Quality and Compliance

Genosity is committed to ensuring patient safety and providing services with high-quality standards that meet all relevant regulatory requirements and contractual obligations. We work closely with our clients to choose the right platforms, genomic assays and bioinformatic pipelines best suited to deliver results fulfilling their needs as well as ensuring appropriate level of compliance. We understand that preserving the integrity of your samples (and associated derivatives) as well as delivering quality data is key for the success of your projects. Genosity has implemented a set of processes and programs intended to ensure the integrity, confidentiality, and availability of your data.

• Genosity’s laboratory is CLIA-certified and College of American Pathologists (CAP)-accredited.
• Our lab is licensed in the states of NJ, NY, CA, MD, RI, and PA.
• Our QMS complies with regulations used for the conduct of clinical testing as well as regulated studies such as Good Laboratory Practices, Good Clinical Practices, and 21 CFR Part 11.
• Periodic monitoring of a variety of key indicators in order to identify trends and recognize activities and processes that may be improved.
• Staff, suppliers, and processes are continuously assessed and monitored through competency and audit program by our independent QA team.
• Assays are validated according to strict acceptance criteria. Genosity participates in CMS-approved proficiency testing program.
• Privacy program that allows to ensure data security, confidentiality, and integrity in order to meet customers, federal (HIPAA Rules), and international requirements (GDPR).
• Computer systems are validated based on risk in accordance with ICH E9 and GAMP guidelines.
• Our facility has been intentionally designed to ensure the integrity of your samples and derivatives, and adherence to OSHA guidelines with the goal to ensure a safe working environment for our staff.

Since inception, Genosity’s leadership team has created a culture founded on ethical values and the desire to place quality at the core of our services. This commitment is demonstrated through the five pilars of our Quality Management System (QMS)