Ensuring the integrity of electronic health records [electronic resource] : The best practices for e-records compliance.

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.