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.
Table of Contents
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
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
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