21 CFR Part 11
What Should a Life Science Company Look for in a 21 CFR Part 11 Compliant Learning Management System?
Learning management systems (LMSs) offer powerful benefits for companies in the life sciences industry. They deliver the means to provide training to all employees, quickly, easily, and through a central platform. They offer ease of tracking and monitoring, and can even provide the opportunity to author your own content in some cases. However, not all learning management systems comply with federal law. For life sciences companies, it’s critical to find a 21 CFR Part 11 compliant LMS.
What is 21 CFR Part 11?
The 21 CFR Part 11 standard was adopted by the FDA in direct response to the increase in cybersecurity threats and data breaches. It deals specifically with electronic records and electronic signatures, and details what is expected of hospitals, pharmaceutical companies, doctor’s offices, and other life sciences firms in terms of protecting digital records and the use of electronic signatures.
What Role Does an LMS Play in Compliance with 21 CFR Part 11?
For organizations that maintain or compile data on individuals, the right LMS is essential for complying with the federal mandates outlined in 21 CFR Part 11. Choosing the right learning management system is critical, and will play a central role in how well secured electronic records are, how secure system logins are, and even whether unauthorized access attempts are noticed and logged.
Not sure how to choose the right LMS to ensure that you comply with 21 CFR Part 11? We’ll walk you through some of the must-have features and capabilities with the right learning management system below. You can also get a free 15-minute consult.
One of the first things to consider when choosing an LMS is whether or not it secures user data and prevents unauthorized access. The system should provide administrators with the ability to set access limits for users, ensuring that everyone has access to the information they need, but no more. Administrators should also be able to identify and then block suspicious users. Protecting user data is one of the core goals of 21 CFR Part 11.
Strong Login Protection
Another consideration when choosing an LMS for compliance with 21 CFR Part 11 is the level of login protection offered. Are usernames and passwords required to be completely unique? Does the system automatically prompt users to change their username and password regularly to ensure good hygiene? Some learning management systems that handle huge user loads may share the same login or have similar logins. It’s critical that every user has completely unique credentials and that they change their logins regularly. Learn more about 21 CFR Part 11 password policy.
Two Sets of Credentials
In the past, it wasn’t uncommon for systems to allow users to log in with just a password. However, a single set of credentials is not sufficient to prevent unauthorized access. Two sets of credentials, such as a username and a password, or even a password and something the user might have with them physically, such as an ID tag, can provide stronger authentication. Two-factor authentication – a standard username/password plus digital verification through a smartphone or other mobile device – can provide even more protection.
Tracking Unusual Activity
While technology has advanced a great deal, it has yet to reach the point that it can determine whether multiple login attempts are due to user error or if there is malicious activity occurring. Your LMS must be able to track unusual activity so that you can check for patterns in behavior, lock down individual accounts, and take other corrective action to ensure that the data within the system remains safe and protected.
Real-Time Progress Monitoring and Reporting
Your learners must make progress – biotech, pharmaceuticals, R&D, and other industries are fast-paced and it’s important that you’re able to approve new qualifications as quickly as possible. Make sure that your LMS provides you with real-time progress monitoring and reporting so that administrators can see at a glance where employees are in their courses in real-time. Your LMS should also include an e-Signature-required setting, which provides administrator control over qualification approval and helps ensure compliance with 21 CFR Part 11.
Course Update Control
New discoveries, advancements in research and development, new materials – all of these lead to the need for updates to your learning management system content. Not just that, but there will be system-wide updates and patches that address functionality, flow, security, and other considerations within the LMS itself. To comply with 24 CFR Part 11, you must have strong version control so that course updates and system updates can be communicated to learners.
A lot of attention is paid to authorization for logging in, but security threats can also be present if a user leaves their login unattended. Both cyberattacks and in-person threats can compromise data security in these instances. Make sure that the LMS you choose uses automatic timeouts. These will automatically log any user out after a specified period of inactivity, helping to reduce the chance that a user’s account could be hijacked.
Periodic Password Identification
Similar to automatic timeouts, make sure that the LMS you choose requires users to periodically reenter their passwords during a session. This helps eliminate the possibility that an account might be compromised and ensures identity during a learning session. You should be able to configure the interval between login and re-authorization through the system’s control panel for compliance with 21 CFR Part 11.
Making Your Decision
We’ve covered some of the most important considerations for life sciences companies searching for a new LMS that conforms to the mandates set out in 21 CFR Part 11. The right LMS will ensure that you’re in-line with federal requirements, but also ensure your learners have a seamless experience, and that your administrators have the tools they need to ensure a positive user outcome.