Data Integrity and Compliance

José Rodríguez-Pérez

Description

Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial.
The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies' position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.

Sujets

• Business
• Qualité, hygiène, sécurité, environnement
• Total Quality Management
• Gestion et management
• Economics

Informations

• Publié par: ASQ Quality Press
• Date de parution: 08 mai 2019
• Nombre de lectures: 0
• EAN13: 9781951058470
• Langue: English
• Poids de l'ouvrage: 3 Mo

Extrait

Data Integrity and Compliance

A Primer for Medical Product Manufacturers

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To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our website at http://www.asq.org/quality-press.

Data Integrity and Compliance

A Primer for Medical Product Manufacturers

José Rodríguez-Pérez, PhD

ASQ Quality Press Milwaukee, Wisconsin

American Society for Quality, Quality Press, Milwaukee 53203 © 2019 by ASQ. Printed in 2019. All rights reserved. Printed in the United States of America. 22 21 20 19 5 4 3 2 1

Library of Congress Cataloging-in-Publication Data

Names: Rodríguez Pérez, José, 1961–author. | American Society for Quality, issuing body. Title: Data integrity and compliance : a primer for medical product manufacturers /  by Jose Rodriguez-Perez. Description: Milwaukee, Wisconsin : ASQ Quality Press, [2019] | Includes bibliographical  references and index. Identifiers: LCCN 2019003748 | ISBN 9780873899871 (hardcover : alk. paper) Subjects: | MESH: Pharmaceutical Preparations—standards | Computer Security—  standards | Equipment and Supplies—standards | Quality Control | Drug Industry—  standards | Data Accuracy | United States Classification: LCC RS122.2 | NLM QV 771 | DDC 615.10285—dc23 LC record available  at https://lccn.loc.gov/2019003748

No part of this book may be reproduced in any form or by any means, electronic,  mechanical, photocopying, recording, or otherwise, without the prior written permission  of the publisher.

Publisher: Seiche Sanders Sr. Creative Services Specialist: Randy L. Benson

ASQ Mission: The American Society for Quality advances individual, organizational, and community excellence worldwide through learning, quality improvement, and knowledge exchange.

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To place orders or to request a free copy of the ASQ Quality Press Publications Catalog, visit our website at http://www.asq.org/quality-press.

 Printed on acid-free paper.

This book is dedicated to my parents.

In loving memory of my mother, Josefa, who is no longer with us but whose love and guidance are such a big part of me.

And to my father, Ginés, for your endurance and perseverance.

The work ethics and strength both of you taught me are my guide today.

TableofContents

List of Tables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xiii Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xv Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xvii Chapter 1 Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1 1.1 Good Data Management . . . . . . . . . . . . . . . . . . . . . . . . . . .1 1.2 Data Integrity and Why It Is So Important. . . . . . . . . . . . .5 1.3 Key Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 1.4 Good Documentation Practices: ALCOA and ALCOA+. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 1.5 Applicability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13 1.6 Quality Risk Management and Data Integrity . . . . . . . . .14 1.7 Data Quality and Data Integrity . . . . . . . . . . . . . . . . . . . .17 Chapter 2Integrity and Good Documentation Data Practices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 2.1 Type of Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19 2.2 Design of Record-keeping Methodologies and Systems: Creating the “Right Environment” . . . . . . . . . . .21 2.3 Procedure for Good Documentation Practices/ Data Integrity in Paper. . . . . . . . . . . . . . . . . . . . . . . . . . . .22 2.3.1 Generation of documents and records . . . . . . . . . .23 2.3.2 Distribution and control of documents and records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 2.3.3 Use and control of records within production areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .26 2.3.4 Filling out records. . . . . . . . . . . . . . . . . . . . . . . . . .26 2.3.5 Making corrections on records. . . . . . . . . . . . . . . .27 2.3.6 Verification of records . . . . . . . . . . . . . . . . . . . . . .29 2.3.7 Maintaining records . . . . . . . . . . . . . . . . . . . . . . . .31

