Why FDA Title 21 CFR Part 11 matters more than ever - Part 2
- Apr 5, 2018
- 2 min read
Updated: Mar 14, 2022
Title 21 CFR Part 11 has added much-needed clarity to how companies need to approach Electronic Record Electronic Signature (ERES) (to catch up on the history of the rule, click here.) Knowing what the rule entails is essential, but even more important is understanding how Part 11 impacts the day-to-day operation of a manufacturer.
Let’s take a look at the main business ramifications which Part 11 has on a manufacturer’s system(s):
Source: NetDimensions
The above image does a great job of showing the various impacts on a manufacturer. However, the solution(s) a manufacturer chooses must comply with the specifics of the regulation, including:
Controls for Closed Systems
Controls for Open Systems
Signature Manifestations
Signature/Record Linking
Electronic Signature Components and Controls
Controls for Identification Codes/Passwords
Furthermore, when a manufacturer submits regulated records to the FDA, it’s crucial that those records comply with Part 11, and be delivered to the FDA in a format they can receive. In order to achieve this, a manufacturer can use many different vendors to ensure compliance. In fact, Title 21 CFR Part 11 allows for a manufacturer to use any number of vendors, provided that they are all compliant. It’s important to note that no vendor can claim that their software products are “certified” Part 11 compliant, as the FDA doesn’t hand out this type of certification. Instead, a vendor can say that all of the technical controls for Title 21 CFR Part 11 compliance are built into their product. In the end, it’s up to the pharmaceutical manufacturer to ensure compliance with Part 11.
Although this post isn’t intended to be a comprehensive guide to Title 21 CFR Part 11 (for an in-depth view, click the link for a fantastic resource from Perficient), we hope it has provided greater insight into what compliance with the rules actually entails.
The next post in the series introduces new technology that helps satisfy the need to be compliant, and improve the bottom line.
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Part 11 is one of those regulations that looks technical at first, but it really comes down to trust in daily operations. Manufacturers need records, signatures, audit trails, and access controls that hold up when quality or compliance questions appear. I like how this topic connects rules to real workflow, because the best systems should help people do the right thing without slowing everything down. While organizing verification tools, I came across BeenVerified , which reminded me how much modern work depends on accurate digital records. Clear electronic signatures and reliable data trails can make compliance feel less stressful and more practical.
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