Webinar Available On-Demand
By: Sandra K. Rodriguez, Market Analyst
For decades, life sciences companies have implemented on-premises quality management systems (QMS) to support regulatory requirements and replace paper-based processes. These systems were often implemented to mitigate regulatory findings rather than to create visibility, traceability and accountability throughout the product lifecycle. Today, companies are taking a different course and are adopting a cloud culture to modernize processes, improve supplier collaboration, and drive better quality and business outcomes.
I was recently joined by Joe Vigil, Director Quality Systems at Ultragenyx, and Mike Jovanis, VP Vault Quality at Veeva Systems, to discuss the achieved business benefits of a cloud-based quality solution on a webinar presented by Veeva Systems.
We discussed the internal and external factors that are contributing to the adoption of Cloud QMS and the benefits of an industry cloud platform including time to value and reduced validation efforts.
With merger and acquisition activities a daily reality in the life sciences industry, companies are growing at rapid rates. “We started our journey to a cloud QMS about three years ago in 2017. At that time, we had about 350 employees and no commercial products. Today we’re over 750 employees and have two commercial products. So, we’ve grown quite a bit in a few years’ time, and we really were looking for a cloud solution that could grow with us,” said Vigil.
Life sciences companies are directing their resources toward developing next generation products and improving patient outcomes rather than building and managing complex IT infrastructures. An industry once obsessed with paper is changing its course. Upgrading outdated on-premises solutions puts a significant strain on resources and budgets.
Companies that were once cloud averse are becoming cloud curious when it comes to leveraging the cloud for quality management. “It takes away the burden and the overhead of managing an on-premises solution, which typically comes with servers, underlying software and a level of technical understanding. With a cloud solution, that isn’t required anymore. And being able to focus just on the use of application and quality as a discipline allows organizations to maximize their efforts on bringing better-quality products to market faster,” added Jovanis.
Today a wide range of cloud solutions are available in the market, but they don’t offer the same capabilities. For example, the horizontal cloud solutions on generic platforms provide some benefits including access anywhere and infrastructure management, but they aren’t specifically built to cater to the needs of life sciences organizations. On the other hand, an industry cloud solution for life sciences includes the benefits of general-purpose cloud and is tailored to the specific needs of a particular industry.
An industry cloud vendor provides cloud-based applications, data, professional services, and business best practices that continue to evolve and improve with new learnings or business needs. “Veeva very specifically exists as an industry cloud vendor. We have technology that has been built from the ground up for the quality space, and it is delivered with a regiment of best practices. With Veeva’s cloud applications, companies are always on the latest version and have access to the latest capabilities and best practices to meet their quality and compliance needs,” commented Jovanis.
Vigil shared the industry perspective on what led to his organization to adopt best practices and leverage an industry cloud solution. “Having a system that is easy to use with workflows that are aligned to the tasks people need to perform, and importantly, an ability to easily extract information out of the system were key decisions for us.”
In traditional organizations, where on-premises solutions have been the norm, there are misperceptions and concerns around validation, security, and availability of cloud solutions. However, leading cloud providers have been designed from the ground up to meet very stringent government, regulatory, global standards, and availability requirements. “Security concerns, not having control of data and accessibility by other companies (unauthorized access) were some of our initial concerns,” said Vigil. “We reviewed the vendor procedures and associated validation and then focused our validation activities on the high-risk areas. For us, this meant customized workflows, and really looking at the security settings and making sure that those were set appropriately so that people had access to the fields and workflows that they needed. And importantly, they didn’t have access to items that they shouldn’t have access to,” added Vigil.
Cloud solutions are generally based on industry best practices and do not require customization or heavy configuration during implementation. “This offers a benefit of a faster time to value for organizations, but it also does require a culture change that companies are willing to adapt to a vendor best practice as opposed to spending large amounts of effort configuring what they view as their own processes,” said Jovanis.
The cloud offers mobility, accessibility, and a device agnostic secure environment for quality data. When it comes to the pros, cons and pitfalls to avoid, Vigil offered these thoughts: “in terms of lessons learned from our initial implementation and my own manufacturing background, an old adage comes to mind: sometimes you need to go slow to go fast. And for us, we really wanted to take that to heart and spend time to really focus on the process and the roles that are needed to interact with the system.”
Whether your organization is cloud-averse, cloud-curious, cloud-comfortable or has already taken a cloud-first approach, request your copy of the eBook “Adopting a Cloud Culture in Support of Improved Quality and Business Outcomes” to learn how to transform Quality Management with a modern cloud solution.