Ensuring the Integrity of Electronic Health Records : The Best Practices for E-records Compliance book cover
1st Edition

Ensuring the Integrity of Electronic Health Records
The Best Practices for E-records Compliance

ISBN 9780367616038
Published December 22, 2020 by Productivity Press
340 Pages 5 B/W Illustrations

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Book Description

Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient.

This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.

Table of Contents

1 Introduction

2 E-records Lifecycle Revisited

3 Data and E-records Lifecycles – A Comparison

4 MHRA Guidance – Revisited

5 E-records Integrity Expectations of EU GMP Inspectors

6 Comparison of Health Authorities E-records

Integrity Expectations

7 Maxims of E-records Integrity

8 Vulnerabilities of E-records

9 CGMP E-records Risk Management

10 CGMP E-records Risk Assessments

11 Security Service

12 Defining and Managing Manufacturing Data

13 Controls on Transient Data

14 Digital Date and Timestamps

15 E-records Migration and Its Integrity

16 Ensuring E-records Integrity of Cloud Service


17 E-records Integrity in Hybrid Systems

18 Technologies Supporting E-records Integrity

19 Integration Between Computer Systems and

E-records Lifecycles

20 Miscellaneous E-records Integrity Issues

21 E-records Remediation Project Revisited – Medicine


22 Designing E-records Integrity into your Practices

23 Introduction to Data Quality

24 Summary

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Orlando Lopez has significant understanding and experience with worldwide regulatory authorities regarding CSV, e-records integrity, and related requirements/guidelines related to Production Manufacturing Systems, IT Systems, Analytics, and Business Intelligence. He has knowledge and experience in the development of governance and SLC deliverables. Wrote and deployed CSV methodology to computer infrastructure J&J worldwide. Several times he had re-engineered the computer validation methodology to regulated companies. Orlando Lopez has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications. He is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation and has written 25+ publications, including 9 computer compliance related books - amazon.com/author/orlandolopez/ Familiar with gap assessment, remediation planning and remediation execution activities.