vii

viii - Tabef oneont

2.3.8 Direct printouts from electronic systems . . . . . . . .32 2.3.9 True copies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33 2.3.10 Document retention. . . . . . . . . . . . . . . . . . . . . . . .35 2.3.11 Disposal of original records . . . . . . . . . . . . . . . . .36 Chapter 3Expectations and Examples  ALCOA: . . . ..37 3.1 Attributable . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .37 3.2 Legible, Traceable, and Permanent. . . . . . . . . . . . . . . . . 40 3.3 Contemporaneous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 3.4 Original . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .46 3.4.1 Retention of original records or true copies . . . . . .51 3.5 Accurate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .57 Chapter 4Expectations Regulatory . . . . . . . . . . . . . . . . . . . .59 4.1 Historical Perspective . . . . . . . . . . . . . . . . . . . . . . . . . . . .59 4.2 U.S. FDA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .61 4.2.1 FDA’s guidance for industry: “Data Integrity and Compliance with cGMP—Questions and Answer” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .66 4.2.2 FDASIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .68 4.2.3 Preapproval inspections . . . . . . . . . . . . . . . . . . . . .69 4.3 EU EMA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .72 4.4 UK MHRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .76 4.5 PIC/S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77 4.6 WHO. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81 4.7 ISO 13485:2016 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .81 Chapter 5Enforcement Regulatory . . . . . . . . . . . . . . . . . . .83 5.1 Consequences of Lack of Data Integrity: Regulatory Impact . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .83 5.2 FDA Debarment list . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 5.3 FDA Clinical Investigators: Disqualification Proceedings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91 5.4 FDA Enforcement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .91 5.5 Non-U.S. Enforcement . . . . . . . . . . . . . . . . . . . . . . . . . . .92 Chapter 6Life Cycle Data . . . . . . . . . . . . . . . . . . . . . . . . . . . .93 6.1 Data Collection and Recording. . . . . . . . . . . . . . . . . . . . .94 6.2 Data Transfer and Migration . . . . . . . . . . . . . . . . . . . . . .95 6.3 Data Processing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .96 6.4 Data Review, Reporting, and Approval . . . . . . . . . . . . . .97 6.5 Data Retention, Archiving, and Retrieval . . . . . . . . . . .100

- Tabef oneontix

Chapter 7Data Integrity into the Quality Integrating System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103 7.1 Quality System of Regulated Products . . . . . . . . . . . . . .103 7.2 Handling of Paper Records: Logbooks and Blank Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .104 7.3 Use and Control of Movable Storage Devices . . . . . . . .106 7.4 Personnel Attendance Records . . . . . . . . . . . . . . . . . . . .108 7.5 Data Integrity in the Training Area . . . . . . . . . . . . . . . .108 7.6 Self-inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 7.7 Laboratory Records. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 7.7.1 Exclusion of data for decision making . . . . . . . . . 113 7.7.2 Review of laboratory records . . . . . . . . . . . . . . . . 115 7.7.3 System suitability . . . . . . . . . . . . . . . . . . . . . . . . . 115 7.8 Production Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117 7.8.1 Documentation and verification of activities . . . . 118 7.8.2 Equipment alarms . . . . . . . . . . . . . . . . . . . . . . . . . 119 Chapter 8 Clinical Data Integrity. . . . . . . . . . . . . . . . . . . . .121 8.1 ICH E6(R2) Good Clinical Practice Guidance . . . . . . .121 8.1.1 GCP definitions. . . . . . . . . . . . . . . . . . . . . . . . . . .122 8.2 Institutional Review Board/Independent Ethics Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124 8.3 Investigator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .124 8.4 Sponsor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .125 8.5 Clinical Trial Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . 131 8.6 Investigator Brochure . . . . . . . . . . . . . . . . . . . . . . . . . . .132 Chapter 9Data Integrity Problems Preventing . . . . . . . . . .133 9.1 Commitment from All: Creating the Right Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .133 9.2 Quality Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .134 9.2.1 Code of ethics . . . . . . . . . . . . . . . . . . . . . . . . . . . .136 9.3 Modernizing the Quality Management System . . . . . . .137 9.4 Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .138 9.5 Data Integrity Issues and Human Error . . . . . . . . . . . . .138 Chapter 1Governance and Data Integrity0 Data Audit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .141 10.1 What Is Data Governance? . . . . . . . . . . . . . . . . . . . . . . 141 10.2 Data Governance System Review . . . . . . . . . . . . . . . . . 142 10.3 Good Documentation Practices and Data Integrity Self-inspection and Supplier Audits. . . . . . . . . . . . . . . . .144