The Fundamentals of Data Integrity
Description:
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.
Curriculum for this course:
Welcome
| Course Introduction | 1 min 15 secs |
What is Data Integrity?
| The Importance of DI | 30 secs |
| Consequences of DI Failures | 33 secs |
| Regulatory Framework | 23 secs |
| What's the News? | 38 secs |
ALCOA+ Principles of DI
| ALCOA+ Continued | 7 secs |
| ALCOA++ | 20 secs |
| In the Headlines Again | 29 secs |
Journey of Life Science Data
| In the Lab | 29 secs |
| In the Clinical Trial | 31 secs |
| In Manufacturing | 29 secs |
| More News! | 40 secs |
| Ongoing Monitoring | 42 secs |
| A Transformational Device | 27 secs |
Conclusion
| Summary | 48 secs |
Test Your Knowledge
Revision History
| Minor Update: Updated assessment question to improve clarity of answer choices. updated images and media | V4.2 |
| Minor Update: Assessment updated to fix reporting functionality. | V4.1 |
| 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:
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General Info:
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CEU Credits: 0.1 -
Course code: ELM-221 -
Duration: 15 mins -
Skill Level: Basic -
Language: English, Spanish, Japanese, Chinese, German, Portuguese, Italian, French -
Final Exam: Yes -
Certificate of Completion: Yes -
version: V4.2 -
Effective Date: 23/02/2024
Reviews:
Take Data Integrity as an example. I love the material currently available for GMP people. I can assign it to my GMP people and it just saved me 200+ hours of development work – ROI met.
Good content that didn’t go on for hours and hours. Short snip-its help!
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Computer System Validation (CSV): Validation Testing – Part 2
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