CFR Part 11 Testing
Stop Guessing about LMS Compliance with 21 CFR Part 11
Is your life science business’s learning management system compliant with the FDA’s most recent rules regarding electronic records and signatures? It can be challenging to tell. However, it’s critical that you assess your LMS and make an informed decision. CFR Part 11 testing of systems and processes is required for full compliance with the FDA’s standard.
If yours is like many other organizations in the wider industry, you’re already laboring under a heavy regulatory burden in determining if your other electronic systems are up to par. Our goal here is to make things simpler for you. We’ll explore 21 CFR Part 11 testing to determine if your LMS is compliant with the most recent regulations and rules as set out by the FDA.
Should an LMS Be 21 CFR Part 11 Compliance: Testing the Idea of a Disconnect
Not sure if your LMS must comply with 21 CFR Part 11? The answer is, yes, it should. Any life science business must ensure that all of its electronic systems comply with the validation, auditing, electronic signature, and reporting mandates the FDA put in place, and that includes your learning management system. So, if your system is outdated and doesn’t provide the control and information access you need, it’s time to upgrade.
Can an LMS Help with Regulatory Compliance in Other Ways?
Yes, your learning management system can (and should) be a central part of preparing your workforce for 21 CFR Part 11 compliance. How might that work? Actually, it’s relatively easy to understand. With an LMS that allows you to author your own training content, it becomes simple to create lessons, modules, and even entire courses that speak directly to 21 CFR Part 11 rules and regulations as they apply to individual employee roles within the business.
It also becomes possible to create course content around proper information handling procedures, password hygiene, data security and protection, and even around company-wide processes, such as the procedure to follow if a mobile device is lost, how to deal with potential security breaches, and what to do in the case of a compromised electronic signature (username and password, usually).
How to Assess Compliance: 21 CFR Part 11 Testing tips for Your LMS
Given the importance of your learning management system, both to company-wide compliance with FDA rules, and for training employees and managing their training records, it’s vital that you have an LMS that’s up to the task. The only way to ensure that yours fits the bill is to do some assessing on your own. What should you assess? We’ll explore those things below:
- Is the LMS validated? If it was not validated prior to implementation, and the vendor does not offer any assurances of validation, you will need to go through the validation process yourself to make sure that the LMS is suited to your needs and “fit for use”.
- Does it offer electronic record inspection capabilities and the ability to protect your data? One part of 21 CFR Part 11 requires life science businesses to make training records available to FDA inspectors, which means the information must be shareable. Another critical consideration is the level of protection offered by the LMS. Is it possible for unauthorized users to access sensitive information?
- Are there clearly defined SOPs (standard operating procedures) in place that detail how the system is to be used? Do your employees understand those SOPs and follow them?
- What security precautions are in place? Does the LMS require every user to have a unique electronic signature? Does it regularly require learners to re-enter their password to move to new modules? Does it timeout after a period of inactivity and require the user to re-enter their credentials?
- Does your LMS create a robust audit trail that shows who made changes, when those changes were made, and why they were made?
- Does the LMS support versioning, allowing you to track which version of courses, modules, and tests users have completed, when they were completed, and when they might be out of date?
- Does the LMS automatically conduct device checks to ensure that all login attempts are from authorized devices only? Is there a procedure in place to handle unauthorized devices?
- Does the LMS support accountability and responsibility for each user regarding their actions within the system?
- Does the system provide you with strong controls for electronic signatures at all levels?
- Does the learning management system link electronic signatures to electronic records for accountability? Do those electronic signatures consist of multiple components, such as username/ID, password, change reason, timestamp, and date stamp?
- How does the LMS determine whether records are completed or incomplete? Does it automatically update administrators about incomplete or inaccurate records?
- How does the LMS handle things like user certification after course completion?
- Is original information kept intact even when the records have been modified by administrators so that all versions are clearly accessible and understandable?
Finding the LMS You Need
If you’re finding that the LMS used in your life science business doesn’t stack up, it’s critical that you make a change. As mentioned, training records are often the first stop on any FDA-led inspection, and if yours aren’t up to par, there could be significant consequences. Of course, finding a learning management system that complies with 21 CFR Part 11 regulations can be pretty challenging.
At eLeaP, we understand just how critical it is that you have a compliant LMS. Our system is fully validated and guaranteed to be compliant with 21 CFR mandates. It also offers the best of modern technology, mobile accessibility, and the ability to author your own content if you so desire. Contact us today to schedule your custom consultation.