All You Need to Know About QMS Software

Dr. Oliver Eidel
Updated June 11, 2024

What the hell is QMS software, and do you need it? And how do you learn more about QMS software without falling asleep or being bombarded by sales calls from shady enterprise QMS vendors? Difficult questions indeed.

I’ll try to give you an overview over all your software options below. Note that this is somewhat of an overview article, so I’ll try to always give you a brief summary of each topic while adding links to other articles on our website which go into more detail.

After reading this, you’ll hopefully have a solid understanding of what QMS software is, you hopefully didn’t fall asleep, and you hopefully have understood enough so that you won’t make a mistake when choosing the right software.

Let’s get started!

New: The True Shadiness Of This Industry

We’ve seen a lot of customers choose different QMS software for their medical devices, and many of them ran into huge problems because the industry is really, really shady. I wrote up our main learnings here, so definitely read them if you’re looking this sort of software for your medical device and would like to avoid making the same mistake!

List Of All QMS Software

Check it out: We’ve worked hard to create an overview list of QMS Software on the market. We even found some open-source software and added it to the list!

What Is It?

In short, QMS software helps you digitalize your Quality Management System (QMS). Now, please don’t ask me “so what is a QMS?” – well, that’s a much larger topic, sit down on this couch here and I’ll explain it to you..

No, actually not, we don’t have enough time for that as this is this should remain a brief overview! In short, a QMS is a gigantic pile of documentation you have to create, mainly for auditors in specific industries. Our industry (at least the one we write about) is medical software (or rather, medical devices) which is heavily regulated. For some reason, at some stage people thought that writing a lot of documentation and calling it a Quality Management System would actually improve the quality of devices. We don’t have a whole lot of evidence for that, but we did end up with safer devices, so there’s that.

What’s In a QMS?

Regardless, a QMS typically consists of documents which describe:

  • How you do things, e.g. how you manufacture your product (“SOPs”, Standard Operating Procedures).
  • Evidences (records) showing that you actually adhered to those procedures, e.g. test protocols.
  • Customer requirements, how you implemented them in your product, and how you tested them. In other words, you have to document what the hell you actually wanted to develop.

Now, QMS software helps you accomplish that. The typical functionality of QMS software is mainly to manage documents (old dinosaur people in the industry also call that a “document management system”). Your next question might be “why can’t I just use Google Drive?”, and that’s a very valid question – it’s actually possible! I wrote a separate article on how to set up a QMS in Google Drive, but before we get into that, here are the main aspects which make QMS software different from Google Drive. In addition to “only” storing documents, QMS software typically does the following:

  • Has some sort of feature for electronic signing of documents.
  • If you change a document, it saves the old version of the document (versioning) for regulatory compliance reasons.
  • Rarely, QMS software also helps you keep track of your customer requirements and version them, too.

If that doesn’t sound like much, you’re correct! QMS software is rather expensive for the few features it provides. Still, sometimes there are good reasons to choose it. Check out my article on what it is and whether you need it here.

What’s The Difference Between eQMS Software and QMS Software?

There’s no difference – the two terms “eQMS Software” and QMS Software are referring to the same thing, namely managing your QMS in some sort of software. For the sake of simplicitly, I’ll only refer to QMS software in this article.

Do You Even Need It?

As mentioned above, you might not need QMS software. Read my article linked above and come up with your own reasoning.

I think the main point to note here is that QMS software will not save you from understanding the actual regulatory requirements you have to comply with. In other words, if you have no clue about the regulation, purchasing QMS software won’t help you much. I often call this “content over tooling”: You should be able to draft a (crappy) version of your compliance documentation in a simple tool, like Google Drive, first. Only then, when you have a solid understanding of your content, does it make sense to search for a tool which might make your compliance processes more efficient.

What’s The Best One?

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. But don’t worry, you don’t have to attend any shady sales calls – we’ve done that for you!

We compared all QMS software we could find and wrote up our ultimate comparison of QMS software for medical devices. Again, note that we focus on medical device compliance because that’s the area our company operates in. Check out the article here.

Are There Open-Source Options?

Yes, there is! There’s some promising software out there, but the summary (and spoiler) here unfortunately is that all of it sucks to some degree and I wouldn’t choose it right now.

Your choices boil down to a git-based approach with GitHub / GitLab, or something even more custom with Nextcloud and Redmine. Check out this article which compares your open source QMS software in depth.

What About Enterprise 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

Which Software To Choose?

When it comes to QMS Software, you have quite a few choices. Generally speaking, you can either use “specialized” QMS software which is geared exactly towards this purpose, or you can re-purpose more generic software like Google Drive, GitHub / GitLab, Jira / Confluence or Sharepoint.

I wrote quite a few articles on each of those, take a look:

Google Drive

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.

GitHub / GitLab

If you’re a software developer, you’ve probably wondered whether you can simply store your regulatory documentation in git, e.g. on GitHub or GitLab. 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

Microsoft Sharepoint

You can also use Microsoft Sharepoint as QMS software. That being said, I think it’s a terrible choice and there’s a 100% possibility that you will regret this and it’ll make you life a living hell.

Read my post on Sharepoint as QMS to understand why.

Jira Integrations?

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, there’s also our own QMS software called Formwork. It has many cool features and even has a free edition, so you should definitely check it out.

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 consulting? We’re a small company, so we can’t take on everyone – but maybe we have time for your project? We guide startups from start to finish in their medical device compliance.

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