So you’re just starting out with your regulatory compliance journey and asking yourself what the best QMS software is. Even though you’re likely already looking at a few options (and maybe even have offers on the table), my #1 suggestion after working with 100+ companies is to pause and ask yourself this question first: Do you know enough about regulatory compliance to get started, or are you expected a QMS software to magically help you understand what the hell you need to do?
So the answer to “what’s the best QMS software” depends on your answer to that question. Let’s look at each scenario separately.
Scenario #1: You Don’t Know What To Do Yet
Are you just getting started with regulatory compliance? That would be the case e.g. if your current company is the first medical device company you’ve founded in this regulated space. Or you, as a founder or employee, don’t have any first-hand knowledge yet about how the hell to write documentation for a medical device.
I was in that situation in 2018 (i.e., back in the stone age). I had just joined my first startup as a software engineer, and we were trying to figure out what the hell we need to document to get our software certified as a medical device. Then, out of nowhere, a shady salesperson for (at the time) Polarion, a terrible QMS software from Siemens, appeared out of nowhere. He suggested that Polarion would magically solve all our compliance problems, including the fact that we had no clue what we were doing. He even offered to give us some templates on top “for free” to get us started. It sounded like a sweet deal.
Then, we got trial access of a demo account (which is unusual in the shady QMS software market). The software looked like Windows 95 and our entire team failed to figure out how the hell this software works. Maybe it was just us though? It still sounded enticing to pay the dude thousands of Euros to make the compliance headache to go away. Except it wouldn’t go away.
Luckily, at the time, I had just joined and my main job at the company seemed to be to say “no” to various decisions made by twenty-year-old business graduates attempting to run a company, including this one. So I said “no” to purchasing Polarion, best decision ever!
We ended up learning more about regulatory compliance first and actually noticed that we could simply use Google Drive for our first QMS, which was more-or-less free as we were already using Google tools internally. Awesome! So, in our case, at least temporarily, Google Drive was the best QMS software for us.
Oh man, long story. Thanks for reading. And that’s it, end of article.. haha. Just kidding!
I hope you get my message though: If you have no clue about regulatory compliance, eQMS software won’t help you, so stop searching for it. Learn about regulatory compliance first.
Here’s another analogy: Let’s say you want to write a book. What do you do first:
- Think about what to write and sketch out some notes on paper or any other text editor you currently have at hand;
- Start an elaborate search for enterprise text editor software, scheduling sales calls with salespeople and reviewing offers based on “features” and “templates”.
Obviously, when writing a book, your first priority should be to write, and not start an elaborate search for an enterprise editor. I hope I made my point clear?
Cool! Now.. what happens if you know about regulatory compliance already?
Scenario #2: If You Know Regulatory Compliance
Okay, let’s see what you’d do if you already know a thing or two about regulatory compliance. The first question you’d have to ask yourself is whether you want to set up your QMS from scratch in a “generic” tool, or whether you’d like a “specialized” tool which saves you some time, but might be more expensive.
Best QMS Software: Generic Tools
The best generic QMS software tool is the one you’re currently using to store all your documents in.
In many startups, that’s Google Drive; in other companies which are more tolerant of wrestling with terrible software, it’s Microsoft Sharepoint.
The main benefit here is obviously that you don’t introduce another tool to your stack, and you don’t add additional cost to your bottom line. The huge drawbacks, however, are that you have to bolt on additional features for compliance. Stuff like:
- Compliant e-signatures
- Versioning of documents, i.e. keeping old document versions around
- “Linking” of one thing to another, e.g. you have a spreadsheet with product features, and you now have to many-to-many link that to another spreadsheet with product tests (yes, it’s hell).
It sounds painful, but it’s doable. Probably not my recommended approach though if you’re looking for the best QMS software.
Still, here are a few links if you’re interested in this approach: Google Drive Setup | Sharepoint Setup
Best QMS Software: Specialized Tools
Specialized tools don’t have the drawbacks of the generic tools, e.g. they usually have support for compliant e-signatures. However, many of them are targeted towards enterprise customers which means they try to lock in customers with multi-year contracts, no structured data exports and steep price increases once your company grows. Here’s an overview table over the most common QMS software tools:
Greenlight Guru | Qualio | Formwork | |
Pricing | ~30k€ / year | ~30k€ / year | 0 – 0.5k€ / month |
Minimum Contract Duration (Lock-In) | 1-3 years | 1-3 years | None. Cancel monthly |
User Accounts | 3-5 | 3-5 | unlimited |
In addition to Greenlight Guru and Qualio, there are many similar enterprise QMS software providers, e.g. Matrix Requirements and Dot Compliance – their pricing model and feature set is mostly similar.
Needless to say, it’s a super intransparent market, as none of them publish their prices publicly, they only write custom offers to companies like yours as they attempt to extract as much money as possible from you.
Well.. that’s at least how it was, before I started OpenRegulatory. I got frustrated by the whole eQMS industry, and that’s why we tried to build something better! As you might have guessed by looking at the table above, it’s called Formwork: An eQMS with zero lock-in, unlimited users, a free tier and super competitive pricing for its paid tiers. You should try it out. And, look.. even if it’s not for you, it’s free to try out, and you can still move on to our competitors. The inverse is not true: Once you’re locked in by one of the other vendors for 1-3 years, there’s no way to revert your decision.
So the best QMS software, in my opinion, is the one which isn’t shady. It’s a low bar to clear, but.. I guess that’s how the industry operates. For now.
More links: