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Book Cover
E-book
Author López, Orlando, author.

Title Ensuring the integrity of electronic health records : the best practices for e-records compliance / Orlando López
Published Boca Raton, Florida ; Milton, Abingdon, Oxon : Routledge, an imprint of the Taylor & Francis Goup, 2021
©2021

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Description 1 online resource (xix, 319 pages) : illustrations
Contents Cover -- Half Title -- Title Page -- Copyright Page -- Dedication -- Table of Contents -- Foreword -- Preface -- Chapter 1. Introduction -- References -- Additional Readings -- Chapter 2. E-records Lifecycle Revisited -- Introduction -- E-records Lifecycle -- Records Identification Phase -- Records Standardization Phase -- Creation/Capture Phase -- Active Phase -- Inactive Phase -- Final Disposition Phase -- Regulatory Agencies' Expectations -- Summary -- References -- Additional Reading -- Chapter 3. Data and E-records Lifecycles -- A Comparison -- Introduction -- Data Lifecycle
Record Lifecycle -- Correlation of Data and E-records Lifecycles -- References -- Chapter 4. MHRA Guidance -- Revisited -- Brexit -- Introduction -- Data Governance -- Computer Systems Validation -- Requirements -- References -- Chapter 5. E-records Integrity Expectations of EU GMP Inspectors -- Introduction -- EMA E-records Integrity Technical Requirements -- EU E-records Integrity Guidelines -- Expectations of EU GMP Inspectors -- Conclusion -- References -- Chapter 6. Comparison of Health Authorities E-records Integrity Expectations -- Introduction -- Elements to Compare Guidance Documents
Key Elements of Each Guidance Document -- Differences between Guidance Documents -- Consistencies between Guidance Documents -- Summary -- References -- Chapter 7. Maxims of E-records Integrity -- Introduction -- Lifecycle -- A Measure of Validity -- Security -- References -- Chapter 8. Vulnerabilities of E-records -- What Is Record Vulnerability? -- Protection and Security of Electronic Records -- Threats that Can Impact E-records -- Regulated Users -- Malware and Phishing Attempts -- Service Providers -- Unrestricted Access to Computers -- Inadequate Disposal of Old Hardware
E-records Transfers -- E-records Storage -- Assessment of E-record Vulnerability, Risks, and Implementation of Control Measures -- Case Study -- Regulatory Agencies Expectations -- Summary -- References -- Chapter 9. CGMP E-records Risk Management -- Introduction -- Risk Management -- Regulatory Agencies Expectations -- References -- Additional Reading -- Chapter 10. CGMP E-records Risk Assessments -- Introduction -- How Can E-records Risk Be Assessed? -- Risk Assessment -- References -- Additional Reading -- Chapter 11. Security Service -- Introduction -- Computer Access -- Password Policy
Audit Trails -- Regulatory Agencies' Expectations -- References -- Chapter 12. Defining and Managing Manufacturing Data -- Introduction -- Data Lifecycle -- Medicine Manufacturing Operations -- Identification of CGMP Record -- Exchange of Data -- Storage of Records -- Protection of Data and E-records -- Transient Data -- Raw Data -- Retrieval of E-records -- Retention Time -- Disposition of E-records -- Summary -- References -- Chapter 13. Controls on Transient Data -- What Is Transient Data? -- Protection of Transient Data -- Regulatory Agencies' Expectations -- Summary -- References -- Chapter 14. Digital Date and Timestamps
Bibliography Includes bibliographical references and index
Notes "A Productivity Press book."
This title is designated as a historical resource after 2026
Description based on online resource; title from digital title page (viewed on November 10, 2021)
Subject Medical records -- Data processing.
Data integrity.
Data integrity.
Medical records -- Data processing.
Form Electronic book
ISBN 9781000222999
1000222993
9781000223033
1000223035