About Vizuri Health Sciences
Launched in 2009, Vizuri develops innovative personal care products, over-the-counter medicines, and prescription medicines by enhancing the benefits of proven, active compounds found in nature through the development of novel technologies and formulations.
The company was primarily focused on research until 2018, when they shifted to manufacturing. In anticipation of their first commercial product launch, PainBloc24®, the first OTC topical pain reliever for arthritis, Vizuri chose to invest in building a quality organization, with systems and processes that would be scalable and flexible to meet their evolving business needs. The company also needed a balanced ROI for such an investment given its small size and R&D budget constraints.
Tracy Fuller, Senior Quality Assurance Director, quickly recognized that she needed a quality management system (QMS) that would keep pace with their growing list of SOPs and training programs. With the upcoming launch of their first commercial product, the paper-based records that the company had previously relied on would no longer be sufficient. In order to meet their business growth demands, Vizuri hired a team of domestic and international employees and contractors who would all have a hand in the clinical development process. They created a list of requirements that the perfect system would include.
The first requirement for their new QMS was that it had to be paperless. Vizuri did not want to pay $30K in annual fees to store and archive their documents, nor did they want to hire another employee to handle the increased strain on a paper-based system as the company scaled up. The second was that the solution had to be Part 11/Annex 11 compliant. This eliminated many of the popular document management solutions on the market, as not all electronic signatures are created equal in the eyes of world regulatory bodies. The third was that it needed to be able to grow with Vizuri through the commercialization process and also enable Fuller to easily support multiple divisions with discrete SOPs, documents, training, and issues.
ZenQMS checked all of the boxes.
“If we had continued with a manual, paper-based system, we would likely have incurred $30K annually in storage and archiving costs.”
“Having worked for a number of small- and medium-sized biotech companies in the past, I knew that most of the eQMS solutions on the market were very expensive and difficult to implement and maintain.” According to Fuller, “When I discovered ZenQMS, I was excited to learn that it had all of the components we required. It was cloud-based and easy to use, which would make it painless to roll out to our remote employees and contract manufacturing and packaging partners.”
The fact that ZenQMS is fully supported from an IT and Support perspective was also incredibly appealing to the Vizuri team, given that they outsource all of their IT needs and would not have the infrastructure, nor support, to maintain an on-premise system. Furthermore, any hardware would need to be validated to meet regulatory requirements.
The ROI of moving from a paper-based system to ZenQMS is abundantly evident to Fuller and the leadership at Vizuri. Fuller estimates that, “Without a scalable system like ZenQMS, we would need to hire another full-time employee on the Quality team to support current needs. If we had continued with a manual, paper-based system, we would likely have incurred $30K annually in storage and archiving costs.”
Fuller and her team successfully implemented ZenQMS throughout Vizuri and in plenty of time to support the regulatory process and clinical trials leading up to the launch of PainBloc24. They were able to automate management and workflows for documents and training right out of the gate. And when her team was asked to insource product complaints, they were able to bring them into the system seamlessly and ensure that the entire process was Part 11 compliant.
Vizuri has expanded and is now in the process of creating separate business divisions for OTC and Pharmaceuticals. Thanks to her scalable and flexible eQMS, Fuller anticipates that she will be able to support both divisions without additional resources.