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21 CFR Part 11: Complete Guide to
International Computer Validation
Compliance for the Pharmaceutical
Industry
21 CFR Part 11: Complete Guide
to International Computer
Validation Compliance for the
Pharmaceutical Industry
Orlando López

Boca Raton London New York Washington, D.C.

 This edition published in the Taylor & Francis e-Library, 2005.
“To purchase your own copy of this or any of Taylor & Francis or Routledge's collection of
thousands of eBooks please go to www.eBookstore.tandf.co.uk.”
Library of Congress Cataloging-in-Publication Data
López, Orlando. 21 CFR Part 11: complete guide to international computer validation compliance
for the pharmaceutical industry/Orlando López. p. cm. Includes bibliographical references and
index. ISBN 0-8493-2243-X (alk. paper) 1. Pharmaceutical industry. 2. Computer software—
Validation, 3. Computer programs—Verification. I. Title: Twenty-one CFR Part Eleven. II. Title.
RS192.L67 2004 338.4'76151–dc22 2003063460
This book contains information obtained from authentic and highly regarded sources. Reprinted
material is quoted with permission, and sources are indicated. A wide variety of references are
listed. Reasonable efforts have been made to publish reliable data and information, but the author
and the publisher cannot assume responsibility for the validity of all materials or for the
consequences of their use.
Neither this book nor any part may be reproduced or transmitted in any form or by any means,
electronic or mechanical, including photocopying, microfilming, and recording, or by any
information storage or retrieval system, without prior permission in writing from the publisher.
The consent of CRC Press LLC does not extend to copying for general distribution, for promotion,
for creating new works, or for resale. Specific permission must be obtained in writing from CRC
Press LLC for such copying.
Direct all inquiries to CRC Press LLC, 2000 N.W. Corporate Blvd., Boca Raton, Florida 33431.
Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and
are used only for identification and explanation, without intent to infringe.
Visit the CRC Press Web site at www.crcpress.com
© 2004 by CRC Press LLC
No claim to original U.S. Government works

ISBN 0-203-02677-2 Master e-book ISBN

International Standard Book Number 0-8493-2243-X (Print Edition)

Library of Congress Card Number 2003063460

 Contents

Foreword vii
by Sion Wyn
Preface ix
by Orlando López
Publisher’s Note xi
Dedication xiii

Chapter 1 Introduction 1
Chapter 2 Validation Overview 5
Chapter 3 USA Regulatory Requirements for Computer Systems 15
Chapter 4 New Computer Systems Validation Model 24
Chapter 5 Computer Validation Management Cycle 28
Chapter 6 Computer Validation Program Organization 32
Chapter 7 The Computer Systems Validation Process 38
Chapter 8 Validation Project Plans and Schedules 46
Chapter 9 Inspections and Testing 53
Chapter 10 Qualifications 62
Chapter 11 SLC Documentation 90
Chapter 12 Relevant Procedural Controls 95
Chapter 13 Change Management 97
Chapter 14 Training 101
Chapter 15 Security 103
Chapter 16 Source Code 117
Chapter 17 Hardware/Software Suppliers Qualification 120
Chapter 18 Maintaining the State of Validation 124
Chapter 19 Part 11 Remediation Project 131
Chapter 20 Operational Checks 136
Chapter 21 Compliance Policy Guide (CPG) 7153.17 140
Chapter 22 Electronic Records 144
Chapter 23 Electronic Signatures 153
Chapter 24 Technologies Supporting Part 11 158
Chapter 25 All Together 166
Chapter 26 The Future 173

A Glossary of Terms 177

B Abbreviations and Acronyms 187
C Applicability of a Computer Validation Model 189
D Criticality and Complexity Assessment 197
E Sample Development Activities Grouped by Project Periods 206
F Administrative Procedures Mapped to Part 11 235
G Sample Audit Checklist for a Closed System 241
H Computer Systems Regulatory Requirements 244
I Technical Design Key Practices 267
Index 269
 Foreword

It has been my pleasure to know Orlando López as a friend for some years, and it has also
been my privilege to work with him in his specialty field, computer systems validation
and compliance. Orlando is well known in the industry as an enthusiastic advocate and
supporter of industry initiatives such as GAMP, and a valued contributor to various task
teams and committees.
He is a practitioner with valuable experience in tackling real challenges and dealing
with real-life problems. In this book, he illuminates the role of quality assurance, and
shows the importance of integrating the validation activities into the system life cycle
within a structured top-down approach.
This book reflects Orlando’s breadth of knowledge of and experience in the regulated
pharmaceutical and associated healthcare industries, software engineering, and quality
assurance. It covers the regulatory requirements, and the organisation, planning,
verification, and documentation activities required to meet those requirements. It also
describes the administrative and procedural controls required for compliance, as well as
introducing appropriate supporting technologies such as encryption and digital signatures.
Orlando is enthusiastic about his subject, and he is a mine of useful up-to-the-minute
information. He is always ready and willing to share this information and experience with
others for the benefit of the industry and the patient.
This book shows his commitment to the practical application of quality assurance and
engineering techniques in the development of systems that meet user and regulatory
requirements.
Sion Wyn
Conformity Limited
United Kingdom
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 Preface

