1st Edition

Automation and Validation of Information in Pharmaceutical Processing

By Joseph F. deSpautz Copyright 1998

    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.
  • 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


    Joseph F. deSpautz

    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