Introduction to this course: 

This course covers the essential regulatory requirements for achieving 21 CFR Part 11 compliance. Learn the distinctions between open and closed systems, and the benefits of electronic records and electronic signatures. 

Who should attend: 

This course is for QC, QA, and manufacturing professionals in life sciences, as well as organizations adopting digital tools, automated processes, and maintaining FDA compliance for electronic records and signatures.

Learning outcomes: 

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

• Define the key 21 CFR Part 11 requirements, understanding their importance in electronic records and signature compliance.

• Describe the differences between open and closed systems, comprehending the regulatory implications and benefits of each system type.

• Identify the components and controls necessary for implementing electronic signatures, ensuring compliance with FDA guidelines.

What will I gain: 

In this course, participants will gain in-depth knowledge of 21 CFR Part 11 compliance, learn to distinguish between open and closed systems, effectively implement electronic signature controls, and develop confidence in managing digital tools and automated processes.

Prerequisites: 

Prerequisites include basic knowledge of electronic records and digital systems used in the life sciences.

Additional information: 

Course duration: 00:28:46 

Course code/version (effective date): L-23/v1.0 (03/08/2023)