Achieving 21 CFR Part 11 compliance can be a daunting and exhausting task, filled with many uncertainties and grey areas. But before we dive into the nitty-gritty, what is the 21 CFR part 11 regulation, how can Agaram’s CFR gateway help, and why is it important to comply? We’ll answer all that and more momentarily.
The Food and Drug Administration (FDA) is a US government subsidiary that provides oversight in the following areas to safeguard public health:
- Medicinal products
- Food products
- Medical devices, among others.
The 21 CFR Part 11 is a regulation passed by the US FDA concerning the management & protection of electronic records & signatures.
What exact requirements do industries need to meet for 21 CFR Part 11 compliance?
A compliant lab workflow, in the eyes of the FDA and its 21 CFR Part 11 regulation, is mandated to be able to:
- Record and keep tabs on all conditions under which electronic records have been generated, archived, retrieved or modified.
- Ability to generate accurate trustable & accurate copies of all electronic records for inspection, review & approval.
- Use of Electronic signatures for electronic records for compliance with federal food & drug safety regulations.
- Computer-generated Audit trails with full date & time stamps to record all operational changes made to electronic records.
How Agaram’s CFR gateway can help laboratories achieve 21 CFR Part 11 compliance?
First things first: what exactly is Agaram’s CFR gateway? Simply put, it’s the first-of-its-kind module that serves as the middleman, if you will, for Windows applications. Workflows can install it on their Windows OS environment, and in turn use the tool to control application access, configurations, and permissions, among other features.
That said, here are a couple of ways that the CFR gateway keeps you on the right side of the FDA and other compliance regulators:
- Safeguarding data quality
One of the most important requirements is to ensure the integrity of any data you record, i.e., keeping it safe from editing and deletion at will. This becomes a huge concern, especially with large collaborative teams that share a single repository or database.
Thanks to the CFR gateway by Agaram, your data integrity is assured at all times. Actual data files on your local PCs are incorruptible because system users don’t have direct access to these files or folders so they are unable to perform the following operations:
Instead, application modified files are versioned and diverted to a server, which means no data can be lost through human intervention in the aforementioned ways.
- Restricting login and electronic record access
There were a total of 2,860 breach incidents involving healthcare data between 2010 and 2019, according to a healthcare study published in NIH. Out of all these cases, internal unauthorized disclosures accounted for 843, which is roughly about 29.48% of that figure. This goes to show just how real the threat is and the need to govern electronic data access better.
Unauthorized persons accessing electronic data in your workflow certainly goes against the 21 CFR part 11 compliance regulation and could land your laboratory in hot water. Agaram’s CFR gateway enables you (i.e. Administrator) to delegate permission only to certain users who are authorized to log in and use the system. What’s more, logged-in users can only view only those applications that you’ve permitted them to use.
- Ensuring accountability
In addition to regulation access, the CFR gateway goes one better by enabling you to get crucial details about your gateway users. Namely, you’ll be able to see:
- Who logged in/off
- And their date/time stamps
In a nutshell, you’ll be able to follow the complete log in/off trails and even trace specific operations to individual users. Your workflow will enjoy better accountability as a result, and this ticks yet another important compliance requirement off your checklist.
- Ability to run non-compliant software
For vendors, there isn’t a strong conviction to make their software solutions and instruments 21 CFR Part 11 compliant, because their regulated industry market share is quite small and inconsequential compared to the global market size they serve. It is for this reason that many software solutions and instruments don’t have the needed features to ensure compliance.
One Agaram CFR gateway feature that proves a life-saver in light of the above predicament is its ability to run and control access to non-compliant software. Via the gateway launcher, you can run non-compliant software without breaking a sweat and automatically keep track of all generated files.
Achieve 21 CFR Part 11 Compliance today
Beyond avoiding conflicts with industry regulators what else do you stand to gain by achieving compliance through Agaram’s CFR gateway? Well, operations of the computerized systems will tend to realize far fewer data-related errors which usually crop up due to human errors. This increased level of data integrity will also mean better privacy protection in addition to faster turnaround times when it comes to filtering, capturing, and analyzing data. You’ll also benefit from better process control with compliant systems. Ready to get started on your compliance journey? Schedule yourdemo today.