Life science companies, including pharmaceutical companies, biotech firms, and medical device manufacturers, are required to comply with 21 CFR Part 11. It’s a wide-ranging, complex set of regulations that deal specifically with electronic records and electronic signatures. Because digital records and digital credentials are used in almost every area of your business today, those regulations impact just about everything, including product labeling.

21 CFR Part 11 Labeling

What Is the 21 CFR Part 11 Labeling Rule?

There is no 21 CFR Part 11 labeling rule – the rule itself is specific to electronic records and electronic signatures. It ties into labeling rules (21 CFR Part 201 and 21 CFR Part 211) that spell out exactly what companies that fall under FDA oversight must due in terms of labeling when it comes to pharmaceuticals and related products (such as sunscreen and OTC medications).

The basic gist here is that drug and medical device manufacturers, as well as all other companies under the FDA’s purview, preserve records of all the systems that are used in the production process. Obviously, that’s a significant number of systems, particularly when it comes to larger companies, and it can even include things like your barcode labeling system.

Labels with Electronic Signatures

The most direct connection between 21 CFR Part 11 and labeling rules is the mandate that labels be connected to an organization, manufacturer, or issuer through an electronic signature.

What is an electronic signature? 21 CFR Part 11 defines an electronic signature as, “(a) Electronic signatures that are not based upon biometrics shall:

(1) Employ at least two distinct identification components such as an identification code and password.

(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual.

(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components.

(2) Be used only by their genuine owners; and

(3) Be administered and executed to ensure that attempted use of an individual’s electronic signature by anyone other than its genuine owner requires the collaboration of two or more individuals.

(b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners.”

How Can an LMS Help?

While a learning management system cannot automatically ensure that you’re in compliance with the FDA’s labeling requirements, it can offer a wide range of benefits in terms of training and education.

How to Choose the Right LMS

With so many learning management systems on the market, how do you ensure that you’re choosing the right system for your medical device or pharmaceutical company? It can be pretty challenging, but the following list will help:

These are just a few of the questions you’ll need to answer when choosing your learning management system. The right choice will give you a valuable asset that will support positive outcomes for your employees for years to come while also helping you comply with federal regulations.

Contact eLeaP for more information about how our system can fit your needs and to schedule a custom consultation.