So your company works in a regulated industry (like medical devices, what we specialize in) and you have to set up a Quality Management System (QMS) for compliance reasons. Great. And now you’re looking for QMS software so that you can get it done more efficiently. I often get asked whether there’s any free QMS software out there.
The short answer is “yes”, and the longer answer however is “it’s not necessarily great”.
But before I spoil any further content of this highly interesting topic (I think we all agree that QMS software is slightly more exciting than sliced bread), let’s look at our options and how they compare.
Before we get into those, here are the main three requirements which QMS software has to fulfil:
The short answer is “yes”, and the longer answer however is “it’s not necessarily great”.
But before I spoil any further content of this highly interesting topic (I think we all agree that QMS software is slightly more exciting than sliced bread), let’s look at our options and how they compare.
Before we get into those, here are the main three requirements which QMS software has to fulfil:
- Store documents (and old versions of them!) and perform electronic signing.
- Store structured data like design inputs and software requirements and link them with other things, e.g. system tests.
- Everything is easily exportable for handing it in to your auditors.
With those requirements in mind, let’s finally look at our options! You might have guessed the first one.
Google Drive And Microsoft SharePoint As Free QMS Software
Many startups use Google Workspace for their emails and calendars; and some weird startups use the Microsoft tools, which seem significantly worse and full of bugs, but.. I guess some companies make weird decisions.
Regardless of weird decisions, you can use what I call "generic software" as QMS software, too.
Google Workspace comes with Google Drive, and the Microsoft thing comes with SharePoint, which is like a terrible and buggy copy of Google Drive. Both of those tools fulfil the basic requirements of QMS software: You can manage and store your documents and old document versions in them, and you can do some sort of electronic signing with crappy third-party plugins.
Also, you can enter requirements in a structured way by e.g. setting up a Google Sheet. Linking entries in those sheets with entries in other sheets (e.g. linking design inputs to system tests) is not pretty and commonly ends up becoming a huge mess, but it works, kind of.
While these tools cost money, SharePoint and Google Drive feel like they’re essentially free, because companies already have access to them and they’re typically not purchased specifically to serve as QMS software.
More about Google Drive and Sharepoint: GDrive Overview | GDrive Setup | Sharepoint Setup | Sharepoint Integrations
Regardless of weird decisions, you can use what I call "generic software" as QMS software, too.
Google Workspace comes with Google Drive, and the Microsoft thing comes with SharePoint, which is like a terrible and buggy copy of Google Drive. Both of those tools fulfil the basic requirements of QMS software: You can manage and store your documents and old document versions in them, and you can do some sort of electronic signing with crappy third-party plugins.
Also, you can enter requirements in a structured way by e.g. setting up a Google Sheet. Linking entries in those sheets with entries in other sheets (e.g. linking design inputs to system tests) is not pretty and commonly ends up becoming a huge mess, but it works, kind of.
While these tools cost money, SharePoint and Google Drive feel like they’re essentially free, because companies already have access to them and they’re typically not purchased specifically to serve as QMS software.
More about Google Drive and Sharepoint: GDrive Overview | GDrive Setup | Sharepoint Setup | Sharepoint Integrations
GitHub and GitLab As Free QMS Software: Leveraging Code Repositories for QMS
Now, let’s talk about using GitHub and GitLab as QMS platforms. These tools, traditionally used for code repository management, offer unique advantages for managing quality documentation and processes.
While using GitHub or GitLab as QMS software might sound enticing, we’ve actually decided that it’s no longer a great choice - and we’ve tried hard, believe me! Many of our clients used it, and all of those setups ended up being really crappy. Read more here. Still, let’s look at them one by one. Here’s how they measure up:
While using GitHub or GitLab as QMS software might sound enticing, we’ve actually decided that it’s no longer a great choice - and we’ve tried hard, believe me! Many of our clients used it, and all of those setups ended up being really crappy. Read more here. Still, let’s look at them one by one. Here’s how they measure up:
GitHub As Free QMS Software
When I consult startups which consist mostly of technical people, they often want to choose GitHub as their QMS software. This intuitively makes sense, because they document things in markdown files, and putting them in git for versioning seems like a straightforward approach.
However! The #1 problem with any git-based QMS surfaces once you have to interface with non-technical people, which happens sooner than you think. E.g. you want to collaborate with a regulatory consultant, or you want to submit your documentation to an auditor, etc., etc.. Or maybe you want to hand off your compliance documentation to a non-technical team member.
Good luck explaining markdown and git to them. I've always seen this approach fall apart then, unfortunately. So my recommendation here would be: Don't set up your QMS in git, unless you plan on doing the regulatory work at your company for the rest of your life.
