ZenQMS Helps SQ Innovation Seamlessly Configure Their DHF and DMR
About SQ Innovation
SQ Innovation, Inc. is a virtual pharmaceutical combination product company located in Burlington, MA. As their name implies, they develop innovative, cost-effective therapies for the subcutaneous delivery of pharmaceutical products intended to treat edema in congestive heart failure (CHF) patients outside a healthcare setting.
When Senior Director, Quality Assurance – Device, Kirsten Westrate, joined SQ Innovation, the company’s QMS was burdened by an electronic quality management system (eQMS) that was too slow, complicated, and rigid to meet the demands of an agile start-up. Whether it was the system’s difficulty handling different modules, the need for some processes to still be hand-written, or the endless fees for additional seat licenses and storage– nothing about it worked for her.
“The flow of information wasn’t as seamless as it should have been. Signing off on approvals and finding records was difficult. And I was always frustrated with the cost because it was just fee after fee after fee,” said Kirsten. “With that system, more complex processes like CAPA would never meet timelines. That system required too many forms that were all manual with multiple stages of approvals. After my first two months, when I could not get a single procedure routed and approved, I got so frustrated that I said, ‘We’re not doing this anymore’.”
SQ Innovation immediately began evaluating alternative eQMS solutions that would more closely align with how they preferred to work, with an emphasis on ease-of-use and configurability. As an experienced quality leader, Kirsten was well aware of QMS solutions that promote pre-built templates or out-of-the-box workflows as a benefit. Those systems work on day one, but as users begin to perform processes, they find that they’re far too prescriptive, overburdened with complexity, and don’t allow a company to remain adaptive.
“Other QMS solutions come with their own built-in process for DHF and DMR organization or workflows, but the biggest limitation is they can’t be designed around our processes or business needs,” said Kirsten. “I don’t want to be boxed in. I don’t want to have to work the way the vendor requires us to work within their system, let alone be charged additional implementation project fees to make necessary modifications.”
SQ Innovation ultimately decided on ZenQMS, an eQMS that Kirsten had used during her time at a previous company. The system allows her and her team to configure their processes to their specifications and eliminates the frustrations that come with rigid, pre-built templates.
“I looked at all the additional benefits too: unlimited licenses, unlimited storage, backups and recovery, compliance with relevant GxP requirements like GAMP 5 / Part11, and certifications like ISO 9001 / ISO 27001. ZenQMS had those stamps of approval that assured us that they understood the space we work in and the constraints we have for meeting all of our regulations and standards in the drug and medical device development spaces.”
SQ Innovation is a complex organization that straddles the line between medical device and pharmaceuticals. As such, they collaborate with more suppliers than an average company of their size. The ability for SQ Innovation to have their DHF, DMR, and an additional drug development file compiled, searchable, reportable, and accessible to their vendors (with appropriate permissions, of course) has given them an enormous advantage.
“Coming from the medical device space, the DHF and DMR processes in ZenQMS have really been the saving grace for us. Because we have to manage so many records and versions coming from so many suppliers and subject matter experts, we can now seamlessly show those processes, compile the deliverables in one place, and stay audit-ready,” said Kirsten.
“Having all of our design development integrated into one large DHF- and DMR-configured workflow has been a priority process. Harnessing the power of the configurable workflows has been tremendous. We’ve seen amazing benefits and everyone has given me such great feedback. I keep hearing from our team about how easy the system is to use, and how simple it is to find things.
“Getting a system adopted is extremely challenging and it’s not been a problem for us. That’s something I like about ZenQMS and why I wanted to come back to it. It’s user-friendly, it’s self-serve, and it’s easy to perform work without a lot of training. Being able to self-administer our configurations in the system is extremely important because it doesn’t limit us and it doesn’t paint us into any corners.”
For SQ Innovation, ease-of-use and self-administration is critical for Leadership as well. “Our CEO has worked in the software industry, not just in pharma and medical device. He’s very interested in process automation. He wants to be able to find information on his own and start a workflow on his own. Our leadership wants to self-serve. Having the ability to keyword search our entire QMS in one fell swoop has been another benefit of ZenQMS,” said Kirsten.
Again, an important aspect of choosing the right eQMS comes down to how easy it is to move through processes, regardless of the regulated industry. For SQ Innovation, they’re able to add as many stages, reviewers, attendees, records, tasks, and issues as they want to their workflows without difficulty.
“Our business is so different from others that I’ve been at because we’re virtual and we work with so many suppliers,” said Kirsten. “I needed a system that I could build and tailor to my needs without being overburdened. In other vendor’s eQMS systems, I couldn’t even add custom fields to collect additional metadata. With ZenQMS, I’m not pigeon-holed in any prescriptive field.”
When asked about the quantifiable benefits that ZenQMS has over SQ Innovation’s previous system, Kirsten was very clear about what matters to her and her company.
“The main quantifiable benefit is audit-readiness. I want to be able to find my records in one system, not four or five different places. I don’t have to worry about that because I know ZenQMS is my single source of truth."
If you’re looking for an eQMS that works the way you work, or one that’s easy for everyone on your team to use, schedule a demo with ZenQMS and learn how we can make your job easier.