Quality
Standardizing the life sciences supply chain
To complement our industry-leading supply chain solutions, Cryoport Systems has a robust, tested, and trusted quality system to provide our clients with confidence and certainty in our processes. Cryoport Systems works closely with ISTA, IATA, ASTM, as well as other internationally recognized and accredited bodies to design, develop, and execute verification and validation studies. In recent history, our expertise was an integral part of the development of ISO 21973:2020, General Requirements for Transportation of Cells for Therapeutic Use.
Our quality systems and processes include:
- Chain of Compliance® – traceability of equipment, processes, and logistics in support of critical material transportation around the world.
- The Cryoportal® Logistics Management System – validated to demonstrate compliance to 21 CFR Part 11 and ISPE GAMP5.
- The industry’s only validated cleaning process for temperature-controlled packaging, Veri-Clean®.
- Complete temperature records of transported materials maintained minimally for 10 years.
- An extensive historical data depository to assist risk-based decision-making.
- Instituting Good Manufacturing Practice (GMP) standards and Good Distribution Practice (GDP) standards where applicable.
- Involvement with FACT (Foundation for the Accreditation of Cellular Therapy) & SCB (Standards Coordinating Body).
- ISO 9001:2015 certification.
- ISO 21973 compliance.
Innovative Solutions
Learn more about our innovative solutions and how we apply our extensive quality systems to everything we do.
Or contact us for more information about our Quality Management Systems and Validation Documents.