Members of the Life Sciences Quality Leaders Forums met in Princeton, New Jersey to discuss the ins and outs of audit preparedness in the midst of an ever-changing regulatory environment. Ed Morris, President and CEO of The Morris Group, shared his expertise with the group, suggesting that the first step should be to thoroughly evaluate your organization’s Quality Management System (QMS) and identify any gaps.
Intelligent Quality is an approach that is rooted in the digital transformation that we’ve seen across all lines of business over the past decade or so. The complex, modern organization has tools available in their ‘back office’ that offer data analytics and valuable insights to company leaders- enabling them to make informed decisions about their business strategy. We have seen the explosion of growth and advancement in CRM and ERP, for example, and there is no reason for quality and compliance teams to continue to use stone- age tools.
Marken, a UPS company, is the only patient-centric supply chain organization 100% dedicated to the pharmaceutical and life sciences industries. Marken maintains the leading position for Direct to Patient and Home Health care services, biological sample shipments, and offers a state-of-the-art GMP-compliant depot network and logistic hubs in 54 locations worldwide for clinical trial material storage and distribution.
“We’ve never had a user specific action oriented system until Zen. Whatever you put in, you can also get out- that makes it a lot easier to track progress on individual users but also on a department level.”
“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.”
-Tracy Fuller, Senior Quality Assurance Director, Vizuri
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.”
John Mandy participated in thousands of audits during his 26-year tenure as a Quality Leader at Pfizer. Early on, Pfizer had thousands of GMP suppliers and CMOs located all over the world. In any given year, Mandy’s audit teams were executing over a thousand internal and external audits and assessments. But even he was surprised when he was helping a site prepare for a significant re-inspection and had a local QA lead proudly show him a validation qualification for a new paper shredder. That was just one of many times that he observed teams not taking a risk-based approach to systems validation.
I often speak to quality leaders and other executives who boast that their paper-based quality management system is “perfectly sufficient” to meet the needs of their business. I just nod and smile because I anticipate that I will be hearing from them (in a panicked state) in the very near future when they realize the limitations of a manual QMS.
Janet Woodcock made headlines (again) by discussing the possibility of a quality rating system to aid transparency in her recent blog. But the devil is in the details when it comes to ratings for a site’s quality maturity.
Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen.
The mission of the Quality Leaders Forum (QLF) is to exchange knowledge and build a community of the best quality leaders in the life sciences industry. We will learn from one another and confront the challenges associated with compliance today – and in the future.