- Why Us
The team at DNAe is working to bring cutting edge medical technology to market in the form of an easy-to-use diagnostic platform that delivers rapid results by performing genomic analysis on a microchip.
DNAe’s LiDia-SEQTM DNA sequencing system is built to host a range of tests that will provide vital, actionable information to clinicians at the point-of-need, getting results faster and helping to save lives. Right now, the team’s main focus is on developing infectious disease diagnostics, starting with a groundbreaking test for bloodstream infections (BSI) and antimicrobial resistance (AMR). Using whole blood specimens, this test will detect and identify the infections that lead to sepsis within hours.
DNAe’s started their quality system journey using a generic software solution that wasn’t specific to medical devices. When they got tired of trying to make it work for them, they decided to switch to a paper-based QMS.
But for a company with team members on different continents, a paper-based QMS was a massive headache. People didn’t always have the access to documents they needed and the time difference between teams made collaboration across sites extremely difficult. The quality system was also beginning to get out of hand.
“We were trying to make our quality system global, but we didn’t have a right-sized quality system. It was an older system and it was just getting out of control," said Mary Head, Document Control Team Lead at DNAe.
Mary knew that without the right QMS solution, their problems with the size of the quality system and document management were only going to get worse. DNAe needed to make a change, so they turned to Greenlight Guru.
DNAe chose Greenlight Guru because it was MedTech-specific and would help them implement their QMS quickly—while making sure it was right-sized for their business.
“It’s the only software platform specifically designed for the medical device industry. So I said, ‘We need to have this.’” - Mary Head, Document Control Team Lead
When DNAe implemented Greenlight Guru, they were able to quickly transfer their legacy documents, establish their SOPs, and carefully map out the rest of their transition.
They also chose to purchase Greenlight Guru’s SOP Templates because they saw the value in the library of SOP templates, work instructions, and forms they would always have access to in Greenlight Guru Academy. The template package gave a kickstart to their core QMS documentation and helped them feel confident they were staying compliant every step of the way.
Mary and the team at DNAe have gotten the most out of their partnership with Greenlight Guru. The QMS software is an integral part of their business, and it’s changed the way they work and collaborate across time zones.
It’s hard to keep a quality system streamlined and right-sized for your business, but as the team at DNAe found out, Greenlight Guru’s QMS software makes it easy to keep your quality system under control.
DNAe has taken advantage of practically all the features in the QMS. They use it for change orders, document management, design controls, training management, and the newly re-designed risk management workspace.
“We really love the Flexible Document Organization (FDO). We’ve put our training matrix in that. We’ve set up our FDO in a really streamlined way, and now we have all our growth management documents for training in there and set up shared views for everyone.” - Mary Head, Document Control Team Lead
By using everything Greenlight Guru has to offer, DNAe has kept their quality system manageable and streamlined processes like training and document management for better collaboration and compliance.
DNAe has also made the most of the elite Customer Success team at Greenlight Guru, affectionately known as the Gurus.
“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,” Mary said.
DNAe is also taking advantage of the Guru Assist option, which lets customers ask questions via chat rather than getting on a call. For quick questions, especially when it comes to standards and regulations, they’ve found Guru Assist to be an invaluable addition to the customer service they get.
But the relationship isn’t just a one-way street, either. Mary and her team have been quick to share their experience with Greenlight Guru’s software and suggest improvements when they have ideas. That’s just one of the reasons DNAe was selected by Greenlight Guru’s Customer Success team to receive a customer award at the True Quality 2022 conference in San Diego.
“It’s been a great relationship. Our company is definitely benefiting from the customer service that we get. We feel special because of the time spent answering our questions and concerns and listening to us when we have suggestions for improvements to the product.” - Mary Head, Document Control Team Lead
The team at DNAe was able to implement their quality system quickly, but that’s not the only time-savings they’ve experienced. Knowing that all their documentation is in one place, and being able to quickly find what they need, saves the team huge amounts of time compared to their paper QMS.
“I don’t have to chase people down. I don’t have to read a million emails. I don’t have to put files in different places. I don’t have to worry about people changing or deleting something they shouldn’t. I know who has rights to do what inside Greenlight Guru, so I’m not worried.” - Mary Head, Document Control Team Lead
If Mary has one piece of advice for someone reading this story, it would be to implement Greenlight Guru and get the SOP Templates.
“Save yourself a lot of shopping around and agonizing over what QMS to pick. I’ve been there, I’ve done that, and in my opinion, there’s really nothing that compares to Greenlight Guru as far as medical devices are concerned.” - Mary Head, Document Control Team Lead
DNAe is currently developing tests for multiple healthcare applications, including BSI pathogen identification, antimicrobial resistance, viral and pandemic, and liquid biopsy for diagnostics and monitoring.