Case Study: Watmind USA achieves FDA compliance and EUA success with Greenlight Guru and Rook Quality Systems

How one global healthcare biotechnology company is benefitting from the solutions of Greenlight Guru and Rook Quality Systems

Watmind USA, a global healthcare biotechnology company, needed help upgrading its quality management system (QMS) to meet FDA requirements for its COVID-19 and flu diagnostic tests. The company worked with Greenlight Guru and Rook Quality Systems to expand a QMS that had been focused mainly on distribution into one that could support legal manufacturer activities, including design and development, labeling, and product inspection.

Greenlight Guru, implemented with guidance from Rook Quality Systems, helped Watmind USA migrate procedures and forms, customize its QMS, and support FDA submissions and manufacturer coordination. As a result, Watmind USA successfully extended the shelf life of its SpeedySwab™ COVID-19 test and obtained EUA for OTC and POC versions of its SpeedySwab™ COVID-19 and Flu A/B test for sale in the U.S., positioning the company for continued regulatory compliance and market growth.

Watmind USA