“When I discovered ZenQMS, I was excited to learn that it had all of the components we required and was cloud-based which would make it painless to roll out to our remote employees and contract manufacturing and packaging partners.”
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 introduced PainBloc24®, the first OTC topical pain reliever that can help provide 24-hour arthritis pain relief with as little as one application every day. PainBloc24® utilizes a patented NeuroMax® formula, that consists of several safe, non-active ingredients that enhance the tolerability and effectiveness of the naturally-occurring, FDA-recognized, topical analgesic, capsaicin.
In anticipation of their first commercial product launch, Vizuri chose to invest in building a quality organization including systems and processes that would be scalable and flexible to meet their evolving business needs.
The Vision: Paperless and Part 11 Compliant
Tracy Fuller, Senior Quality Assurance Director, quickly recognized that she needed a system 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 realistic for the business. In order to meet business growth demands, Vizuri had hired employees and contractors all over the world who would all have a hand in the clinical development process..
The company needed a solution that was paperless, but also Part 11 / Annex 11 compliant, which eliminated many of the popular document management solutions on the market since not all electronic signatures are created equal in the eyes of world regulatory bodies They needed an electronic Quality Management System that would grow with Vizuri through to commercialization and would enable Fuller to easily support multiple divisions with discrete SOPs, documents, training, and issues.
“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 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 and was cloud-based which would make it painless to roll out to our remote employees and contract manufacturing and packaging partners.”
The cloud-based software was particularly appealing to the team at Vizuri 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 Business Impact
Fuller and her team have successfully implemented ZenQMS throughout Vizuri and in plenty of time to support the regulatory process and clinical trials leading up to the launch of their first commercial product, PainBloc24. They were able to automate the management and workflows for documents and training right out of the gate. 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.
In the past year, 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.
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 FTE on the Quality team to support current needs and if we had continued with a manual, paper-based system- we would likely have incurred $30K annually in storage and archiving costs.”