Mastering Compliance: How Cryoport Upholds Industry-Leading Standards
When you’re entrusting your embryos, eggs, or sperm to be shipped, trust is everything. You want to know that every precaution and regulation has been met and that the company handling your materials treats them with the care and precision they deserve.
That’s where Cryoport Systems sets the standard.
Our work in reproductive shipping goes far beyond moving materials from point A to point B. We operate under the most rigorous compliance framework in the industry, because the families we serve deserve nothing less. From ISO 21973 compliance to our proprietary Chain of Compliance® and Veri-Clean® standards, every step of our process is built to protect what matters most.
Why Compliance Matters in Reproductive Shipping
Reproductive materials are among the most sensitive biological shipments in the world. Each one must be handled with the highest level of control and care to ensure the safety and viability of the materials being moved. And compliance is as much about confidence in your shipping partner as it is about rules and regulations.
When a logistics partner maintains strong compliance standards, it means that every shipping system, accessory, and process meets verified safety benchmarks. Every shipment is documented and traceable at every step. Every procedure aligns with international best practices for biological transport. In short, compliance is what transforms complex logistics into something families can rely on.
At Cryoport Systems, that’s exactly what we deliver. We have built a framework of safety and accountability that is designed to ensure that your materials arrive safely, securely, and supported at every step.
Setting the Benchmark with ISO 21973 Compliance
ISO 21973:2020 is a global standard that was developed specifically for the transportation of cells intended for therapeutic use. This standard is the most stringent in the world, and while it was developed specifically for cell and gene therapies, Cryoport Systems adheres to these standards across the board, including for reproductive medicine shipments.
This commitment to best-in-class quality and compliance ensures that our systems, processes, and people all meet the highest possible standards for temperature-controlled transport, including in our traceability and documentation. Our personnel are fully trained and exceptionally qualified, and all equipment is requalified and validated to uphold performance standards before every use. Furthermore, proactive risk management and continuous improvement are at the center of everything we do.
This means that when you ship with Cryoport Systems, your reproductive materials are managed under a rigorously audited framework that prioritizes quality and compliance at every turn.
Few companies in the world operate under this level of oversight, and we are the only ones adhering to this standard for reproductive medicine. Cryoport Systems not only adheres to ISO 21973 standards, but we have helped to define what compliance excellence looks like for the entire field of temperature-controlled logistics.
Chain of Compliance® for Total Transparency
Cryoport Systems established a new gold standard in the industry, known as the Chain of Compliance®. This system was built to solve a problem we saw across the market, where too many handoffs and too many unknowns offered too little visibility into what happens between origin and destination. The Chain of Compliance provides a complete, end-to-end record of every component that touches a shipment. This includes:
- Shipping System Qualification: Every shipping system is uniquely identified and performance-tested before every use.
- Calibration Tracking: Equipment maintenance and validation are fully documented and traceable.
- Data Integrity: Each shipment generates digital records of handling conditions, routes, and environmental performance that are maintained for a minimum of 10 years.
This level of track and trace ensures that if there’s ever a question about a shipment, we can trace every variable with complete accuracy. For families, it means peace of mind knowing that their materials are never unaccounted for and are always managed within a trusted system.
Veri-Clean® Ensures the Industry’s Cleanest Shippers
Cleanliness is another safeguard for the future. Our proprietary Veri-Clean process was designed to set a new benchmark for equipment decontamination and validation, and we are the industry’s only provider to fully requalify and Veri-Clean® every shipper, every time. Before any shipping system is released for use, it undergoes a meticulous cleaning process that has been independently validated to remove biological contaminants, including potential pathogens and residues.
Why does this matter? Because the shipping system transporting your materials, regardless of the provider you’re shipping with, has likely been used before. When you choose to ship with Cryoport Systems, it’s as safe and clean as if it were brand new. Veri-Clean eliminates the risks associated with cross-contamination, giving intended parents additional assurance that nothing will compromise their reproductive materials during transport.
Compliance in Action
These standards may sound technical (and they are), but their impact is profoundly human. For intended parents, our robust compliance framework – the most stringent in the industry – ensures consistent safety with every shipment following the same validated process, regardless of destination. It means complete traceability, offering confidence that you know your materials are tracked, logged, and monitored at every step. It offers reliability, with systems that have been purpose-built to minimize risks. And it provides an unmatched level of trust, knowing that your materials are in capable, accountable hands.
Ultimately, compliance is about trust made tangible. It’s what turns an anxious waiting period into confidence that your materials are being handled with the same care you would give them yourself.
Exceeding the Standard, Not Just Meeting It
What sets Cryoport Systems apart is that we don’t stop at compliance… we build on it. Our teams continuously evaluate and refine every process to improve reliability and performance. We work alongside regulatory agencies and our partners to anticipate future standards before they’re mandated. And we apply lessons learned from our work in cell and gene therapy logistics (where compliance expectations are among the highest in the world) to every reproductive shipment we manage.
This commitment to continuous improvement ensures that Cryoport Systems remains at the forefront of safe and compliant reproductive transport so families can focus on what truly matters.
Compliance is often invisible, but it’s the reason every shipment arrives safely (and across all the markets we serve, we’ve safely delivered more than a million of them!). Our industry-leading quality and compliance processes ensure that every shipment entrusted to our care meets the highest standards.
We are proud to lead the industry in compliance excellence so every family we serve can move forward with confidence, knowing their materials are protected by the most advanced safeguards in the world.
