previously unavailable computer system validation of complex automated information systems introduces for the first time in depth PQ testing of integrated manufacturing execution (MES) and manufacturing resource planning (MRP) applications describes how human resource programs maximize productivity gains for automation initiatives discusses approaches to automating batch operations with process control systems using industry examples and applicable computer technology concepts 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 employs a business analysis standpoint on life-cycle planning to justify new automation projects including multiyear drug manufacturing plans documents the successful application of life-cycle methodologies to supply chain functions 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. . Language: English