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

Introduction Introduction, Joseph F. deSpautz Systems Planning for Automation Information 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 Automation CIM 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 Validation GMP 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 Automa