Fundamentals Series

The Fundamentals of Data Integrity

In this course, we will explore the foundations of data integrity. We first start with the importance of data integrity before learning the principles of ALCOA++. In the second half of the course, we follow the journey of data from the laboratory to the patient and learn about the data integrity priorities in each step.

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CEU Credits: 0.1
Course Code: ELM-221
Duration: 10 mins
Skill Level: Basic
Language: Chinese (Simplified), English, French (France), German, Italian, Japanese, Portuguese (Brazil), Spanish (Spain)
Final Exam: Yes
Certification: Yes
Version: V4.2
Effective Date: 02/23/2024

Curriculum for this course

Course Introduction
The Importance of DI
Consequences of DI Failures
Regulatory Framework
What's the News?
ALCOA+ Continued
ALCOA++
In the Headlines Again
In the Lab
In the Clinical Trial
In Manufacturing
More News!
ISO
Ongoing Monitoring
A Transformational Device
Summary

Test Your Knowledge

Minor Update: Updated assessment question to improve clarity of answer choices. updated images and media
V4.2
Major Update: This course has been redesigned. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well.
V4.0
Updated for content clarity
V3.0
Improve course content functionality
V2.2
Improve course content/clarity
V2.1

Author

peter.alcocer@veeva.com

Director of eLearning Compliance

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