Sware, a provider of the most complete software validation solution for innovative life sciences companies, announced that it raised $6 million in Series B funding, bringing its total raised since inception to $26 million. This funding round was led by First Analysis, which joins a syndicate of existing investors that includes LRVHealth, New Stack Ventures, and Insight Partners.
This funding round will support research and development of Sware’s computer systems validation (CSV) platform, Res_Q, further streamline processes with artificial intelligence (AI), and 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. In connection with the funding round, Matt Nicklin, managing director at First Analysis, will join the company’s board of directors.
Innovation in the life sciences and biotechnology industry continues to accelerate rapidly. For example, the FDA’s approvals for new drugs reached an all-time high in 2023, and 9,000+ medicines are currently in development across therapeutic fields. Advances in technology, including cloud computing and AI, have been a major catalyst for driving this wave of innovation, but they have also introduced new challenges.
Innovation in the life sciences and biotechnology industry continues to accelerate rapidly. For example, the FDA’s approvals for new drugs reached an all-time high in 2023, and 9,000+ medicines are currently in development across therapeutic fields. Advances in technology, including cloud computing and AI, have been a major catalyst for driving this wave of innovation, but they have also introduced new challenges.
Regulatory bodies worldwide, such as 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.
With 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. Through intelligent risk assessments to initiate workflows and assign workloads based on risk profile, Res_Q puts quality at the forefront without sacrificing speed.
KEY QUOTES:
“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. 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.”
- Ellen Reilly, CEO of Sware
“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.”
- 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. 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.”
- Matt Nicklin, managing director at First Analysis
