1st Edition

Planning Quality Project Management of (EMR/EHR) Software Products

By Richard Chamberlain Copyright 2018
138 Pages 2 B/W Illustrations
by Productivity Press

138 Pages 2 B/W Illustrations
by Productivity Press

138 Pages 2 B/W Illustrations
by Productivity Press

When hospitals began implementing their electronic medical records/electronic health records systems (EMR/HER) the pharmaceutical companies that were conducting clinical trials at those hospitals wanted to sue the date from those systems instead of having the hospitals enter the data in their EHR systems and also in the study data entry system. However, the FDA regulations would require that the... Read more

1 Introduction: The Basics

2 Quality Management

3 Managing Patient Information

4 Applying the Organization to Observation Processes

5 Applying Quality Management to Computers

6 The HIMSS-EHR Developer Code of Conduct

7 Developing Standard Operating Procedures (SOPs)

8 Compliance

9 Conducting Audits

10 Risk Management

11 Risk Analysis

12 If All Else Fails

Appendix A Deming-Key Principles

Appendix B FDASIA Health IT Report

Appendix C Sample SOPS

Biography

Dick Chamberlain has a PhD in Statistics and has consulted with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of Computer Systems Validation, computerized project scheduling, strategic planning, quality management, and qualification.

He has assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management, Information Quality, and Compliance to Regulations.