“The proof is in the pudding. We passed our California audit with flying colors. She was in and out in 2 hours and sent us our certificate in the mail, no questions asked.” - Sara Naab, Co-founder & Quality Director
Sandstone Diagnostics is a Bay Area biotech company developing instruments and consumables for point-of-care medical testing. Sandstone’s lead product, Trak, is a consumer semen analysis platform that provides a simple and accurate way to monitor sperm quality from the comfort of home.
Making the decision to become a Greenlight Guru customer made perfect sense for Sandstone.
Prior to engaging Greenlight Guru, the company was working with several consultants in the areas of quality and regulatory.
A quality system had been drafted and somewhat implemented. It was a combination of paper-based documents and Google Drive shared folders. However, it was a mess and it didn’t take long for the quality system efforts to be ignored by nearly all the Sandstone team.
Additionally, the Sandstone team didn’t have much experience with Design Controls and saw their timelines slipping.
From day one using Greenlight Guru, our objectives with Sandstone was very clear:
Establish a QMS that is clear and scalable. Train key personnel on the QMS. Teach them how and why.
Teach and coach the team on Design Controls and Risk Management.
Focus on their critical product development needs.
You see, this is how Greenlight Guru works with customers. We are partners.
And within a couple months, significant measurable progress on QMS, Design Controls, and Risk Management was being made.
We had the opportunity to work with Sara Naab, co-founder and quality director. Sara took ownership of the QMS. She guided her team through the process of reviewing and approving procedures and ensuring the necessary documents and records were being generated and maintained.
Her leadership on the quality side was key.
“As expected and as hoped, our processes got a lot simpler. Our team was a lot more engaged in the quality system. So now everyone understands the quality system. Everybody uses the quality system.”- Sara Naab, Co-founder & Quality Director
With QMS progress being made, Sandstone was quickly recouping some of the lost time with product development efforts. The company was preparing to conduct a clinical investigation of their novel device. One obstacle that stood in their way was an inspection from the California Food & Drug Branch.
Because of their organization and efforts with the QMS using Greenlight Guru, that inspection lasted only 2 hours.
Fast forward several months later, with a successful clinical investigation completed, Sandstone Diagnostics is on the verge of a FDA 510(k) submission. The Greenlight Guru platform has been key to Sandstone’s progress to date.
We’re excited for Sandstone Diagnostics and their quest for the launch of their product.