Sware is a leading digital validation and process automation across the healthcare, life sciences, and medical device industries. Pulse 2.0 interviewed Sware CEO Ellen Reilly to learn more about the company.
Ellen Reilly’s Background
What is Ellen Reilly’s background? Reilly said:
“I have spent 40 years in the life sciences industry where I started my career in the Quality IT area doing automation implementation and validation. I’ve held roles at large life sciences and pharmaceutical companies like Roche, and worked in a life sciences and technology advisory capacity at PwC. A few years later, I had the pleasure of leading the creation and launch of the DocuSign Part 11 product, a module that helps quality and IT leadership in the life sciences industries meet their legal and regulatory obligations. In many ways, leading Sware – a company that is disrupting the approach to validating software – is a full circle moment for me.”
Formation Of Sware
How did the idea for the company come together? Reilly shared:
“Sware was founded based on a long track record of providing consulting services to life sciences companies to help validate their software. At every stage of the product life cycle, from R&D to manufacturing, the software these companies use has to be validated to ensure it meets requirements from the FDA and other regulators. Every time software is updated – to introduce a new feature, for example – it has to be validated again. Traditionally, this has been a manual, time consuming and costly process that leads to what we call validation debt. Sware’s founders identified an opportunity to build a platform that is workflow and data centric, and can automate processes, therefore transforming how companies manage validation.”
Favorite Memory
What has been your favorite memory working for the company so far? Reilly reflected:
“We know the impact that we’re making for our clients because we hear from them directly and see the results on a daily basis. But having that reinforced from a broader industry perspective and having a leading industry analyst tell me that we are truly bringing something innovative to the market was definitely a high point.”
Core Products
What are the company’s core products and features? Reilly explained:
“We offer a platform, ResQ, which stands for Responsible Quality. We also offer a managed service that will run all outsourced validation for a company powered by our ResQ platform.”
Challenges Faced
What challenges have Reilly and the team faced in building the company? Reilly acknowledged:
“The merger and consolidation in the life science marketplace continues to be challenging. There are a lot of smaller companies being gobbled up by large companies, and that has impacted how we work with them. We have definitely pivoted in some areas now that we have a better understanding of our customer target and how they buy.”
Evolution Of Sware’s Technology
How has the company’s technology evolved since launching? Reilly noted:
“We now have 3 releases a year where we introduce new features and capabilities. We have an established advisory board, early adopter program and process for adding capabilities. Most recently, we have added in API, artificial intelligence, and reporting features to provide better capabilities to support a variety of client needs.”
Significant Milestones
What have been some of the company’s most significant milestones? Reilly cited:
“Our two funding events – Series A and B – were both pivotal moments for us. At our Series A, we were turning a corner where we had proven that we could automate all the traditionally manual processes of software validation, and that there was a real market need and fit for what we built. Our Series B, which we recently closed, is another big milestone because it will allow us to expand our market presence and add exciting new features to the platform, especially around our use of AI.”
Customer Success Stories
When asking Reilly about customer success stories, she highlighted:
“We have several deep customer case studies on our website. For example, one case study shows how we helped a pharmaceutical research company eliminate its validation debt, reassign labor hours equivalent to one full-time employee, and accelerate validation by 75%. Another case study shows how we worked with a biotechnology company to reduce costs, collaborate more easily across sites and reduce validation time by 40%.”
Funding
When asking Reilly about the company’s funding details, she revealed:
“We recently closed our Series B funding in June 2024, bringing total capital raised to date to $26 million.”
Differentiation From The Competition
What differentiates the company from its competition? Reilly affirmed:
“There are a lot of things that make our Res-Q platform different. For example, it provides:
— One Centralized App or a single pane of glass that allows users to stay in a single system for all validation needs
— Data-centric Reports that give an unprecedented level of access to deep and actionable validation data
— Intelligent Risk Assessment to initiate workflows and assign workload based on risk profile to avoid wasteful blanket testing
— Open API Access to Res_Q platform functionality with methodologies and use cases on how best to harness
— Workflow Automation Platform that creates meaningful data and documentation via intuitive workflows
— A collection of 40+ top software automation packages and resources to speed implementation and aid continual validation
Future Company Goals
What are some of the company’s future company goals? Reilly concluded:
“With our recent funding, our main goal and focus right now is expansion. We want to help eliminate validation debt for every organization in the life sciences field that has been hampered with it for far too long.”
