BOSTON– Sware, provider of the most complete software validation solution for innovative life sciences companies, today announced that it raised $6 million in Series B funding, bringing its total raised since inception to $26 million. The round was led by First Analysis, which joins a syndicate of existing investors that includes LRVHealth, New Stack Ventures and Insight Partners. The funding will be used to bolster research and development of Sware’s computer systems validation (CSV) platform, Res_Q, to further streamline processes with artificial intelligence (AI), and to expand the company’s sales team so it can bring the platform to more organizations struggling with validation debt, the unpaid cost of release, testing, GxP, and business requirements. As a result of the funding, Matt Nicklin, managing director at First Analysis, will join the company’s board of directors.
Innovation in the life sciences and biotechnology sectors continues to accelerate rapidly. For example, approvals for new drugs from the U.S. Food and Drug Administration (FDA) reached an all-time high in 2023 and more than 9,000 medicines are currently in development globally, across therapeutic fields. Advancements in technology, including cloud computing and artificial intelligence, have been a major catalyst for driving this wave of innovation, but they have also introduced new challenges.
Regulatory bodies around the globe, including the FDA, require companies to validate computer systems used for development and manufacturing to ensure data integrity, security, and reliability. This task has become increasingly difficult as software companies embrace agile development and continuous delivery of new code.
“Every time a life sciences company adopts a new technology, or every time technology vendors update products, validation requirements add time and unforeseen expenses that only compound as products move towards commercialization. Automating these processes is the only way to eliminate this validation debt,” said Ellen Reilly, CEO of Sware. “We have deep experience helping life sciences companies through these processes and we’ve built everything we’ve learned into the Res_Q platform. This funding will enable us to scale the impact we’re making towards eliminating validation debt and to continue innovating with AI-driven capabilities for even smoother automation.”
According to Gartner®, “Life science CIOs and IT leaders have long struggled with the challenge and additional expense of CSV, with some Gartner clients estimating that CSV adds 30% to overall project costs.”1 In addition, McKinsey and Company estimates that the cost of quality assurance in the medical device industry affects 12% to 18% of industry revenue.
Through the Res_Q platform, Sware enables pharmaceutical, medical device and biotechnology companies to automate, integrate and scale their validation processes. Res_Q is a cloud-based platform built with an open API architecture that allows organizations to control all validation processes – for IT, manufacturing, lab systems, and more – in a single system. With intelligent risk assessments to initiate workflows and assign workloads based on risk profile, Res_Q puts quality at the forefront without sacrificing speed.
“What sets Sware apart is their deep domain understanding and associated expertise of the relevant requirements and technology. They are highly agile, committed and most importantly flexible in providing solutions meeting our immediate and long-term requirements,” said Alvin Coleman, vice president of information technology at G1 Therapeutics.
“There’s nothing more important in life sciences industries than product quality and patient safety. As life sciences companies rely on more advanced technology to speed innovation, software quality assurance is a critical component to meeting the highest safety standards,” said Matt Nicklin, managing director at First Analysis. “We’re investing in Sware because its proven technology can help companies escape the growing challenges of validation debt and more importantly, empower them to bring new innovations to market more quickly, efficiently and safely.”
