Depending on your company’s size, structure, and growth strategy, your eQMS wishlist might look different than that of another QA team, even in the exact same industry. But whether you’re prioritizing training, CAPA management, or something in between, there are a few features every regulated company should mark as must-haves. If you’re looking to move off a manual system or reevaluating your current eQMS, don’t compromise on these four things:
A pricing structure that doesn't inhibit growth
Seat licenses are pretty normal in the quality software industry -- and that can be tricky. Every time you add a new person to your team, you're stuck either justifying an increase in cost or playing a game of musical seat licenses to figure out who gets booted from the system. Or worse, you resort to sharing login information. (Cue the collective QA shudder).
We get it, seat licenses are a tried-and-true business model. But when it comes to establishing compliance and audit-readiness, a growing organization can't afford to be held back by limited seat licenses. Often, it's this kind of pricing that keeps QA teams on outdated workflows and piles the majority of work onto one person.
It doesn't have to be this way.
Seat licenses are common amongst eQMS softwares, but you don't need to settle for them. Alternatives exist. When choosing your eQMS -- or deciding if your current system is worth keeping -- scrutinize the pricing structure. Ask yourself, is it cost effective now? Will it still be in a year? Does the pricing model punish growth?
And if you’re curious how much you could save by replacing your eQMS (or comparing systems for the first time), check out our free eQMS cost comparison worksheet.
Barrier-free access to validation materials
Software validation isn't optional for FDA regulated companies, which means a simple validation process should be on your eQMS must-have list. Not only does successful validation make for an easier audit, it also gives you peace of mind about your data and electronic signatures' security.
Unfortunately, a lot of eQMS companies charge for validation materials and/or for support during this critical phase. You either have to pay hidden fees to leverage their materials or commit to handling it yourself from scratch. And if you’re already using an eQMS that charges for their validation materials, you’ll find yourself paying again if/when it’s time to revalidate the system after a major software update. Those costs add up.
When your compliance is on the line, why compromise for an eQMS that makes validation difficult?
Instead of resigning yourself to hidden fees, shop around for an eQMS that provides free validation materials. Bonus points if they provide no-charge, speedy support from start to finish. More bonus points if they offer qualification checklists or templates.
A user interface your organization will actually… use
As a quality professional, you’re probably pretty well versed in using different quality tools and technology. After all, you’re likely using these systems almost every day. But what about the general user at your company that needs to log into your eQMS a few times a month to stay compliant? If every time they need to complete a training or sign off on an SOP they end up spending ages just trying to navigate the system, you can bet they’ll start to push off their quality assignments.
If you’re spending most of your time chasing down employees to remind them to stay compliant or find yourself retraining your colleagues on how to use the eQMS every time they log in, it’s probably a sign your current eQMS isn’t user friendly.
Ease-of-use should be a top priority when vetting a new eQMS – for admins, yes, but especially for the general user. Pro tip: When evaluating a new platform, ask for a sandbox account you can use to test the system so you can get a first-hand look at just how simple to use it really is.
A system that flexes to fit you
Finding the right eQMS can feel like a guessing game. Too many features and you’re bogged down in a complicated system; too few and your eQMS becomes a speed bump as you grow. Plus, a system that's too rigid and templated means you're forced to adjust your quality workflows to match your software's title conventions, document categories, signature requirements, etc.
If you're on the hunt for an eQMS -- or rethinking if your current system is the right fit -- make configurability a priority. Your system should allow you to adjust forms and stages to match your current processes, configure your workflows, set custom fields, and more. And it should do so without requiring intervention from the software’s development team and without an extra customization fee attached. In short, it should do exactly what you need today and adapt to your tomorrow. It's not about compromising your processes to fit into your eQMS; it's about finding a system that flexes to fit you.
Unfortunately, a lot of eQMS platforms will say they’re able to do this, but when you’re in the system, it’s not nearly as configurable as promised. That’s when it might be time to consider a switch. It may sound daunting, but it’s doable. Read how the Associate Director of QA at a growing clinical trial management company made the business case to replace their outdated eQMS and convinced both the CEO and CFO to approve the switch.
Need help prioritizing your own list of eQMS feature must-haves? We can help.