CFR 21 Part 11
What is CFR 21 Part 11
In short 21 CFR Part 11 is an US regulation that ensures electronic records and electronic signatures are secure, reliable, and equivalent to paper records and handwritten signatures. It applies to software systems used in FDA-regulated environments—such as quality management, lab data, manufacturing, or clinical trials....
How can Extra Horizon help ?
Extra Horizon is foremost intended to be used as a cloud solution for connecting Medical Devices to the cloud, meaning you can build medical devices on top of our platform. This is different from a regulated management system that is intended to prove compliance to regulated bodies on HOW the Medical device is built and maintained.
Extra Horizon can help you comply in the two scenario's!
Compliance for your product
First it is important to know wether your product needs to be compliant to CFR 22 Part 11... As mentioned in the first section, the regulation applies to software systems used in FDA-regulated environments—such as quality management, lab data, manufacturing, or clinical trials....
To summarize, regulation exists to ensure Medical Device Manufacturers create a treaceable and reliant management system in which they build and maintain the medical devices. This to ensure that regulatory bodies have control and insight when things go wrong.
Medical Devices products therefore DON'T need to comply with CFR 21 Part 11 as they are a result of the management system that needs to be CFR 21 Part 11 compliant.
When DOES CFR 21 Part 11 apply to my product?
In short, it would only apply when you or your customers need/want it to...
For example when you are building a product where its intended to be used in clinical trials and you want to add features that eases your customers life to comply with CFR 21 Part 11. For example you could implement features to sign and store records and remove your customer from the need to export, sign and store official records in another system.
Extra Horizon by itself is not CFR 21 Part 11 compliant, however our cloud services act as the perfect basis to make the necessary configurations to make a product that can support CFR 21 Part 11 compliance.
Compliance with Extra Horzion as a supplier
Customers of Extra Horizon that want to put their product on the US market need to achieve FDA certification and show CFR 21 Part 11 compliance of their management system.
Extra Horizon acts as a Medical Device Supplier for Medical Device Manufacturers. This means that as a medical device manufacturer you offload the cloud part of your medical product to us.
For this reason Extra Horizon has implemented a compliant management system itself and has achieved certification to ISO113485. Every official record that is shared with our customers to show compliance of how we operate your Extra Horizon clusters will be digitally signed by us and in compliance with CFR 21 Part 11 - This way you can guarantee compliance to your regulatory body for the systems our outsource.
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