Automation and Validation of Information in Pharmaceutical Processing

"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

• 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