Joseph F. Despautz

Automation and Validation of Information in Pharmaceutical Processing (eBook, PDF)

• Format: PDF

Produktbeschreibung

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 multiyeardrug manufacturing plans

documents the successful app

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 464
• Erscheinungstermin: 16. Juni 1998
• Englisch
• ISBN-13: 9781420000757
• Artikelnr.: 54253208

Autorenporträt

Joseph F. deSpautz

Inhaltsangabe

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