21 CFR Part 11 is not new, and it has always been problematic for life sciences companies. To comply with those rules and regulations, you must be able to show incontrovertible proof that you are and have been following the mandates. There’s good news – the allowance of digital signatures and electronic records makes things at least somewhat easier. Of course, as with most federal regulations, the devil is in the details. That’s why we decided to look into what makes it into your 21 CFR Part 11 compliance checklist.

The bad news is that, even with a modern learning management system and other technology in place, it can still be challenging to ensure you’re doing things the right way. Our 21 CFR Part 11 compliance checklist will help. Note that this checklist is usable with multiple different types of systems, including choosing/implementing a learning management system. You can download the whitepaper “How to Prepare for a 21 CFR Part 11 FDA Inspection“.

Your 21 CFR Part 11 Compliance Checklist


Audit Trails

Electronic Records/Copies

Retaining Records

The information above is a rough guide to ensuring compliance with 21 CFR Part 11. However, if these are uncharted waters, it’s highly recommended that you work with an experienced partner. At eLeaP, we have years of experience developing Part 11 compliant LMS software and help ensure that your data is safe and secure in the cloud.

How Does an LMS Fit In?

The 21 CFR Part 11 compliance checklist above applies to all digital systems your organization uses where data might be compromised or that might allow an attacker/malicious software to access other parts of the system. Your LMS contains a wide range of sensitive information about your employees, certification information, career data, and much more. It is also connected directly to your HR software and likely dovetails with other software used daily within your business, whether you’re in pharmaceutical development, medical R&D, or hospital management. Given that, it’s critical that you have the right LMS in place and that it complies with the FDA’s requirements.

How Does an LMS Help?

Now that we’ve explored the 21 CFR Part 11 compliance checklist, we need to address a few questions, particularly as they relate to your company’s LMS. At eLeaP, we take data protection and authorized access very seriously. We’ve built our LMS from the ground up to ensure that it is completely in line with the FDA’s requirements and mandates. You don’t want to wait to receive a Form 483.

Our system is cloud-based and completely secured using best-of-breed encryption. We also require that electronic signatures correspond with user data, including mandating that an e-signature is provided before awarding a completion status. Our system can be configured to require password authentication at periodic points, and we’ll log accounts out after periods of inactivity to safeguard against unauthorized access. Other features and benefits of our LMS include:

All of our features have been extensively tested to ensure operability and compliance with the FDA’s rules, as well. Ready to find out just how well our LMS can support your learners? Contact us today to schedule a custom consultation.