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

ISBN-13: 9780367616052 / Angielski / Twarda / 2020 / 320 str.

Orlando Lopez

Opis

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.

Spis treści

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 Providers 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 Manufacturing 22 Designing E-records Integrity into your Practices 23 Introduction to Data Quality 24 Summary