AssisTek is a leader in innovative eClinical technology and eSource solutions for clinical research based in Doylestown, PA. Founded in 1998, assisTek is an innovative technology company that provides software and solutions for collecting patient data in the clinical research and healthcare industries. Their TEK Studio platform allows flexible adaptation to support their clients’ needs.
AssisTek’s eCOA platform is designed with the patient in mind, resulting in more reliable reporting of outcomes and results. Their eCOA solutions are highly scalable, customizable, and efficient. Additionally, assisTek’s eCOA solutions are powered by a proven, cloud-based technology platform and are delivered with the resources of experienced project managers and customer support teams.
As a rapidly-growing software company working with GCP/GMP-driven clients for 25 years, assisTek knows the value of moving off of paper systems. Just as their own clinical trial solutions are easy-to-use, efficient, and 21 CFR Part 11 compliant, they were looking for the same benefits in an electronic quality management system (eQMS).
“We came from a manual system,” said Sophia Achuff, Senior Manager of Quality Assurance. “It was working okay, but we’re in a high growth mode right now and we needed something that was going to be more scalable. This need had been growing for a while and it became clear that we had to get a full service platform in place.”
With speed-of-implementation taking priority, assisTek began their search for a suitable eQMS. ZenQMS came highly recommended by a current customer at an industry conference, so they reached out. After completing a demo, assisTek was convinced ZenQMS was the right system for them and began the implementation process immediately. “ZenQMS checked all of the boxes and beyond,” said Sophia.
ZenQMS was able to give assisTek exactly what they needed: an intuitive eQMS that was easy to set up in a matter of weeks. “Our first meeting with ZenQMS was at the end of April, and by mid-June we were up and running, with all of our employees able to access the system,” said Sophia, who oversaw the implementation. “It’s been a seamless transition for us. All of the feedback I’ve gotten has been that ZenQMS is easily accessible and user-friendly.”
When asked about the implementation and her experience with her ZenQMS project manager, Sophia had only good things to say. “For the most part, we were able to do it without help from a consultant. I was able to implement at my own pace, and whenever I needed an answer, I’d reach out to ZenQMS and would always get a quick response.
Sophia discovered that, much like assisTek’s software allows customers to design clinical trial projects based on their specifications, they could configure their own existing processes in ZenQMS for more familiarity and ease-of-use. “We were able to upload our documentation, grant permissions and access, and change the settings for individual courses and documents, and it went pretty smoothly. It’s been great seeing everything transformed into an electronic system.”
Now that their eQMS has been implemented, Sophia remarked how, in just a short period of time, ZenQMS has removed many of the pain points assisTek experienced with their manual QMS. “Even things as simple as managing employee training in the dashboard, quickly being able to see who’s up-to-date, who’s missed training, and what training has been completed - those are big things for our quality assurance.” She added, “Just having all of our SOPs in one place is a very valuable asset!”
If your regulated company is interested in the benefits of an eQMS without the long, painful implementation, schedule a demo with ZenQMS.