Since we launched our own QMS Software, I’ve been approached a gazillion times by companies who wanted to buy it and requested a demo. Those were some very interesting calls!

What surprised me the most was that many companies have no clue about QMS software. I mean, that’s like walking into an Apple Store and having no clue about Macbooks.. hm. That actually sounds plausible. Anyway, I’ve summarized all questions and answers here so that you’ll hopefully be less clueless once you decide to purchase Formwork Pro (right?) and hop on a demo call with me.

What the Hell Is QMS Software? Do You Need It?

You typically would attempt to use (more on that later) QMS software when you have to run a Quality Management System (= QMS) in your company. Now.. what the hell is a Quality Management System? Good question. It’s mostly a huge bunch of documents in which you describe processes of your company. And those activities are generally aimed towards improving product quality (don’t get me started on that one though).

Okay. Now, where does QMS software come into the picture? Again, nobody knows for sure. A typical company interested in Formwork Pro would approach me like this: “So umm, we have to set up a QMS and we have absolutely no clue where to start, but we thought that if we use Formwork that everything’s going to become easier for us”.

Nope, sorry, that won’t work. It’s a bit like when you want to learn a new language and are pondering whether to purchase new, shiny text editor software. I mean, you could, but it’s not going to save you from having to learn the language. It also won’t make you faster. Well, maybe, very far down the line, you’ll be more efficient, because writing essays in a slick text editor is easier, and your main source of language learning will be writing essays. But that’s kind of a micro-optimization. If you want to learn a new language, your resources with the highest leverage on efficiency are learning resources - like, a good course, books, and videos or a good teacher.

The same applies to QMS software!

If you’re in the early stages of understanding what a QMS is and how to get your regulatory compliance done, a QMS software simply isn’t going to help you much. You need learning resources (by the way, check out our wizard) and, if you want to speed things up, consulting. But a QMS software isn’t going to help you.

I like to call this approach “content over tooling”. You shouldn’t care about QMS software yet when you’re just understanding what sort of documentation you actually have to create. I mean, just create it in Google Docs, it’s easy to migrate to a more compliant system later.

So that’s hopefully clear now - you don’t need QMS software if you’re just getting started.

Now, how do you get started? Typically, your activities should be:

• Reading standards while not falling asleep (get them for a good price from the friendly Estonian site).
• Choosing document templates to get started (ours are free).
• Starting to write draft documentation based on those templates, while having lots of questions which hopefully get answered by someone (check out our free Slack community or our consulting).
• Selecting a notified body which understands software and can give you a prospective audit date (not easy nowadays). We’ve compiled a database of anonymous reviews to help you choose the right one.

Okay, once you’re well on your way there and have a basic understanding of what your regulatory documentation entails, you’re ready to look at QMS software! Are you just as excited as I am?

Let’s see where QMS software comes into the picture now, for real.

QMS Software: Which Features (And Benefits) Does It Have?

Roughly speaking, there are three areas in which QMS software can help you do things more efficiently: Document management, fancy features, and requirements management. Let’s go through all three.

QMS Software as Document Management System

For regulatory compliance, you have to generate valid electronic signatures on documents and you to archive old document versions. Those two things sound trivial but they’re actually not - or, not always.

The requirements for electronic signatures depend on the country you’re in and the regulatory authority with which you’re trying to comply. In simplified terms, for medical devices, the requirements in the EU are more relaxed than in the US. In the EU, you can pretty much come up with your own implementation and use whatever tool you want, while US FDA compliance requires e-signatures which are compliant with a regulation called 21 CFR Part 11.

In even more simplified terms, for the EU, you could just use Google Docs and type your initials in a signing table at the bottom - that’s valid because the version history enables you to track who typed those initials (= the person who signed the document). In the US, that wouldn’t work and you’d need a regulatory-compliant tool (Formwork is, by the way).

Besides valid e-signatures, you have to archive old document versions. That’s also easy to accomplish, but can become cumbersome depending on which tool you’re using. If you’re using GDrive for document management, you can’t fully rely on the (internal) version history of a document as there’s no hard guarantee that that’ll be around forever - e.g., when you copy a document, its version history gets lost. So you have to copy-paste documents any time you want to edit them, and archive each copy, one for each version. Ugh, super painful.

