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Books > Computing & IT > General theory of computing
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Automation and Validation of Information in Pharmaceutical Processing (Hardcover)
Loot Price: R5,434
Discovery Miles 54 340
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Automation and Validation of Information in Pharmaceutical Processing (Hardcover)
Series: Drugs and the Pharmaceutical Sciences
Expected to ship within 12 - 17 working days
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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
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.
General
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