Quality & Compliance

At Diversigen we know how important every sample is to microbiome research – that is why each of our services are built on a rigorous foundation of quality and compliance policies that ensure repeatable, accurate results that our customers can depend on. 

Our services are performed in our CLIA licensed, CAP accredited facility in New Brighton, Minn, USA.  Our Quality Management System is built on the principles of ISO15189 and aligns with international requirements for RUO, pre-clinical and clinical testing, including, but not limited to: GCP (Good Clinical Practice) and GLP (Good Laboratory Practice) and applicable privacy & security requirements.  

We adhere to all applicable requirements to ensure data privacy, security and quality including: 

• Quality management system includes an independent QAU and QA team GCP & GLP as applicable to services 
• Data integrity and security controls 
• Document control policies, procedures, staff training and work instructions 
• Test validation, verification, and controls 
• Rigorous internal controls are integrated into all workflows spanning from sample shipping and chain of custody through report generation and data delivery 
• Equipment management program including IQ, OQ, PQ, calibration and PM 
• Business continuity plan and testing controls 

Partner with Diversigen to have confidence you are receiving high quality data outputs and reporting. Check out our services to see how we can best support your discoveries.