Articles

Updated December 2, 2022

QMS Software: All You Need to Know

Dr. Oliver Eidel

This post is a summary of all our content on Quality Managemenet System (QMS) software. My assumption here is that you are completely clueless and have no idea what QMS software is - but no worries, we’ve got you covered! After reading all articles below, you’ll have a solid idea of what QMS software is and whether you need it.

Contrary to articles on other websites, our posts are written in simple English, for normal humans (and not regulatory people, although those are often also humans).

What Is QMS Software? And Do You Need It?

Let’s get started by looking at what QMS software is and whether you need it. The TLDR here is that it can help you optimize your compliance documentation if your company is operating in a regulated industry (e.g. medical devices), but not all companies need it. You may be able to roll your own solution in e.g. GDrive.

Read the article here: What Is QMS Software, and Do You Need It?

Which QMS Software Is Out There?

There’s quite a lot of QMS software out there. Those solutions are often difficult to compare because their vendors don’t offer demo accounts or only shady demo calls in which they walk you through some shiny slides. We’ve done the work for you, tried out different solutions and attempted to compare them.

Note: We do focus on medical device compliance because that’s the area our company operates in :)

Read the article here: QMS Software for Medical Devices (ISO 13485): The Ultimate Comparison

What About Enterprise QMS Software?

Most QMS software vendors cater towards enterprise companies. For most startups, this is a very weird experience because software can’t simply be purchased from a website, and instead you have to talk to a salesperson who typically has absolutely no deep understanding of the technical details of their software.

So the question really comes whether buying enterprise QMS software makes sense for startups - by the way, the short answer is no.

Regardless, we wrote an entire article about it. Read it here: Enterprise QMS Software: Don’t Waste Your Money

QMS Software Choices

Can You Use Google Drive As Your QMS Software?

Yes, you can! You can set up a compliant QMS in Google Drive. While it’s not perfect, it may be a reasonable choice if you’re a small startup on a budget. Have a look at our post on how to set it up.

Can You Use GitHub / GitLab For Your QMS?

If you’re a software developer, you’ve probably wondered whether you can simply store your regulatory documentation in git. I mean, git is kind of the de-facto standard version control system, so it seems up to the task. The short answer is that yes, you can set up a compliant QMS in git (specifically, GitHub / GitLab), but it’s a terrible idea.

First, have a look here how to set it up: Setting Up A QMS In GitHub / GitLab

Then, understand why it’s a terrible idea and you should never do it: We No Longer Recommend GitHub / GitLab as QMS Software

What About Integrating With Jira?

For some mysterious reason, companies are still using Jira and Confluence. They often wonder whether QMS software might integrate with those systems, leading to a magic way in which they could automate all their regulatory documentation.

There’s unfortunately no magic way to automate your regulatory documentation, and assuming that a Jira integration for QMS software would solve any of this is wrong. Still it, it’s a topic worth discussing.

Here’s our article: QMS Software And Jira / GitHub / GitLab Integrations: Don’t Make a Mistake!


And finally, here’s a list of all our QMS software articles.

All QMS Software Articles

Setting Up a Quality Management System (QMS) in Google Drive
We No Longer Recommend GitHub / GitLab as QMS Software
Enterprise QMS Software: Don't Waste Your Money
What Is QMS Software, and Do You Need It?
Setting Up a Quality Management System (QMS) in GitHub / GitLab
QMS Software for Medical Devices (ISO 13485): The Ultimate Comparison

Questions Other Companies Ask Us About QMS Software

QMS Software And Jira / GitHub / GitLab Integrations: Don't Make a Mistake!

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 software which helps you create your documentation yourself, for only 149€ / month. No prior knowledge required. You should check it out.

Or, if you're looking for some human help, did you know that we also provide consulting, often guiding startups from start to finish in their medical device compliance?

And there's so much more: If you're looking for the best QMS software ever, look no further. We've built Formwork, and it's free!

Congratulations! You read this far.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I've helped 50+ companies with their medical device compliance. I mainly work as a regulatory consultant, but my goal is to make consulting unnecessary by publishing all of our articles and templates for free :)

If you're still lost and have further questions, just send me an email. Read more about me here.

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