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ZenQMS is the Clear Choice for Uniquity Bio

Customer Story | Uniquity Bio
No charge for validation documents
Set up fees 5x more affordable than competitors
“Unbelievable” support responses times

About Uniquity Bio

Uniquity Bio is a clinical-stage drug development company headquartered in Malvern, PA. They are focused on transforming the treatment of a broad array of immune-mediated diseases through the development and delivery of promising therapeutics, tailored to meet the needs of underserved patient populations.

Business Need

Having worked in both big and small pharma for years, Uniquity Bio’s Vice President of Compliance & Quality, Patti Ward, knows what she wants when it comes to electronic quality management systems (eQMS): ease-of-use, ease-of-validation, and affordability. So when it came time to choose a system for Uniquity Bio, she urged Senior Director of Quality Assurance and Compliance, Theresa Sheehan, to learn more about the quality solution she’d enjoyed at her previous employer: ZenQMS.

“One of the biggest drivers for me to have ZenQMS at Uniquity Bio, other than its intuitiveness, was the customer support,” said Patti. “I’ve worked in a QA department of one, with other responsibilities besides my work in quality management. ZenQMS’ support got me through validation, UAT, and document migration quickly at my previous company. I wanted that same experience here.”

Given that she and Theresa had previously worked together, Patti wanted her to be comfortable with the system as well as its capabilities. “I’d used a different eQMS at a previous mid-sized pharma company,” said Theresa. “I led the implementation and I can tell you that the process was very cumbersome and time-consuming. You had to work within their limits so it was restrictive. I needed something easy-to-use that wasn’t over-engineered.” 

When Theresa spoke with ZenQMS, she learned why Patti recommended it so strongly over other eQMS solutions. Unlike her previous, restrictive system, ZenQMS is configurable, allowing Quality Directors like her to build processes the way they like. Everyone at Uniquity Bio has access to all the modules without ever having to worry about seat license availability. And the clear, intuitive dashboard gives her a clear view of her entire team’s training status in seconds.

It’s safe to say that what they got with ZenQMS is a quality solution that satisfies all of Uniquity Bio’s needs and more. “It’s been a really great experience”, said Theresa. “Patti came in and told me all of these great things about ZenQMS, and she was right.”

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Business Impact

Right away, Theresa received a set of validation documents from ZenQMS with a full IQ/OQ/PQ at no charge to make sure the software was fit for their use. Next, she went through User Acceptance Testing, which she easily completed without a consultant because of ZenQMS-provided DIY templates and accessible customer support. “The response times were unbelievable,” said Theresa. “Especially coming from my most recent experience with [a different eQMS] where we’d never get that type of service. The whole process was seamless.”

What Patti and Theresa appreciate about ZenQMS support is that it continues throughout the relationship, especially after a software update, where release notes and validation reports are provided at no additional charge. “As the user and administrator, the information given to me in that release package really helps because I am not an IT person, I’m a QA person,” said Patti. “It helps me evaluate the impact of how I’m using the system and whether or not I need to test it again.” 

“ZenQMS allows us to take the next step.”

On a related note, another reason why Patti wanted to bring ZenQMS to Nexstone was because of the price. Compared to other eQMS’ they researched, ZenQMS was overwhelmingly more cost-effective. “[Competitors’] set-up fees were five times more expensive, and those systems aren’t any better! They’re much more complicated to use and not intuitive at all.”

Patti continued, “ZenQMS allows us to take the next step. We have Documents and Training modules in place now. When we want to bring those other three modules in, it won’t cost us anything. Other companies charge per module and it’s another full implementation.”

ZenQMS’ functionality and ease-of-use were designed with every organization’s entire staff in mind, which is why there are no seat license fees. “We can support the non-GxP groups at Uniquity Bio when they need everyone to sign-off on a document. We can pull it into ZenQMS, execute electronic signatures, and follow up with training. It’s helpful because we’re able to use it to support a lot of different company activities without costs standing in the way,” said Patti.

If your regulated organization could benefit from an intuitive, affordable, and functional electronic quality management system, schedule a demo with ZenQMS and learn all the ways we can help.

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