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?

We’ve built in multiple layers of compliance, combined with state-of-the-art safeguards designed to help ensure data security at all times. In this post, we’ll explore critical elements in our LMS’s compliance.

Access Controls

One of the most important elements in complying with the FDA’s 21 CFR Part 11 is controlling access to electronic records stored within a system. At eLeaP, we understand just how critical that is, and our LMS delivers robust protection in several different ways.

Unique IDs and Passwords

First, all users must have their own login and password. Users are not able to share login credentials or even have similarities between their credentials. This helps ensure that only authorized users have access to training records and sensitive data.

Electronic Signatures

Unique usernames and passwords are just part of the process here. The FDA requires that strong electronic signatures are used. These are just a combination of the username and password with another piece of information, usually the reason for a change in an electronic document. Our system helps ensure robust electronic signatures, complying with FDA mandates for life science companies.

Unauthorized Access Protection

One of the simplest ways for bad actors to gain access to sensitive information stored within your learning management system is to force an unauthorized login. In this situation, an attacker will attempt to log in using partial credentials, guessing at username and password characters. If not stopped, it is entirely possible that even the strongest password/username combination will be guessed in time, particularly if the attacker is using sophisticated software.

At eLeaP, we prevent that by disallowing multiple incorrect login attempts. Users are allowed only a few attempts (we’ve all mistyped a password before), and then they are required to validate their account log in attempt. Additional ip-based blocking can be deployed.

Custom Permissions

At eLeaP, we understand that change happens and we built in the capabilities to handle that through our custom permissions feature. Administrators and decision-makers can use this feature to:

• Add new users to the system
• Set permissions for access to specific areas of the LMS
• Block/deny access to specific areas of the LMS
• Revoke previously given permission to access sensitive areas
• Remove users from the system

Auditing and Audit Trails

21 CFR Part 11 requires that all electronic systems have “audit trails”. At eLeaP, we realized just how important it is that our clients have transparency and traceability, which is what auditing and audit trails are all about, after all. We designed our LMS from the ground up with complete traceability and accountability in mind. This ensures:

• All changes to electronic records are mapped to the username/electronic signature making the changes.
• All changes are time and date stamped for future reference.
• All changes must include a reason for the change.

Detailed Reporting

The FDA requires that all the information specified in 21 CFR Part 11 is accessible and shareable. It must be able to be printed, as well as shared in digital (electronic) formats, such as PDF and XML. At eLeaP, we provide you with robust reporting capabilities to ensure not only compliance with the FDA’s rules but also that you can access the information you need to make informed decisions.

In the end, an LMS is about supporting your learners and helping them move forward. Our reporting options allow you to track learner progress, see where they’re spending the most time and possibly struggling, see where they excel, and more. It’s all about providing you with access to the information necessary to make informed decisions while protecting data and ensuring accountability and transparency.

Is FDA Compliance the Only Thing Required?

It’s tempting to think that ensuring your LMS and other electronic systems comply with the FDA’s 21 CFR Part 11, but there’s more to it than that. Ultimately, protecting sensitive data requires more than just digital safeguards. It will also require organization-wide training.

Some of the things that life science companies must train their teams for include the following:

• Credential Safety: Never sharing credentials with others, and never writing usernames/passwords down where they can be seen or stolen.
• Password Strength: Passwords must be strong to defeat attackers. Employees should be trained to create the strongest passwords possible.
• Never Reuse Passwords: Many people use the same password for multiple systems to help them remember it. However, this dramatically increases the risk of a data breach because if an attacker cracks one password, they have access to every system where the employee used the same password.
• Password Hygiene: Passwords are like clothing – they need to be changed periodically. Regularly changing passwords helps ensure that there is less risk of an attacker cracking one and gaining access to sensitive information.

The Protection You Need, the Functionality You Deserve

At eLeaP, we’re proud of our 21 CFR Part 11 compliant LMS. However, it goes so much deeper than just complying with government mandates. Our system is designed to support your learners at each step along their path, enable better decision making, allow you to track learner progress, and, ultimately, improve organization-wide success.

See our 21 CFR Part 11 resources page for additional information.