computer-system-validation
(2)
Sware
Sware is a Boston-based software company that modernizes GxP validation for life sciences. Its cloud-native Res_Q platform and developer-focused GxPNext product use AI and a decade of regulated validation knowledge to automate the computer system validation (CSV) work that the FDA and other regulators require - helping pharmaceutical, biotech, medical device and CDMO teams cut validation time and cost while staying audit-ready. Formerly Boston Technology Research (BTR), the company rebranded to Sware in 2022 and has raised roughly $26-27M to date.
Ellen Reilly
Ellen Reilly is the Chief Executive Officer and a board member of Sware, a Boston-based software company building Res_Q, an AI-powered GxP validation platform for the life sciences industry. With roughly four decades in life sciences quality and IT, Reilly has worked at Roche, advised clients at PwC, and led the launch of DocuSign's Part 11 product before taking the helm at Sware in 2023. She frames her work as tackling 'validation debt' - the accumulated, unpaid cost of testing and compliance that slows how quickly pharmaceutical and biotech companies can adopt new software.