Automation and Validation of Information in Pharmaceutical Processing

✍ Scribed by Joseph F. deSpautz (Author)

• Publisher: CRC Press
• Year: 1998
• Leaves: 464
• Edition: 1
• Category: Library

✦ Synopsis

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

✦ 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

✦ Subjects

Bioscience;Pharmaceutical Science;Analysis & Pharmaceutical Quality;Pharmaceutical Technology;Computer Software-Pharmaceutical Science