Automation and Validation of Information in Pharmaceutical Processing

by Joseph F. deSpautz

Overview

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 operat

Product Details

ISBN-13:	9781040159385
Publisher:	CRC Press
Publication date:	06/16/1998
Series:	Drugs and the Pharmaceutical Sciences
Sold by:	Barnes & Noble
Format:	eBook
Pages:	464
File size:	6 MB

About the Author

deSpautz, Joseph F., BE, MS (New York Univ)

Table of Contents

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 Automa

Editorial Reviews

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

It is likely to prove indispensible for anyone who is involved with baked goods, be it in production, product development or research.

Trends in Food Science & Technology

In the present volume, we see that the approach to…alleviating human suffering from central nervous system injury appears in many guises that may not immediately seem to be related to the central issue—regeneration in lower animals, developmental mechanisms, cell death, gene expression in peripheral nerves, treatment of degenerative diseases.

Bernice Grafstein

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

Pharm. Development & Tech.

Furnishes organizational, technological, validation, project management, and business perspectives on pharmaceutical information automation. Twenty-eight contributions demonstrate how to fulfill computer system validation requirements for hardware, applications, networks, data center operations, and complex software management practices in pharmaceutical manufacturing. Topics include how human resource programs maximize productivity gains for automatic initiatives, approaches to automating batch operations with process control systems, and application of life-cycle methodologies to supply chain functions. Annotation c. by Book News, Inc., Portland, Or.

Booknews

"
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

From the Publisher