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

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

"

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

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.

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