Automation and Validation of Information in Pharmaceutical Processing
Joseph F. deSpautz · 1998
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