Why Your Company Needs a QMS Software or eQMS

Technology is rapidly changing the way medical device companies can create, deliver, and store records and documentation. Nowhere is this more evident than in the divide between paper-based and software-based quality management systems (QMS). 

Compliance, productivity, timelines, and finances are all affected by the quality of a company’s QMS. And for growing companies especially, there is simply too much at stake to rely on a paper-based system. With paper, you risk non-compliance, drastically slow down productivity, and lose the speed of operation that gives startups their natural edge over entrenched competitors. 

And yet, nearly a quarter of the way into the 21st century, many MedTech companies still opt to run their QMS on paper or spreadsheets (when we refer to paper, we’re also talking about “digital paper” tools like Excel, Dropbox, or Google Drive).

So, let’s take a look at why these companies are choosing paper, the problems they will inevitably run into, and what they should be doing instead.

FREE DOWNLOAD: Click here to download the PDF version of Why Your MedTech Company Needs QMS Software Instead of Paper.

Paper documentation is slow, inconvenient, and even dangerous

These days, it’s rare to find a MedTech company whose entire team is in a single building. Sometimes they’re not even in the same country. A paper-based system is inconvenient (to say the least) for companies with distributed teams. It makes collaboration difficult and puts a damper on genuine teamwork. 

What happens is that teams who started out with a real determination to turn an amazing idea into reality slowly succumb to mountains of paperwork. Time spent chasing signatures or trying to find the latest version of a document is time wasted. It’s a distraction from the work that the team thought they would be doing when they got into the medical device industry. 

But a paper-based QMS isn’t just inconvenient. It also presents major compliance problems. Many companies are already using electronic methods for communication and documentation without considering the issues that creates. 

Sending an email attachment? That’s creating an electronic document. Scanning a document with a signature? That could be a sensitive document that’s now in an inbox with little security or validation.

There’s also the matter of ensuring documents are current and accurate. In many cases, an electronic version of a document is thought to be the most up-to-date, but how can you really ensure it is without revision tracking? Solutions like Dropbox and Google Drive may offer high-level tracking, but not in a fashion that’s compliant with FDA 21 CFR Part 11 or can be validated per FDA regulations. 

These problems add up quickly, both in time and money. Every new change order or document revision creates drag within the business, and soon it feels like even the smallest step forward takes enormous effort. 

A paper quality management system makes audits a nightmare

Every medical device company needs to be audit-ready at all times, but paper-based systems make that level of document control nearly impossible. Physical paper documents are lost all the time. Electronic paper documents—like the Excel sheet you’re using for design controls—are similarly easy to misplace, delete, or accidentally change. 

I can guarantee that by using a paper-based system, you will have missing documents and records. You will have missing signatures. And you won’t be able to explain it away when an auditor is asking for that document. Trust me, you do not want to be scrambling to find a document in an audit, especially if there’s a good chance it no longer exists. 

That lack of control can also cost significant time — something that is already a precious commodity for companies in a highly competitive space like MedTech. As I mentioned earlier, emailing documents can introduce errors. 

If you’re sending a document for someone (or even multiple stakeholders) to sign, for instance, it has to go through several inboxes before it can be put back together. If that document is missing signatures, the process has to start all over again. With an ad-hoc filing system that isn’t validated, audits will always be unpleasant.

Paper can’t keep up with regulatory changes

The industry tends to be afraid of regulations like 21 CFR Part 11, and for good reason: it can take a lot of time and effort to stay compliant. While regulations like Part 11 offer guidelines that ultimately make workflows safe, repeatable, and secure, those guidelines can seem overwhelming. Sometimes it feels safer to just keep getting wet signatures and dealing with the hassle than to change to a new system.

The problem is, the regulations do change. In the EU, the Medical Device Regulation (MDR) is a massive change from the old Medical Device Directives (MDD). In the US, we’ll soon see a version of 21 CFR Part 820 that incorporates ISO 13485:2016 by reference. That new regulation (the Quality Management System Regulation, or QMSR), will be here before you know it. 

New guidance documents come out all the time. FDA just changed its stance on software validation in 2022. What I’m getting at here is that your paper-based QMS doesn’t change when the regulations change. When you’re using paper, it’s all on you to ensure compliance. 

With quality management software like Greenlight Guru Quality, however, you can have some peace of mind that you won’t be overlooking regulatory changes in your quality program. Out-of-the-box compliance means you have the guardrails to keep you compliant now and a team of experts ensuring you aren’t surprised by any changes. 

What should you look for when choosing quality management software?

The choice of a particular eQMS will depend on your business, your products, what your team is comfortable with, and how you intend to scale. There’s a lot to consider when evaluating different QMS software and building the case for the eQMS you want. 

But regardless of the solution you choose, there are some key takeaways here that I’d urge you to keep in mind as you go through the process.

• Paper is no longer a realistic choice. Hopefully by now you understand the downsides of a paper QMS, but I want to reiterate it here—paper should not even be on the table. Not only is it costly and time-consuming, it introduces the potential for preventable errors within your QMS, and that’s just not acceptable given the industry we’re in.

• Regulations and standards are there for your benefit. The regulatory frameworks in different parts of the world can seem overwhelming (especially if you’re trying to comply using paper), but they are ultimately there for the good of both patients and the MedTech companies who serve them. These regulations, like Part 11, can also act as guidelines for choosing QMS software. Do the different options you’re considering all come with compliance to MedTech regulations built-in? Or there significant work that goes into making the software comply?

• Customization and validation will slow you down. Remember that there is a tradeoff when it comes to customization. A highly customizable system will require time to implement, and new configurations and changes will require significant time to validate. A tool that comes with every bell and whistle imaginable may be exciting at first, but the shine can come off quickly once you realize how much time will be required to configure it just right and then maintain validation.

FREE DOWNLOAD: Click here to download the PDF version of Why Your MedTech Company Needs QMS Software Instead of Paper.

Greenlight Guru’s eQMS is built specifically for MedTech companies like yours

Moving on from paper doesn’t have to entail transitioning to an overly complicated eQMS that slows you down just as much. 

Instead, you have the option to choose QMS software that was purpose-built for medical device companies. Greenlight Guru Quality doesn’t require extensive customization—it’s compliant with FDA and EU regulations and ISO standards like 13485:2016 and 14971:2019 out of the box. 

We built Greenlight Guru Quality so MedTech companies could switch from paper with confidence. Instead of wondering if your new QMS solution is even more complicated than paper, you now have the option of a simple, secure, and compliant QMS system that was purpose-built for your needs. 

If you want to learn more about how Greenlight Guru Quality makes it easier than ever to let go of paper, then get your free demo of our software here →