THE CHALLENGE
Satsuma Pharmaceuticals (Satsuma) is a pharmaceutical innovator that is committed to providing novel treatments to those who suffer from migraine and other debilitating conditions.
Satsuma needed to transition from clinical trials to a commercial operation, but its previous electronic quality management system (eQMS) was not robust enough to effectively enable this transition.
Satsuma realized that it would need an eQMS with processes that align with Good Manufacturing Practices (GMP) and would provide automated vendor management, document control, and training effectiveness tracking.
THE SOLUTION
In its quest for a solution, Satsuma turned to Dot Compliance. The software’s out-of-the-box usability and the vendor module for maintaining vendor qualifications were key factors.
Janera Harris, Senior Director of QA & Compliance at Satsuma said, “The free trial allowed our users to access the system and use the different modules. We met with Dot Compliance weekly to answer any questions that arose. This allowed our users to see if the system met their requirements.”
In terms of usability, Harris said, “We did not need to customize the product and Dot Compliance was usable for us right out of the box. In addition, the projected amount of time from setup to launch aligned with our timeline.”
BENEFITS
The Dot Compliance eQMS significantly improved document revisions, change control, and quality event processes and made it easier to capture data and track signatures, leading to greater efficiency and cost savings. The solution seamlessly integrated with Satsuma’s existing systems and processes, without any compatibility issues.
Harris highly recommends Dot Compliance’s quality management software. “Our experience with Dot Compliance has been a very positive one,” she said. “The attention that is given to the customer and any issues that arise is very impressive.”
Satsuma’s success story showcases how well-implemented quality management software can transform operations, improve compliance, and drive growth.
