Life science companies are required to adhere to FDA’s 21 CFR Part 11 when it comes to digital record storage and access. These rules were handed down as part of the FDA’s strategy for reducing the risk of data breaches and information exposure. However, many companies struggle to understand how the rules apply to them and what steps they need to take.
One of the most important considerations, given the dramatic rise in the need for accurate corporate and professional training, is to ensure that your learning management system is 21 CFR Part 11 compliant. That can be a tall order, particularly for organizations struggling to ensure compliance in other vital areas.
At eLeaP, we’re proud to say that our LMS offering is a validated option in compliance with Part 11. What does that mean, though? How does our learning management system comply with the FDA’s 21 CFR Part 11 mandates?
Tags: 21 CFR Part 11 • Development • Human Resources • learning • learning and development • learning management system • LMS • microlearning • training • training and learning