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Articles QMS Software

May 31, 2023

How We Keep Your Formwork Data Safe

Dr. Oliver Eidel

Many companies ask us how we keep their data in Formwork safe. That’s a very reasonable question because you’re entrusting us with very important data which essentially decides whether you pass your audits or not!

So, here’s a description how we keep your data safe.

First off, we don’t use US-based cloud providers. While everyone and their dog has their own unique opinion on whether using US cloud providers is okay for EU companies and whether US authorities can really access your data, we just opted to not be part of that discussion. Instead, we run Formwork on Scalingo, a French hosting company which, by the way, is profitable and not venture capital - funded (cool!).

The data in our SQL database is mirrored across three servers and backed up daily.

For object storage (i.e., your attachments and images), we use Scaleway. Data there is mirrored across three locations.

But there’s more. We use yet another European provider, OVHcloud, to store daily backups of both the SQL database and the objects. These data centers are located in Germany, so even if a meteorite hits France and destroys all data centers there, your data will not be lost.

Is this safe? Yes. We’re literally storing everything in a redundant way, mirroing across servers and across providers (even across countries!). Hardly anyone does that, but then again, hardly anyone builds eQMS systems which handle this sort of critical data.

What else can you do? Glad you asked - you can export your Formwork data any time. This is not only good if you ever want to move to another eQMS provider; I’d also encourage you to do so regularly just so you keep a backup of your eQMS data somewhere in your infrastructure, even if it’s only your local laptop!

This will guard against the worst-case scenarios of your internet connection going down, or all data centers in France and Germany burning down at the same time, or thermonuclear war. Let’s hope that none of those things happen, and even if they do, that they don’t happen while you’re sitting in an audit with a notified body. Still, even then, you can whip out your handy batch export and continue the audit with the exported PDFs and spreadsheets.

That’s it. Let me know if you have any further questions!

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On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you're still lost and have further questions, reach out any time!

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No QMS on this planet will save you from creating crappy software.