Course Overview

When conducting a laboratory informatics computer system validation in a regulated environment, it can be easy to get lost in all acronyms and terminology, and struggle with where to get started.

This course will walk you through some of the validation jargon and provide instruction on how to begin with a documented risk assessment for your system. A well-documented risk assessment will help you set the stage for a risk-based, best practice approach to computer system validation.

You will learn: 

  • Key aspects and benefits of a documented functional risk assessment
  • How to perform a risk assessment
  • Risk priorities and ratings
  • Remediation strategies


This course includes a risk assessment worksheet assignment, quizzes, and a final exam. All passing grades of 80% or better will receive a certificate of completion. You will be able to retake the quiz until you pass. This course is available to stream as much as you'd like for 60 days! 

Course Curriculum

  • 1

    Course

    • Creating a Lab Informatics Risk Assessment

  • 2

    Final Exam

    • Risk Assessment Final Exam

  • 3

    Course Feedback

    • Course Feedback Survey

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