Case Study: Sandstone Diagnostics achieves an audit-ready, streamlined QMS and accelerated product development with Greenlight Guru

Moving From A Paper-Based Qms To Greenlight Guru

Sandstone Diagnostics, a Bay Area biotech developing the Trak consumer semen analysis system, was operating with a patchwork paper-based QMS and Google Drive folders and had limited experience with Design Controls, which was slowing product timelines. They engaged Greenlight Guru to replace the ad-hoc system with a scalable electronic QMS (Greenlight Guru quality management platform) and to train the team on Design Controls and risk management.

Greenlight Guru implemented its eQMS and coaching program, helping Sandstone formalize procedures, increase team engagement, and regain momentum in product development under co‑founder and Quality Director Sara Naab’s leadership. The results were measurable: regulatory readiness improved (a California Food & Drug Branch inspection took just two hours and led to prompt certification), a successful clinical investigation was completed, and Sandstone is now positioned to pursue a 510(k) submission — outcomes directly attributed to Greenlight Guru’s platform and support.

Sandstone Diagnostics

Sara Naab

Co-Founder & Quality Director