Xenikos B.V. is a private, clinical-stage biopharmaceutical company based in the Netherlands. Their focus is the development of innovative immunotherapies, including T-GuardⓇ, a novel therapy based on toxin-conjugated antibodies, that is designed to quickly and safely reset the immune system in patients with a severe immune disease or post-transplantation rejection.
Like many biopharma companies that have experienced massive growth in a short amount of time, Xenikos found themselves in search of a quality management system (QMS) that could handle their needs. Their homegrown combination of Dropbox folders and Excel spreadsheets worked fine when they only had a few employees. However, once they entered Phase 3 clinical trials for T-GuardⓇ and rapidly added staff, they had to make an upgrade.
“Printed and signed PDFs are ok when you have five people, but with any more than that, it becomes difficult,” said Suzanne Vink-Hermeling, owner of Svinx Consultancy, who advises Xenikos and also serves as their Qualified Person and Quality Assurance Director.
“We needed to become more structured and more in control of our quality system,” added Suzanne. “We had our Change Control requests, CAPA, and Deviations on Excel files, and I had my own ‘To-Do’ list to keep track of actions. When we hired a full-time QA officer, they didn’t have access to my list anymore, so both the document management and quality management systems needed an upgrade.”
It didn’t take Suzanne long to find the right solution for Xenikos. On the advice of a trusted colleague familiar with ZenQMS, she sat down for a demo and liked what she saw. “I looked at ZenQMS and immediately said, ‘This is amazing, this is exactly what we need. It’s easy to do everything we want.”
ZenQMS’ goal is to make the implementation process fast and easy, regardless of whether users are coming from manual, home-grown systems or another eQMS. With a dedicated Project Manager, responsive in-house support, and a Knowledge Base filled with articles and videos, every customer has access to the help and tools they need to get up and running quickly. To that end, Xenikos’ experience was no different.
“It was painless,” said Suzanne of the ZenQMS onboarding process. “We were able to move everything from the sandbox into the live environment and the whole thing went very smoothly.”
ZenQMS makes a dedicated effort to meet or exceed all standards when it comes to GxP and regulatory compliance. These include internationally-recognized certifications like ISO 27001:2013, ISO 9001:2015, and a SOC 2 Type II report. In addition, ZenQMS is 21 CFR Part 11/ Annex 11 compliant as it relates to software validation.
“I want our clients to see that our commitment to quality standards meets or exceeds their own,” said Panos Boudouvas, founder and CEO of ZenQMS.
When asked if she was hesitant about her Netherlands-based biopharmaceutical company trusting a US-based organization with its data, Suzanne wasn’t fazed. “I wasn’t worried about that at all,” she said, as ZenQMS is GDPR compliant.
As a full-time consultant, Suzanne has had plenty of experience using a variety of different eQMS solutions. “I’ve seen other companies’ quality management systems and they're usually way too big or too expensive, and not user-friendly. That’s not what you see with ZenQMS.”
It’s ZenQMS’ ease-of-use that stands out for her and helps the team at Xenikos move quickly through its document management. “We don’t have to go through our old route of making old documents ineffective when we make new ones effective,” said Suzanne. “We don’t have to archive them and update our databases, and we don’t have to make people aware of their training requirements. ZenQMS saves us a lot of time. I wish more of my clients would use it.”
If your Life Sciences company is looking to consolidate quality software tools (especially paper-based ones!), schedule a demo with ZenQMS and let us show you how much easier organizing your quality system can be.