Del i serien Drugs and the Pharmaceutical Sciences

Automation and Validation of Information in Pharmaceutical Processing

Inbunden, Engelska, 1998

3 789 kr

Beställningsvara. Skickas inom 10-15 vardagar. Fri frakt för medlemmar vid köp för minst 249 kr.

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 Processingdefines 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.

Produktinformation

Utgivningsdatum1998-06-16
Mått152 x 229 x 29 mm
Vikt1 020 g
FormatInbunden
SpråkEngelska
SerieDrugs and the Pharmaceutical Sciences
Antal sidor464
FörlagTaylor & Francis Inc
ISBN9780824701192

Tillhör följande kategorier

Systemvetenskap och AI inom Data och IT
Tillverkningsteknik inom Naturvetenskap och teknik
Farmakologi inom Medicin

IntroductionIntroduction, Joseph F. deSpautzSystems Planning for AutomationInformation Systems Planning, Colman O'MurchuInformation Technology Planning for Electronic Batch Record Operations, Joseph F. deSpautzHuman Factors and Information Systems, James L. VesperInstrumentation and Process Control System Strategy, David J. AdlerAutomation Life Cycle Is More than Looking at Cost: It's a New Tool for Competitiveness, Steven B. Williams and David J. AdlerManaging the Manufacturing Control Domain, Sean M. MegleyDistributed Client/Server-Based Batch Control System Applied as Part of the Enterprise Solution Suite Using Technology, Baha KorkmazImplementing AutomationCIM Architecture for Validated Manufacturing Systems, Joseph F. deSpautzSystem Implementation Plan for Validated Manufacturing Systems, Joseph F. deSpautzEnhanced Regulatory Compliance Using Manufacturing Execution Systems, Frederick R. Bickel and Richard E. BlanchetteInvesting in Education and Training, James L. VesperDocumenting Education and Training, James L. VesperEvaluation and Certification, James L. VesperComputer Systems ValidationGMP Regulations and Computer Validation, Teri StokesValidation Concepts, Kenneth S. Kovacs and Joseph F. deSpautzManagement's Role in Computer Validation: Policy and Procedures, Teri StokesElectronic Records, Electronic Signatures, and FDA Regulation Final Rule, Teri StokesApplied Computer Validation Plan for Manufacturing Execution Systems, Frederick R. Bickel and Richard E. BlanchetteOne Keyboard Pounder's Views on Validation, Joseph A. HercampA Validation Plan for Process Automation, Kenneth S. Kovacs and Joseph F. deSpautzPerformance Qualification Testing of Integrated MRP/MES, Joseph F. deSpautz and Kenneth S. KovacsLife Cycle Documentation for MRP-MES-PCS Integration, Joseph F. deSpautz and Kenneth S. KovacsSupply Chain AutomationResearch and Development Automation, Jeffrey S. GrammPlant Design and Engineering, Jack ConawayLogistics, Joseph J. KowalskiBringing Distributed Control Systems into the World of Client-Server Batch Control, Anthony R. Gonzalez and Mark CastroBatch Process Automation, Teddy H. Tom and Kenneth S. Kovacs

"For many workers in the pharmaceutical industry, the present volume will give them more information on the validation aspects of process automation than they ever dreamed possible. However, for those whose lives center around such work, the editor has developed a very comprehensive handbook. There is little about the planning, execution, and validation of automated processes that is lacking from this book, and I would think that it would become the little red book carried by every worker seeking entry into this area."-Pharmaceutical Development and Technology"…gives a splendid overview on information technology in the pharmaceutical industry….It is worth reading, or rather working with, the book."- International Journal of Production Research