Course Overview

Data integrity is often misunderstood with respect to its application within an organization. For example, differences between data security and 21 CFR Part 11 requirements, organizational scope, and how to assess organizational data integrity maturity. 

This course will describe the evolution of data integrity, take a deep dive into ALCOA+, explain the regulatory pieces and parts, give practical examples, and introduce data integrity tools for remediation and conducting an audit. 

By the end of this course, you will be able to:

  • Apply ALCOA+ principles to electronic and paper systems
  • Apply data integrity auditing principles
  • Have a deep understanding of the overall scope of data integrity
  • Formulate a remediation strategy for data integrity
  • Look for data integrity gaps

This course includes practical examples, section quizzes, and a final exam. A certificate of completion will be issued for final exams that score 80% or higher. You will be able to re-take the final exam if you do not achieve an 80%.  This course is available to stream as much as you'd like for 60 days!  

This course is recommended to Business Process/System owners, QA/QC management, Regulatory Management, CSV personnel, and IT project personnel.

Course Curriculum

  • 1


    • Data Integrity Principles and Application

  • 2

    Final Exam

    • Data Integrity Final Exam

  • 3

    Course Feedback

    • Course Feedback Survey

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