What Is 21 CFR 11?

What Is 21 CFR 11? Medium Image

How much time do you spend each day hunting down signatures? Or do you get to use a digital system to endorse documents? If you get to record, verify, and store data digitally, you can thank 21 CFR 11.


21 CFR 11 refers to Code of Federal Regulations Title 21 Part 11: the Food and Drug Administration’s guidance on maintaining data integrity in digital applications. It requires certain attributes from digital systems that are used to gather signatures and verify data. This requirements improve your data integrity.


In a cleanroom, your data integrity is your lifeline. Without it, your cleanrom cannot be classified, you cannot trust your data, your application or product is at risk, and so much more.


So what exactly is data integrity, why does it matter, and how does 21 CFR 11 impact this?


Data Integrity 101


According to the Food and Drug Administration (FDA), “data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA).” Essentially, this is how much you can trust the data generated in your cleanroom.


Data integrity is, in general, how reliable and trustworthy your data is. Can you rely on it? Can you trace it back to its source? Can you back it up? How did you get your data? While it might feel like a simple process, it is actually quite elaborate. There are ways to help you ensure that you are properly maintaining your data integrity, but we’ll get to that.


The data we will be referring to today is primarily particle counter data in a cleanroom; however, you might generate any amount of data from different sources in your cleanroom depending on its application. The data from your particle counter is particularly important, though, as it is required for cleanroom verification and product safety.


Why Data Integrity Matters


Your data integrity is the foundation of your cleanroom. If your data is brought into question, your entire operation must be reconsidered.


Think for a moment about what happens if you discover that a piece of critical data you received from your particle counter a week ago was not verifiable. You suddenly cannot trust any data you have. What went wrong in the process? Were products contaminated?


Your next step might be a recall and a negative impact on your brand’s reputation.


On the other hand, if you had properly verified, traced, and attributed your data, you would not be in this situation. You could rest easy knowing that you can rely on your data.


Defining 21 CFR 11


In order to help pharmaceutical companies maintain data integrity while utilizing modern technology, the FDA developed 21 CFR 11. This measure was published in 1996, although Part 11 was released over the following year to adjust to new technology. 


21 CFR 11 was realized when it became apparent that the pharmaceutical industry was being left in the dust. While other organizations made incredible, rapid, ground-breaking discoveries, the pharmaceutical industry was bogged down by time lost chasing real world signatures and collating paper documents.


This measure helps pharmaceutical companies meet market demands and bring new products to the market using digital tools while maintaining high levels of authentication.


Essentially, 21 CFR 11 refers to how electronic signatures are handled, stored, and verified for documents that need to be traceable and submitted to the FDA. While computerized systems are supported, they must be validated. It also requires a verifiable audit trail, copies of record, and record retention.


In short, it requires that all information verified through these systems follows the ALCOA concept.

ALCOA Concept

In the 1990s, the FDA introduced the ALCOA concept. ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. In the following years, the concept was expanded onto and rebranded ALCOA+, which includes Complete, Consistent, Enduring, and Available.
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The ALCOA and ALCOA+ concepts have been proven to be effective forms of maintaining data integrity. They offer sound guidelines for systems and organizations to follow to ensure that the data meets appropriate GMP and 21 CFR 11 guidelines.


If your cleanroom application is subject to audit by the FDA, it needs to follow ALCOA guidelines. But even if you are not subject to an FDA audit, following ALCOA is still best practice.


Unless your cleanroom is just a hobby cleanroom, you will be subject to regulations from one entity or another. Providing attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available data will always be a critical component of your cleanroom.


How To Find Out More About 21 CFR 11


21 CFR 11 is not a super simple topic. Anytime we talk about federal regulations, the topic can get complex and very legal. It can definitely be confusing!


While this article provided a brief introduction to 21 CFR 11, we recognize the extent of the guidance goes much deeper than what was presented here.


No worries, though, because every month we host a free webinar to break down these complex topics in a simple to understand format. We’re also available to answer questions. In July of 2022, we are hosting a webinar specifically for 21 CFR 11. If you would like to claim a seat, click here.


If you are reading this at a later date, you can click here to watch a replay.

Jun 30, 2022