Life science organizations face a wide range of challenges today. The industry is increasingly competitive, for instance. Changing consumer demand, evolving audience demographics, price sensitivity – these are just some of the issues your organization faces. The Code of Federal Regulation (CFR) called 21 CFR Part 11 is that dictates how life sciences organizations handle electronic records and electronic signatures. We will link to the full text of the standard below.

21 CFR Part 11 Full Text

You also must contend with increasing government regulation, such as 21 CFR Part 11, which deals with how your organization stores and accesses digital records, and the use of electronic signatures. Do those regulations apply to your learning management system? Absolutely, they do. However, the actual impact may not be quite what you expected. In this guide, we’ll take a look at what you should know.

What is 21 CFR Part 11?

21 CFR is a section of the Code of Federal Regulations. Part 11 specifically deals with:

According to the 21 CFR Part 11 full text and the subsequent clarifications and guidance offered by the FDA:

FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures):

Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. We recommend that you document this decision (e.g., in a Standard Operating Procedure (SOP), or specification document).

How Does the 21 CFR Part 11 Full Text Apply to Your Learning Management System?

There are several obvious ways that 21 CFR Part 11 applies to your organization’s learning management system. These include:

Does the FDA Really Care about Training Records?

Yes, the FDA can and will inspect your electronic training records. In fact, in many instances, training records are among the first inspected during a compliance audit. Therefore, it’s critical to choose an LMS that is built from the ground up with 21 CFL Part 11 in mind.

What Steps Must Be Taken?

The same steps need to be taken with your LMS as with any other electronic system your organization uses to record, store, or access digital records. These include:

eLeaP Can Help

For most life science organizations, building an in-house LMS from the ground up to comply with the 21 CFR Part 11 full text is a daunting task. At eLeaP, we designed our groundbreaking LMS to provide all the functionality demanded by the FDA’s regulations and to empower you and your learners while simplifying compliance and delivering the quality training your team needs.