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.
Iâll try to give you an overview over all your software options below. Note that this is somewhat of an overview article, so Iâll 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, youâll hopefully have a solid understanding of what QMS software is, you hopefully didnât fall asleep, and you hopefully have understood enough so that you wonât make a mistake when choosing the right software.
Letâs get started!
New: The True Shadiness Of This Industry
Weâve 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 youâre 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: Weâve 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 donât ask me âso what is a QMS?â - well, thatâs a much larger topic, sit down on this couch here and Iâll explain it to you..
No, actually not, we donât 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 donât have a whole lot of evidence for that, but we did end up with safer devices, so thereâs 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 (âSOPsâ, 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 âdocument management systemâ). Your next question might be âwhy canât I just use Google Drive?â, and thatâs a very valid question - itâs 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 âonlyâ 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 doesnât sound like much, youâre 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.
Whatâs The Difference Between eQMS Software and QMS Software?
Thereâs no difference - the two terms âeQMS Softwareâ and QMS Software are referring to the same thing, namely managing your QMS in some sort of software. For the sake of simplicitly, Iâll 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 wonât help you much. I often call this âcontent over toolingâ: 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.
Whatâs The Best One?
Thereâs quite a lot of QMS software out there. Those solutions are often difficult to compare because their vendors donât offer demo accounts or only shady demo calls in which they walk you through some shiny slides. But donât worry, you donât have to attend any shady sales calls - weâve 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 thatâs the area our company operates in.
Check out the article here.
Are There Open-Source Options?
Yes, there is! Thereâs some promising software out there, but the summary (and spoiler) here unfortunately is that all of it sucks to some degree and I wouldnât 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 canât 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: Donât 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 âspecializedâ 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 itâs not perfect, it may be a reasonable choice if youâre a small startup on a budget. Have a look at our
post on how to set it up.
GitHub / GitLab
If youâre a software developer, youâve 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 itâs a terrible idea.
First, have a look here how to set it up:
Setting Up A QMS In GitHub / GitLabThen, understand why itâs 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 itâs a terrible choice and thereâs a 100% possibility that you will regret this and itâll 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.
Thereâs 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, itâs a topic worth discussing.
Hereâs our article:
QMS Software And Jira / GitHub / GitLab Integrations: Donât Make a Mistake!
Formwork
And finally, thereâs 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.
