Automation and validation of information in pharmaceutical processing

著者

    • DeSpautz, Joseph F.

書誌事項

Automation and validation of information in pharmaceutical processing

edited by Joseph F. deSpautz

(Drugs and the pharmaceutical sciences, v. 90)

Marcel Dekker, 1998

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注記

Includes bibliographical references and index

内容説明・目次

内容説明

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.

目次

Introduction Introduction, Joseph F. deSpautz Systems Planning for Automation Information Systems Planning, Colman O'Murchu Information Technology Planning for Electronic Batch Record Operations, Joseph F. deSpautz Human Factors and Information Systems, James L. Vesper Instrumentation and Process Control System Strategy, David J. Adler Automation Life Cycle Is More than Looking at Cost: It's a New Tool for Competitiveness, Steven B. Williams and David J. Adler Managing the Manufacturing Control Domain, Sean M. Megley Distributed Client/Server-Based Batch Control System Applied as Part of the Enterprise Solution Suite Using Technology, Baha Korkmaz Implementing Automation CIM Architecture for Validated Manufacturing Systems, Joseph F. deSpautz System Implementation Plan for Validated Manufacturing Systems, Joseph F. deSpautz Enhanced Regulatory Compliance Using Manufacturing Execution Systems, Frederick R. Bickel and Richard E. Blanchette Investing in Education and Training, James L. Vesper Documenting Education and Training, James L. Vesper Evaluation and Certification, James L. Vesper Computer Systems Validation GMP Regulations and Computer Validation, Teri Stokes Validation Concepts, Kenneth S. Kovacs and Joseph F. deSpautz Management's Role in Computer Validation: Policy and Procedures, Teri Stokes Electronic Records, Electronic Signatures, and FDA Regulation Final Rule, Teri Stokes Applied Computer Validation Plan for Manufacturing Execution Systems, Frederick R. Bickel and Richard E. Blanchette One Keyboard Pounder's Views on Validation, Joseph A. Hercamp A Validation Plan for Process Automation, Kenneth S. Kovacs and Joseph F. deSpautz Performance Qualification Testing of Integrated MRP/MES, Joseph F. deSpautz and Kenneth S. Kovacs Life Cycle Documentation for MRP-MES-PCS Integration, Joseph F. deSpautz and Kenneth S. Kovacs Supply Chain Automation Research and Development Automation, Jeffrey S. Gramm Plant Design and Engineering, Jack Conaway Logistics, Joseph J. Kowalski Bringing Distributed Control Systems into the World of Client-Server Batch Control, Anthony R. Gonzalez and Mark Castro Batch Process Automation, Teddy H. Tom and Kenneth S. Kovacs

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