Watmind USA

Premise

In September 2022, Watmind USA, a global healthcare biotechnology company, approached Rook Quality Systems (RookQS) seeking assistance with enhancing their Quality Management System (QMS) and navigating international regulatory requirements. 

Watmind USA's SARS-CoV-2 detection tests were developed in collaboration with a Chinese manufacturer, which presented unique challenges in aligning expectations and regulatory compliance, particularly as they pursued an Emergency Use Authorization (EUA) for a combined COVID-19 and Flu device.

Scope of Work

Quality Management System Enhancement

Watmind USA needed to upgrade their QMS to a system with a broader scope that complied with FDA requirements. Their initial QMS was focused primarily on distribution activities and did not fully address the comprehensive needs of a legal manufacturer from the FDA's perspective. To address this, RookQS updated their QMS to include design & development activities, management of product labeling, and product inspection; and introduced Watmind USA to Greenlight Guru, a system capable of supporting the QMS scope expansion.

Regulatory and Manufacturing Support

Navigating regulatory requirements was another significant challenge for Watmind USA. With offices in the United States and the APAC region, RookQS provided comprehensive support on two product lines:

• SpeedySwab™ COVID-19 Test
  • The RookQS teams collaborated with WatmindUSA’s Chinese manufacturer to ensure the data and reports supporting the shelf-life were clear and met the FDA’s expectations.
  • The RookQS U.S. team compiled the application and interfaced with the FDA on correspondence related to the COVID-19 test shelf-life extension.
• SpeedySwab™ COVID-19 and Flu A/B Test
  • The RookQS teams supported FDA submission preparation by gathering and reviewing necessary data from both Watmind USA and their Chinese manufacturer.
  • The U.S. team compiled applications and interfaced with the FDA on the combined COVID-19 and Flu A/B EUA.
  • The RookQS APAC team helped review batch records provided by the Chinese manufacturer for test kits used in testing required for FDA submissions and conducted an audit of the manufacturer’s facilities to ensure quality/regulatory compliance.

Engagement

RookQS's hands-on approach facilitated the successful implementation of Greenlight Guru for Watmind. The team efficiently migrated existing procedures and forms, updated the QMS, and customized procedures to meet compliance requirements. 

Additionally, RookQS's U.S. and APAC teams collaborated to facilitate effective communication with the Chinese manufacturer, support FDA submissions for the COVID-19 test shelf-life extension and the combined COVID-19 & Flu A/B EUA, and conduct thorough reviews and audits to ensure regulatory compliance.

Outcome

With RookQS's support, Watmind USA successfully extended the shelf life of their SpeedySwab™ COVID-19 test and obtained EUA for both OTC and POC versions of their SpeedySwab™ COVID-19 and Flu A/B test to sale in the U.S. 

RookQS continues to support Watmind USA, ensuring that regulatory and quality requirements are consistently met by Watmind, their Chinese manufacturer. This partnership has not only facilitated compliance but also paved the way for Watmind USA to bring innovative diagnostic tools to the U.S. market.

The collaboration between Rook Quality Systems and Watmind USA exemplifies how strategic regulatory and quality management support can drive success in the biotechnology sector.

Through comprehensive QMS enhancement and effective regulatory navigation, Watmind USA is well-positioned to deliver high-quality diagnostic tests that meet stringent FDA standards, ultimately contributing to improved public health outcomes.