computer-software-assurance
(3)
PSC Biotech and the business of being believed
A medicine needs more than a promising molecule. PSC Biotech sells the people, software and manufacturing support that help turn scientific ambition into evidence an inspector can examine.
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.
ValGenesis
ValGenesis is the pioneer of digital validation for the life sciences industry. Founded in 2005 in Santa Clara, California, the company invented the Validation Lifecycle Management System (VLMS) - the first proven, 100% paperless, end-to-end validation platform - and now builds Smart GxP, an AI-enabled platform that unifies risk-based validation and process lifecycle management. Trusted by 30 of the world's top 50 life sciences companies, ValGenesis helps pharma, biotech, and medical device makers replace paper-based validation with governed, auditable, AI-assisted digital workflows.