This book speaks to all those involved in planning and undertaking computer systems
validation in the United States of America’s Food and Drug Administration (FDA)
regulated industries, mainly pharmaceuticals. The topics and discussion levels reflect
what I believe such people will find interesting or useful. My vision for this book is that it
reveals my perspective on how to perform computer systems validation, and gives my
readers a clear picture on how they must work effectively in a quality role in today’s
high-pressure, regulated environment.
Focusing on project management, I have chosen to include materials not normally
stressed in a computer systems book applicable to the FDA regulated industries.
Estimating, planning, and scheduling computer systems validation are hard to pin down,
because there is no true end to a project. More verification and testing are always
required, and there are serious risks associated with skipping them. Project managers
must be fully aware of these ‘trade-offs,’ and need to share this knowledge with their
teams. Efficiency is a major concern in this book.
Computer systems validation personnel must also deal with design errors. A program
that perfectly meets a lousy specification is a lousy program. Specifically for medical
devices, books on software reliability tend to set aside the user interface issue, and treat it
as the sole province of the human factor analyst. The reliability of a system is determined
by how all its various parts, including the people who use it, work together.
Your role as a project manager is to find and highlight problems in a product, with the
aim of improving its quality. You are one of the few who will have the required
information, or be directly able to examine the product in close detail, before it is
transferred to the regulated environment sector.
In the FDA-regulated environment, it is not acceptable for programmers or their
managers to deviate from standardized methodologies. Control programs for
manufacturing facilities must be well documented and thoroughly specified. Computer
systems must only change after careful control, since the electronic records associated
within these systems are now highly relevant to new FDA regulations. If manufacturing
systems fail, the quality of the product is in question: this can be catastrophic to the users,
patients whose lives depend largely on quality assurance staffs, and on huge computer
systems budgets being met.
It is fascinating how, in many highly standardized environments, a computer systems
validation (CSV) group works with the product just before it goes to production, or when
it has just been put into internal use.
This group is not involved in the drug development effort, their budgets are often tiny,
and their deadlines almost impossible to achieve. The quality assurance organization may
‘look down its collective nose’ at them and the CSV team is not involved with a product
for the time required to perform ‘real’ product life-cycle verification and testing.
With the introduction of 21 CFR Part 11 by the FDA, CSV practitioners are
encountering a new wave of computer systems validation. The computer validation
professional needs to be aware of quality engineering, project management, and computer
technologies. This book emphasizes the promotion of a conceptual understanding of
computer systems validation, and the need for evidence of such understanding in the form
of practical examples.
Commencing with a discussion of the regulatory requirements associated with the
practical foundation work for any project, this book introduces a model to determine the
Part 11 requirements for consideration during implementation; this is based on essential
characteristics of computer systems. This book then establishes a top-down approach to
the integration of computer systems validation strategies in support of a computer
systems validation project; focussing on the practical issues in computer systems
implementation and operational life project management; including relevant activities to
comply with Part 11, validation planning, and scheduling. Inspections and testing,
computer systems qualification, and sample qualification using the Good Automated
Manufacturing Practice (GAMP) categories of software, are all covered here.
The second section reviews documentation in relation to CSV and the procedural
controls required for regulated operations. Change management and control, training, and
security (introducing key technology-driven services such as user/data authentication and
access control), are followed by guidance on source code issues, and suppliers’
qualifications.
The book explains how technologies such as hashing, encryption, and digital
signatures can support Part 11. These technologies have not currently been implemented
to any extent in the FDA-regulated environments.
Finally, my vision of the integration of project management and computer systems
validation is based on hands-on experience and the knowledge accumulated from more
than 20 years experience in software engineering and software quality engineering. The
author wishes to acknowledge and express appreciation to all of the people who, during
the last 30 years, have contributed to this body of knowledge, and who laid down the
crucial groundwork for this computer systems validation book.
Orlando López, Executive Consultant
J&J Networking and Computing Services
Raritan, New Jersey
 Publisher’s Note

The FDA withdrew its last guidance document in the series on electronic copies of
electronic records in February 2003. But it did NOT withdraw the 21 CFR Part 11 Rule,
which is still in force, and must be complied with: the FDA is still inspecting companies
for compliance and none of the multi-million dollar fines imposed by the FDA for non-
compliance have been revoked. Nor have any of the preceding warning letters been
recalled.
This Professional Edition of a pragmatic guide is designed to enlighten the industry at
large, which suffers somewhat from the confusion created by earlier guidance documents
now withdrawn. Written by an international expert in computer software and computer
validation, it will become a classic of its kind when properly used to help companies
implement their compliance requirements to meet the FDA and the MCA.
On September 3, 2003 the FDA released the final guidance on the ‘Scope and
Application’ of 21 CFR Part 11. Comments from industry played a large role in the
changes that the FDA made between the draft version and the new final version.
Significant clarification was also established on the definition of legacy systems and on
‘enforcement discretion’.
Despite these clarifications, there is still a great deal of uncertainty remaining
regarding what is expected by the Agency in the long term and how to proceed
logistically with a risk-based remediation for Part 11. To access these guidelines, please
visit the following website: http:/www.fda.gov/cder/guidance/5667fnl.htm.
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