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MOLECULAR LOOP PREPARES FOR ISO 13485 CERTIFICATION WITH HELP FROM ZENQMS
About Molecular Loop
Molecular Loop is a life science tools research and manufacturing company based in Woburn, MA. They deliver targeted next-generation technology that enables genetic testing to be more cost- and time-effective and accessible for clinical applications and large-scale research projects.
Success Highlights
Business Need
Greg Porreca, CEO of Molecular Loop, had a decision to make. The original plan for his company was to focus on designing innovative gene sequencing kits for Life Sciences applications and outsource their manufacturing efforts. But when the pandemic hit, and they adapted their technology to include COVID-variant monitoring, that’s when everything changed.
Their easy-to-use pathogen-monitoring kits attracted the attention of the Centers for Disease Control (CDC) and LabCorp, and forced Molecular Loop to rethink their business plan. “We quickly decided that, in order to serve key customers in the best possible way, we needed to bring our manufacturing in-house,” said Greg. “To do that, about a year ago, our young company started a plan to build a quality system that would eventually be ISO 13485 compliant.”
ISO 13485 standards specify the requirements a company’s quality management system (QMS) must meet, in regards to designing and manufacturing medical devices. Molecular Loop tapped Maryke Appel, Founder and President of EXO Consulting, to help them build and implement a QMS. At the time, they didn’t know which eQMS vendor they were going to use. But Greg and Maryke had strong opinions about which ones they weren’t.
“My first company was a genetic testing lab, so of course, we had a quality system,” said Greg. “Everybody hated the QMS software we used there! We were primarily using it for doc control and change control and the interface was a nightmare.”
“I had an extremely bad experience working with my first eQMS,” said Maryke. “In terms of functionality and support, it was horrible. When I talked to clients about their systems, most people hated what they had signed up for; they were big, laborious, took years to implement, and required an implementation specialist.”
After immediately crossing off some of the more cumbersome eQMS solutions on the market, and researching a few others, Molecular Loop decided that ZenQMS was the right fit.
“ZenQMS is much better. It’s a system people want to use, instead of something they dread,” said Greg.
Maryke added, “It’s affordable, the support is excellent, and I like the fact that you get access to all the modules. One thing I’ve been very impressed with is that you guys understand Quality Management.
Business Impact
Molecular Loop has revolutionized the speed and simplicity with which targeted genetic sequencing tests can deliver results, without compromising quality. And just as impressively, they’ve done it in a short amount of time. “We’re building the airplane as it’s flying,” said Greg. Both he and Maryke credit ZenQMS with helping them build an agile, right-sized QMS poised for ISO 13485 certification.
“We’re very proud of how far we’ve come in the last year, especially considering the amount of resources we’ve needed to allocate to building out our QMS,” said Greg.
“The flexibility, functionality, and support from ZenQMS is what has made this possible,” added Maryke. “When you build a quality system, it needs to look professional. With ZenQMS, our quality operations can be as professional as our products.”
One reason why they’ve been able to move so quickly towards ISO 13485 certification is because they weren’t bogged down by their software validation process, an exercise that ZenQMS Panos Boudouvas feels should be simple and painless:
“We are most passionate about empowering teams who are less experienced in the computer software validation (CSV) process-- in fact, we organized our entire process to be simple enough for anyone to understand. Our goal is to make sure you look like quality rockstars when you get inspected.”
An easy validation process was exactly what Molecular Loop was looking for. Maryke estimates that in terms of FTE units, Molecular Loop has had to devote less than half of one employee to building and implementing the software side of its QMS, freeing up resources to focus on other areas of quality management, and the business more broadly.
“Even without dedicated resources, we were able to do our risk assessment and user acceptance testing very quickly,” said Maryke. “The pre-configured package is really impressive and makes it so much easier, especially for small companies. ZenQMS already anticipated the requirements and we just had to pull out what we needed.”
It’s clear that Greg and Maryke are pleased with how ZenQMS has helped them build their quality system, but perhaps the biggest endorsement is how enthusiastic they are about their upcoming inspection.
“I’m looking forward to our first audit!” said Maryke. “We are confident that our auditors will find it easy to navigate our QMS and our records of compliance.”
If you’re in the market for an eQMS that supports your validation efforts and keeps your company moving forward, schedule a demo with ZenQMS to learn more.