Articles Questions

Updated December 2, 2022

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

Dr. Oliver Eidel

Question

We’re looking for QMS software. It’s important for us that it has a Jira / GitHub / GitLab integration because our development and project planning happens in one of those tools. We want to re-use as much of this documentation for regulatory purposes. Best case, the developers shouldn’t have to create any additional documentation at all.

Short Answer

What you’re looking for doesn’t exist. Even if you had a perfect QMS software with a perfect Jira / GitHub integration, it wouldn’t help you very much. You have to create a lot of documentation from scratch anyway, regardless of integrations.

Jira / GitHub / GitLab integrations are useless for QMS software. Their main purpose is to convince you to buy the software - not much more.

Long Answer

Let’s look at an example.

You’re using Jira for project planning - you create epics and user stories in it, and all sorts of other tickets which developers should work on (bug reports etc.). That works well for your company (even though I personally despise Jira, but let’s not go there today). Good for you!

Now you’re thinking: “Hm, we need to do all this medical device compliance stuff soon, and we have all of this documentation in Jira. If we manage to integrate Jira with a QMS software (an eQMS), maybe we can magically create all required documentation automatically and don’t have to distract the developers with regulatory documentation tasks?”

You talk to a few salespeople for enterprise QMS software. Lo and behold, they all offer great Jira integrations and promise you that yes, you can automate everything with those! Just, um, sign their offer and pay a huge sum for their software, and they’ll get you set up!

Sorry to burst your bubble here, but what they are selling is not true.

Why is it not possible? Let’s look at a documentation example: Software requirements. One of the regulatory requirements is that you document something called a “software specification”. In simplified terms, that’s a list of features which your software has for a specific version. It could look like this:

  1. The software has a login screen with an email field, a password field and a submit button.
  2. If an invalid email / password combination is submitted, the error blablabla is displayed.
  3. Alternatively, users can log in with Google by clicking “Login with Google”.

Okay, cool. Now, ask yourself: Is this the level of documentation you currently have in Jira? I’d argue this is not the case for 100% of companies. In reality, the Jira backlogs of companies look like this:

  1. As a user, I want to log in with email and password.
  2. Implement login with Facebook.
  3. Fix login with Facebook.
  4. Remove login with Facebook.
  5. Implement login with Google.
  6. Fix error messages when logging in.

Okay, now, those tickets describe the same thing, but if you’d export all of them and send them to an auditor, would that person be able to understand how the login screen looks for a specific version of your software? The poor auditor would have to merge all those tickets in their head and come up with a summary of their results. Impossible as soon as we’re talking about more than a few tickets. And typically there are hundreds.

So our learning from all of this is that, generally speaking, regulatory documentation has to be written from scratch and can’t be compiled from your existing stuff in Jira or GitHub. Sad dog face. That’s the way things are.

And that already answers the questions whether a Jira / GitHub / GitLab integration for a QMS system makes any sense at all: No, it does not.

What makes sense instead? How do you get the regulatory stuff done fast? You have these two factors which determine most of your speed:

How fast and minimalistic you are able to create your documentation. This is determined by writing it in a simple way - like, less than 50 software requirements and a similarly low number of risks in your risk table. And also using tools which help you quickly write things from scratch. Our QMS software, Formwork, is perfectly suited for exactly this. It helps you write documentation really, really quickly. It has predefined forms for everything and guides you in documenting exactly what you need to pass an audit.

How minimalistic your templates are. All the speed in the world is useless if your consultant provides you with completely overengineered document templates to fill out. I’ve seen software development “plans” which span 30 pages. That’s insane! Our template is about one page. That’s a work reduction by a factor of 30! Try achieving that with a crappy Jira integration! Did you know that we provide all our regulatory documentation templates for free? They cover all the standards you need for software medical devices, they’re minimalistic and best of all, yes, they are free!

So there you have it. You don’t need a Jira integration. If you want to gain speed, this is how you do it. And if you’re now looking for a better QMS software, check out Formwork.

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!

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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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