What is FDA 21 CFR Part 11?

In this month’s blog, we take a closer look at FDA 21 CFR Part 11 and what this regulation means to the user who wishes to monitor temperature sensitive products. After all, regulations such as these are an important element for any organisation engaged in research and/or manufacturing.

In simple terms, FDA 21 CFR Part 11 outlines how an organisation can use electronic records and signatures in place of paper-based documents so that it complies with FDA regulations. Let’s take a closer look at the details of this:

What do all these acronyms mean?

The FDA stands for the Food and Drug Administration, the federal agency concerned with public health. The number 21 is the section which governs Food and Drugs in the United States and the CFR stands for the Code of Federal Regulations. Part 11 refers to the criteria in which electronic records and signatures are considered secure.

Who has to comply with FDA 21 CFR Part 11?

Any organisation that makes either paper or electronic records compliant with the FDA will need to comply with 21 CFR Part 11. This can be a variety of different types of organisations, but it is most commonly seen in the pharmaceutical industry. Nevertheless, we also see other types of businesses who need to comply with 21 CFR Part 11. This can include, but is not limited to, medical device manufacturers and biotechnology companies.

Although the regulation is aimed at companies operating in the USA, it can also be applicable with other businesses from around the world, especially those engaged in the US market. Similarly, if you are releasing a product in the USA or working with an American company, you will need to comply with the FDA regulations.

FDA 21 CFR Part 11 requirements

FDA 21 CFR Part 11 is divided into three main sections:

General provisions

This section defines the scope and defines the terms within the regulation. In addition to this, it makes reference to the implementation of the regulation. You can read more about this here.

Electronic records

This section deals with how electronic records are controlled. It focuses on the identity of the user being verified. It outlines how organisations should inform the FDA if it intends to use electronic signatures as legally binding. More details on this can be found here.

Electronic signatures

In this section, the general requirements with regards to electronic signatures are outlined. This includes passwords and/or PIN codes that may be used for digital signatures. More information on this can be found here.

How Henderson Biomedical can help

Henderson Biomedical is able to offer general guidance on 21 CFR Part 11 with regards to temperature monitoring. However, it is strongly recommended that you consult the official FDA regulation for more specific details.

We are the UK distributor of the Eupry wireless temperature monitoring system. This system can be compliant to the FDA 21 CFR Part 11 and Eupry can add a module to your online portal, giving you extra functionality that ensures compliance.

More information

In the first instance, you can contact our team on 020 8663 4610 or via email at info@henderson-biomedical.co.uk. Alternatively, Eupry have a section on their website which details how their system complies to FDA 21 CFR Part 11.

In addition to this, there is a white paper available from the Master Control website.