At Greenlight Guru, we pride ourselves on building products specifically for MedTech companies. With more than 1,100 customers worldwide, we take our mission to move MedTech forward seriously.
But the QMS space is shared by more than just medical devices. The pharmaceutical, automotive, and aerospace industries—to name just a few—also require companies to have a quality management system. That’s why vendors like MasterControl exist—they market a highly customizable product to any and all industries that need a quality system.
Because we’re focused specifically on the MedTech vertical, we routinely talk to medical device companies that are looking to switch from MasterControl to Greenlight Guru’s purpose-built QMS. It happens often enough that we decided to put down in writing what you can expect from switching from MasterControl to Greenlight Guru.
Here’s what that change will look like—and how it will benefit your company in both the short-term and the long run.
Flexible workspaces without the validation burden of complex customizations
We regularly hear from our customers who switched from MasterControl that they were initially blown away by all the possibilities MasterControl offered. It seemed like there were practically infinite customizations they could make to get a system built specifically for their business.
In practice, however, customers tell us that the complex customizations required to get the QMS compliant and running smoothly end up becoming overwhelming. Not only does it take much longer than they’d like to customize the QMS for the needs of a MedTech company, but the customer also has to perform ongoing validation of that system to stay compliant.
And, as you may have noticed, customization tends to have a lot of built-in fees. Hearing, “Oh, that costs extra,” gets old pretty fast.
What you end up with is a high total cost of ownership for a complex product that employees find burdensome and difficult to use. In other words, what looked great (tons of available customizations!) ends up becoming a massive time and energy sink.
Built-in compliance safeguards for medical device regulations
When you switch to Greenlight Guru, you may notice that the software isn’t customizable in the same way as MasterControl.
Our competitors often cite this lack of customization as a drawback, but people who have been through the drag of using a highly customized QMS understand that this is actually a huge benefit.
It’s true you can’t customize our software in the same way as you can with MasterControl, but that’s because we’ve already built our QMS for MedTech companies. We’ve built it to be compliant with up-to-date industry requirements from regulations, like 21 CFR Part 820 and Part 11. We’ve built in best practices from the latest versions of ISO 13485 and ISO 14971, and used more than a decade’s worth of feedback from our customers—all in MedTech—to add the features and functionality you’ll need.
Now, you will be able to configure workflows in Greenlight Guru Quality to meet your specific needs. You just won’t have to sacrifice compliance or constantly validate the changes you make.
As Zach Markin, Co-founder and CEO of HTD Health said about Greenlight Guru Quality, “We wanted a tool that was sufficiently flexible that we could bring out preferences and approach, but would still keep us from coloring outside the regulatory lines.”
Customization can sound like fun, but what’s even better is getting what you needed the first time. When compliance is built in from the start and validation is a breeze, reducing risk and increasing efficiency don’t have to exist in opposition to each other—they’re two sides of the same coin.
Accelerated implementation on your terms
Building our QMS specifically for MedTech companies comes with a number of benefits that we can pass on to our customers. And if you’re switching from MasterControl, one thing you’ll immediately notice is that our onboarding and implementation is faster—much, much faster.
I should add a caveat here—there’s still work to be done when it comes to implementation. If you’re at all worried about implementation, check out our no-stress guide to making sure any QMS implementation goes smoothly.
But the truth is that once you’ve run the installation qualification document on your end, you are ready to start using the system. That takes about 30 minutes, by the way.
Will you still need to bring all your documents in? Absolutely. Will you probably need to show up to office hours with your dedicated onboarding and implementation Guru? Sure. But you’re not waiting on someone to let you begin using the system. You’re not waiting for your customizations (and up-charges). You’re in the system and learning how it works.
And speaking of learning, you’ll have the opportunity to jump right in with Greenlight Guru Academy, a MedTech-specific library of over 360 pieces of content, 16 certification courses, and exclusive Advance Membership training—all taught by leading industry veterans.
Because when you switch to Greenlight Guru, you’re getting the legendary customer service of our Gurus—MedTech experts with deep industry knowledge who are always there to help. Just ask Mary Head, Document Control Team Lead at DNAe:
We benefit a lot from Guru Services. We’ve developed a very close relationship with our Guru, Niki, and we ask her anything and she always has an answer. We’re always working together to solve whatever problem we have. It’s been a really good relationship.
That’s probably why G2 recently ranked Greenlight Guru as having the “Best Implementation” and “Best Relationship” and “Best Results” among Medical QMS providers, and has been ranked as a leading QMS solution for 20 consecutive quarters.
With Greenlight Guru, your MedTech company is positioned for success
I don’t want to understate the difficulty of switching from one QMS solution to another, especially if your current solution is complex and requires dedicated team members to oversee it.
But even if you feel like you’re in too deep with your current QMS, there’s always a way out.
What we typically see is that when teams get a high level of buy-in from upper management, they’re given the resources they need to get the transition done. And post-implementation is when you’ll really begin to see the magic. Once all your documents have been transferred and your team starts to use our QMS regularly, you’ll be amazed at what comes standard—no customization needed. You’ll have:
Full lifecycle traceability between design controls, ongoing risk assessments, and post-market surveillance/quality events
A Validation Package that changes software validation from a burden to a breeze
A first-of-its-kind complete risk management solution, aligned with ISO 14971:2019 for streamlined compliance throughout the entire device lifecycle
What does that all lead to? An independent study of Greenlight Guru Quality found that implementing our modern eQMS led to a 50% reduction in time spent preparing for audits, a 75% reduction in the time QA/RA employees spent on mandatory training, and a 50% reduction in time spent on design and development documentation. On top of that, the time required to set up a quality management system was reduced by 75%.
A lot of those time savings come from our modern, intuitive software, but the increased efficiency also stems from the expertise of our medical device Gurus—an unparalleled customer success team with a collective 500+ years of industry experience.
Kristin W., reviewing Greenlight Guru on G2, sums it up well:
Greenlight is great because the platform itself has so many useful tools embedded in one place. You can have your design control matrix, risk matrix, customer feedback, nonconformances, CAPAs and documents in one easy to view platform. Not only is the user interface clean and clear, but the staff are extremely knowledgeable and willing to help!
If you’re ready to make the switch from MasterControl to Greenlight Guru, get in touch with us today. Not only is it possible to switch, but once you’ve upgraded to an industry-specific QMS, the only question you’ll still have is why you didn’t do it sooner.