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

  • Available for pre-order. Item will ship after November 24, 2020
ISBN 9780367616038
November 24, 2020 Forthcoming by Productivity Press
233 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 ensure safety to the patient. This book, relevant to production systems and quality control systems relevant to the manufacture of pharmaceuticals and medical device products and updates the practical information to enable the 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); 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


Chapter 1: Introduction

Chapter 2: E-Records Lifecycle

Chapter 3: Data and E-Records Lifecycles – A Correlation

Chapter 4: MHRA Guidance

Chapter 5: E-records Integrity Expectations of EUGMP Inspections

Chapter 6: Comparison of Health Authority E-records Expectations

Chapter 7: Maxims of E-records Integrity

Chapter 8: Vulnerability of E-records

Chapter 9: CGMP E-records Risk Assessments

Chapter 10: CGMP E-records Risk Management

Chapter 11: Security Service

Chapter 12: Defining and Managing Manufacturing Data

Chapter 13: Controls on Transient Data

Chapter 14: Digital Date and Stamp

Chapter 15: E-records and Migration and It’s Integrity

Chapter 16: Ensuring E-records Integrity of Cloud Service Providers

Chapter 17: E-records Integrity in Hybrid Systems

Chapter 18: Technologies Supporting E-records Integrity

Chapter 19: Integration Between Computer System and E-records Life Cycles

Chapter 20: E-records Integrity Issues • Audit Trails Review • Testing Audit Trails • Database Integrity • Verification and Testing – Retention of E-records • E-Records Integrity in Wireless Environments

Chapter 21: E-records Remediation Project (based on security with LAN, stand alone, legacy systems)

Chapter 22: Designing E-records Integrity into your Practices

Chapter 23: Data Quality

Chapter 24: Summary

Appendix I: Glossary of Terms

Appendix II: Abbreviations and Acronyms

Appendix III: References

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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.