You could of course use something like GitHub / GitLab for your QMS version control - but then everyone in your team has to be able to write markdown files which is typically not the case for regulatory people. So that’s where QMS software delivers a real, tangible benefit, because typically there’s a document editor, and document versions are archived properly (again, Formwork does that pretty well, but definitely check out how other QMS software does that, too).

QMS Software With Fancy Features

Now you might ask: Wait, QMS software is only a fancy word for “signing and versioning documents”? And I’d generally agree with you. Most QMS software out there is built by enterprises and sold to enterprises. In other words, it’s super crappy! It often looks like it was built in the nineties and never updated (which could actually be true).

More “modern” (chuckle) QMS software often has additional features. These features really depend on whatever the software vendor built, so there’s no generic feature set like for document management above. I’ll just talk about some examples from Formwork to give you a better understanding.

• User Training: For medical device compliance (= compliance with the ISO 13485 in the EU), you have to prove that your employees have been trained on your company processes. As ridiculous as that may sound, it ends up being a huge documentation pain. Companies typically “solve” this by doing in-person or remote training sessions after which everyone has to (electronically) sign an attendance sheet. Sometimes employees even have to do a quiz afterwards. I wonder.. if you treat your employees this way, I’m not surprised if they end up leaving and going to Google. Anyway! QMS Software can have built-in training modules which make this less painful - they present users with whatever documents they should read and generate proof (something like an attendance sheet) that the user has been trained.
• Audit Preparation: When you get audited, you typically have to send over all your documents in your QMS. Depending on how you manage them, this can be very painful - like, if you use GitHub, you have to convert all markdown files to PDFs and include attachments? Hm. Anyway, QMS Software sometimes has the feature to batch-export everything which saves you a lot of time.
• “Ticketing” Stuff: For medical device compliance, there’s a fixed set of stuff you have to track. For example, those include problem reports with your software. You have to keep records of all of those, prove that you’ve assessed them and track that they’ve actually been solved. This is often done in spreadsheets (or Jira.. uuuuggghhh) which ends up being a mess. QMS Software sometimes has specific forms for these things and it helps you keep track of them.

QMS Software For Requirements Management

And finally, QMS software can help you with requirements management. This is actually out of scope because, well, requirements management is usually done in.. requirements management software? But the lines are becoming blurry, especially in medical devices, as requirements management and quality management are often required by the same regulations and done by the same person. So it make sense to lump them together in the same software, hoping that that will help companies who use it.

What is requirements management? Roughly speaking, you have to list all of the features you wanted to build into your software (regulatory people sometimes call it “design input”), how you implemented it (“design output”) and how you checked that you built it correctly, e.g. by doing software tests (“verification”).

This ends up just being a huge list of many-to-many related things. Like, you could have the design input of building an app to diagnose Covid, that feature could be implemented through many means (design output) and you again could have multiple tests covering that feature (verification). By now you probably have noticed that documenting this sort of data in spreadsheets ends up being a mess of gigantic proportions. But most companies actually do it that way! Ugh, so painful.

This is where software really helps, because many-to-many relations can be easily implemented.

Now, can’t you just use GitHub issues or Jira tickets (ugghh) for that? Yes, in theory, but, just as in document management, you have to keep old versions of your tickets around! That’s actually very tricky, because you also have to preserve the relations. Like, you have to show which design inputs you had for version 1.0 of your software and which verification covered those, even though you’re already developing version 5.0 of your software.

So this is tricky on a technical level. A hacky solution could be exporting all your GitHub tickets and their relations as a PDF, and archiving that somewhere. But that sucks, of course.

This was one of the most complex technical challenges when we built Formwork, and we solved it there. But, as far as I know, other QMS vendors have also solved this problem, albeit in a more mediocre way.

Do You Need QMS Software?

So, do you need QMS software? You tell me! I strongly recommend you to first get started drafting your documentation in a simple tool like Google Docs / Google Sheets. Once you have a good understanding of your pain points, migrate to a more sophisticated QMS software.

Formwork Community Edition is free and perfect to get you started. But feel free to check out others.

And don’t fall for crappy enterprise software. You don’t purchase things like GitHub or IntelliJ from shady companies with annoying salespeople, so why would you purchase QMS software any differently? Choose vendors with free trials, a transparent pricing model, and a product which is optimized for startups. Wait, currently, I know only of one QMS software which fulfills those criteria, haha..