1st Edition
Ensuring the Integrity of Electronic Health Records The Best Practices for E-records Compliance
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
Biography
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.
