Good Laboratory Practices (cGLP)

Laboratory Data Integrity

In today’s data-driven world, the integrity of laboratory data is paramount. Ensuring the reliability and trustworthiness of results is not just a regulatory requirement but a fundamental aspect of maintaining the highest standards of science, research, and healthcare. This course explores what data integrity means, potential consequences due to compromised data, and a practical example of ways to assure data is reliable and trustworthy.

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CEU Credits: 0.1

Course Code: ELM-102

Duration: 15 mins

Skill Level: Basic

Language: English

Final Exam: Yes

Certification: Yes

Version: V3.1

Effective Date: 09/22/2023

Curriculum for this course

Course Introduction

Overview

What You Will Learn

Welcome to the Lab

Data Integrity and Manipulation

Regulatory Reminder

Potential Consequences

Patient Consequences

Company Consequences

Staff Consequences

Electronic Records

Charlies Data "Solution"

Challenges of Electronic Records

Accessing Electronic Records

Audit Trails

Practical Application

Mobile Phase

Suitability Solutions

Sample Prep

Integration Peaks

The Case of Annie Dookhan

Conclusion

What We Covered

Test Your Knowledge

Revision History

v3.1 Minor update on 06/02/2025 Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.

v3.0 Major update on 11/08/2023 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. This course’s previous title was Laboratory Data Integrity and the Principles of ALCOA. As part of the redesign, this course’s new name is Laboratory Data Integrity.

v2.0 Course released on 03/14/2024