top of page

Why FDA Title 21 CFR Part 11 matters more than ever - Part 2

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.


bottom of page