Key Facts about Doorstop as QMS Software
No (you'll need another software)
Yes, this is specialized requirements management software which enables you to manage your regulatory requirements in a compliant way.
Yes, you can try this software out for free!
Yes, you can export your data in a structured way at any time.
No, this software doesn't have a text editor, you have to bring your own editor to edit documents (e.g. Microsoft Word).
No, this software does not have a cloud-hosted option.
Yes, this software has a self-hosted option.
Free (open source)
Doorstop is one of those super-rare open source software packages which are specifically geared towards a regulatory purpose (in this case, requirements management). There really isn’t a whole lot of other open source software in this space.
So, for that alone, I think the developers deserve some massive props. I have a lot of respect for that. If our company ever goes bankrupt, maybe we’d open source our eQMS software (Formwork) which might be, um, both interesting and scary, but until then.. ah, where were we, we actually wanted to talk about Doorstop.
Doorstop is interesting! I suppose the name is a pun on IBM Doors, a typical, crappy, enterprise-q requirements management software. Smart!
All your documentation is stored in a git repository and you modify it by editing files within that repository and committing the changes. From this, we can quite easily infer the pros and cons of Doorstop.
Benefits of Using Doorstop as Requirements Management Software
git as Version Control
Doorstop is integrable with advanced version control software like git, facilitating parallel advancements in requirements, documentation, and implementation. It enables the integration of only those changes that are finalized and ready for incorporation, allowing for synchronicity between implementation and documentation, enhancing operational efficiency.
Given its intricate version control, any modifications in implementation or documentation are interlinked, ensuring cohesive modifications and preventing discrepancies between the different segments of a project.
Doorstop offers detailed changelogs and diffs, allowing users to detect any alterations in a document readily, thus avoiding unnoticed slip-ins and maintaining the integrity of the documentation.
Your Code and Documentation In Sync, Theoretically
Keeping your the code of your medical device software in sync with its regulatory documentation, well, that’s the wet dream of software developers (and regulators, and auditors). In practice, this rarely happens, but Doorstop at least gives you an opportunity to accomplish it as both things, code and documentation, are in git.
There’s still the completely unsolved problem of when to document stuff - do you start writing new documentation before you change your software? During? Or after? And these problems get exacerbated by the fact that your documentation is in git, where its harder to keep “draft stuff” around as it’s either committed or not.
Developers Might Like It
It’s in git, therefore developers are likely going to like it. There’s a huge drawback though: Non-developers will likely hate it, see below.
Your Data Is Exportable!
Everything is in git, therefore your data is easily exportable. Just move the directory and/or the git repository somewhere else.
Doorstop is free and therefore eliminates the burden of license fees, presenting a cost-effective solution for organizations and individual developers.
Drawbacks of Using Doorstop as Requirements Management Software
Non-Developers Might Hate It
All non-developer users of Doorstop will have a terrible, hard time learning it. They not only have to learn git (already a very high ask), but they also have to learn how Doorstop works and the file structure.
In my experience, Doorstop is typically maintained by only one developer in an organization, because even the other software developers don’t want to get in on it. Non-developers are effectively barred from editing and contributing.
Opportunity Costs (Developer Time)
Now, all your requirements documentation has to be written by a developer, because only one developer knows how to use the tool (Doorstop). Developer time is very precious and expensive. Are you willing to make that trade-off?
Long Setup Time, Has To Be Customized
Doorstop is not a “run it and start writing documentation” thing. It takes significant time to understand and set up. This adds to the opportunity cost above.
Also, it has to be customized as it doesn’t provide a compliant solution out of the box. Therefore, the developer in charge will have to read up on the regulatory requirements and make the relevant changes to the Doorstop configuration. This might easily take multiple weeks.
I really don’t want to be too critical of Doorstop because I think, in spirit, it’s a great effort and we should have more of such open-source projects.
The reality, however, is more tricky: It’s very unlikely that Doorstop will be a good fit for most companies. The main problem is that your documentation can only be edited by developers (likely, one developer in particular). This alone is a death sentence for most organizations which rely on a team of multiple people, including non-developers, to take care of their compliance work.