IRONSHORE PHARMACEUTICALS CHOOSES ZENQMS TO PREPARE FOR COMMERCIALIZATION

Prior to launching their first commercial product, DELEXIS, Ironshore used a functional, but insufficient quality management system (QMS). It consisted primarily of paper-based documents and SOPs in a cloud-based file storage solution that was not part-11 compliant and relied on wet ink signatures. As company leaders completed their FDA filings and prepared to bring DEXEXIS to market, they set forth to implement necessary, critical business systems including an eQMS for document management and a learning management system (LMS) for training.  

Ritesh Mehra, Manager of Quality Systems at Ironshore, was charged with selecting both a QMS and LMS that would meet their business requirements and ensure quick implementation given the short runway leading up to commercialization of DELEXIS. When he realized ZenQMS offered a single, integrated, and validated solution that would solve all his needs, the decision was clear.

“We settled on ZenQMS because it’s very simple, intuitive and user-friendly. Even from a Super User/Administrator standpoint, the learning curve is quick. If you just gave me the application with no training or documentation whatsoever, I could probably find my way around on my own.” 

Even better, as a commercial company, the fact that ZenQMS also includes components for prosecuting CAPAs, Deviations, Complaints, and Change Control was also a big win for IronShore.

Once the validation procedure was in place, ZenQMS implementation took less than a month. This process included training and onboarding for each department, as well as a customized project plan for each team. What really impressed Mehra was that he was able to run the project using very few resources on his side. The implementation was coordinated by their personal ZenQMS project manager with help from their customer support team. And the fact that ZenQMS’ validation was trouble-free made a huge difference.

Currently, ZenQMS has been deployed on the commercial side of the IronShore, for quality document management as well as training and tracking. Mehra noted that, “Because it was so easy to implement and easy-to-use, we are also planning to implement it on the R&D side of the business. They have more records that need to be retained, training will be more in depth, and change control will be used there as well.”