Committed to Quality

CSafe supports compliance with our continued emphasis on quality procedures and safety measures. Through our dedicated quality team, we are focused on achieving the necessary certifications, supporting the thermal qualifications required and providing necessary documentation with our robust Quality Management Systems (QMS). We follow the process so you can meet applicable governmental and regulatory requirements when shipping life-saving medication.

Certifications

CSafe works in conjunction with governmental and regulatory bodies to ensure qualification standards, quality requirements and operational needs are met through the following certifications:

Pharma

Food and Drug:
- United States Food and Drug Administration (FDA) 21 CFR Part 820
- Accord Transport Perishables (ATP)
ISO 9001- Quality System (Global Standard)
ISO 14001 – Environmental (US, UK, India, LATAM)
ISO 45001 – Health and Safety (US, UK, & India)
ISO 13485 – Medical Device (US)
MDR – CE Medical Device Requirement

Airlines

Part 145
- Federal Aviation Administration (FAA)
- European Union Aviation Safety Agency (EASA)
Part 21:
- Federal Aviation Administration (FAA)

Qualification

With CSafe’s temperature-controlled shipping solutions, cold chain confidence comes standard through our extensive qualification process. CSafe supports Design Qualification (DQ), Operational Qualification (OQ) and Performance Qualification (PQ) for our portfolio of solutions, ensuring that your payload will always be protected from the demands of global transport:

Long shipment durations
Extreme ambient temperatures and wide temperature swings
Remote point-of-use destinations with limited experience
Extended periods without available grid power
Harsh handling

Our comprehensive testing protocols leverage state-of-the-art environmental ISTA- certified test chambers, advanced data-acquisition systems, and sophisticated control software to confirm internal payload temperatures under widely varying ambient conditions. All equipment is calibrated on a regular basis using National Institute of Standards and Technology (NIST)-traceable instruments.

Quality Management Systems

CSafe adheres to all applicable government and regulatory standards to ensure our customers enjoy peace of mind with our industry leading products in performance, processes and quality. The Quality Management Systems of our products are separated into two general systems, Airlines adhering to FAA and EASA standards and Pharma with an ISO 9001 base for all systems, with additional regulations and standards added based on geographic location and product stream. We are heavily audited by governments, regulatory bodies and customers to ensure our systems are compliant and performing at a world class standard.

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