However! The #1 problem with any git-based QMS surfaces once you have to interface with non-technical people, which happens sooner than you think. E.g. you want to collaborate with a regulatory consultant, or you want to submit your documentation to an auditor, etc., etc.. Or maybe you want to hand off your compliance documentation to a non-technical team member.
Good luck explaining markdown and git to them. I've always seen this approach fall apart then, unfortunately. So my recommendation here would be: Don't set up your QMS in git, unless you plan on doing the regulatory work at your company for the rest of your life.
GitLab As Free QMS Software
If you know GitHub, you also know GitLab. People like it because it's self-hosted, which can be useful, depending on your company's requirements.
The TLDR here is that the exact same thoughts apply as for GitHub above. So the TLDR also is: Don't use GitLab as your QMS.
If you still want to set up your QMS in GitHub / GitLab (chuckle), check out this article on how to do it.
The TLDR here is that the exact same thoughts apply as for GitHub above. So the TLDR also is: Don't use GitLab as your QMS.
If you still want to set up your QMS in GitHub / GitLab (chuckle), check out this article on how to do it.
Nextcloud: Self-hosted Google Drive
Nextcloud is essentially a self-hosted Google Drive alternative. You could, in theory, use it as your QMS software. However, the same drawbacks as for Google Drive apply here, too: You're essentially repurposing an existing software and trying to "bolt on" compliant document signing and versioning here.
I wouldn't recommend it.
I wouldn't recommend it.
Redmine: Self-hosted Issue Tracker
Redmine is an interesting one as I looked into it quite extensively when researching open-source QMS software. The idea here is that Redmine is an issue tracker, similar to Jira (although less clunky broken, probably, which is not hard to achieve).
The #1 problem I see with Redmine is about versioning: In short, you need to keep a list of features your software had for each software version, which means that your "list of software features" has to be immutable and versioned. Traditional issue trackers like Jira and Redmine don't come with this sort of functionality.
So Redmine is not an option.
You still could, however, use it for your day-to-day project management which might be a totally different thing than using it for your regulatory documentation. But.. using Redmine for your regulatory documentation is probably not a great idea.
The #1 problem I see with Redmine is about versioning: In short, you need to keep a list of features your software had for each software version, which means that your "list of software features" has to be immutable and versioned. Traditional issue trackers like Jira and Redmine don't come with this sort of functionality.
So Redmine is not an option.
You still could, however, use it for your day-to-day project management which might be a totally different thing than using it for your regulatory documentation. But.. using Redmine for your regulatory documentation is probably not a great idea.
Doorstop: Open-Source Requirements Management (But Not a QMS)
An honorable mention goes out to Doorstop, which is another open-source software. In this case, however, it only covers your requirements management - in short, this means keeping track of the features, risks and tests of your medical device. While you also need that as a medical device manufacturer,, it's somewhat out of scope for this article as we're focusing QMS software here.
And, somewhat unfortunately, Doorstop doesn't provide QMS software functionality.
More about Doorstop: Overview
And, somewhat unfortunately, Doorstop doesn't provide QMS software functionality.
More about Doorstop: Overview
Conclusion & Considerations for Free QMS Software
While free and open-source tools offer cost savings, there are trade-offs to consider:
- Learning Curve: Tools like GitHub and GitLab require technical skills, which may necessitate training for non-technical team members.
- Customization and Integration: These tools may require additional setup or customization to fully meet QMS requirements. This might involve scripting, integrating third-party tools, or even developing custom solutions.
- Support and Reliability: Unlike paid QMS solutions, free tools may lack dedicated support, and their reliability can vary.
- Exportability for Audits: Ensuring that documents and records are easily exportable in a format acceptable for regulatory audits is crucial. This often requires additional effort with free tools.
One important point to note is why people choose free QMS software in the first place. The main reasons for that are that existing QMS software vendors are very expensive, lock customers in for multiple years and don't provide any sort of structured data export. While open source QMS software solves this, this comes at the cost of having to maintain your own infrastructure now, with the worst-case scenario of losing your data if you don't take care.
That's why we developed Formwork: It's a QMS software with a free tier. It's pricing is transparent, you can cancel any month and, if you're unhappy, you can export your structured data any time!
I'm obviously biased here, but if you're looking for free QMS software anyway, you should give Formwork a chance! :)
That's why we developed Formwork: It's a QMS software with a free tier. It's pricing is transparent, you can cancel any month and, if you're unhappy, you can export your structured data any time!
I'm obviously biased here, but if you're looking for free QMS software anyway, you should give Formwork a chance! :)
