Unclonable Authentication for Patient Safety and Traceability
A new approach to pharmaceutical product authentication, validated in real production environments.
An O-KEY is a physical, AI-verified product authentication technology enabling reliable anti-counterfeiting, traceability, and regulatory compliance at unit level.
Counterfeit and diverted medicines remain a serious risk to patient safety and public trust. While serialization is now standard, most identifiers were built for logistics, not for security. Codes can be copied, substituted, or degraded over time, leaving gaps where falsified products can enter the supply chain.
O-KEY addresses this gap by giving every pharmaceutical product a unique physical identity that cannot be copied or reproduced. Each O-KEY is verified using artificial intelligence and linked to controlled product data. Following a major grant from Innovation Fund Denmark and collaboration with Novo Nordisk and the University of Copenhagen, the O-KEY solution is now being optimized specifically for pharmaceutical use.
Built for Pharmaceutical Production and Regulation
An O-KEY is applied directly to the product as a label or integrated surface mark. The physical signature consists of thousands of microscopic features that form a unique pattern. This pattern is recorded at production and later authenticated through image-based AI verification. The result is a clear yes or no answer, delivered through a standard smartphone or dedicated scanner.
As part of the funded development program, the O-KEY is being adapted for cleanroom environments, medical-grade materials, and high-speed scanning. The work includes progress toward USP Class VI material certification and alignment with EU Unique Device Identification requirements. The objective is straightforward: make product authentication reliable, practical, and compliant in real pharmaceutical manufacturing conditions.
A Practical Layer for Compliance, Traceability, and Patient Safety
Beyond authentication, an O-KEY functions as a secure link between each physical product and its digital record. Pharmaceutical companies can use O-KEY to:
- Verify authenticity anywhere in the supply chain
- Trace individual units across distribution and use
- Support recalls with precise, unit-level data
- Provide access to digital instructions or safety information
- Document chain of custody for regulatory or legal review
Implementation is designed to be low-friction. Label-based solutions can be deployed within weeks and integrated into existing IT and quality systems without interrupting production. This allows teams to validate value quickly before scaling.
Discover more
From high-end fashion to electronics, our O—KEY ensures that every product is genuine, safeguarding your brand and consumer trust. Find out how our advanced, yet simple technology fits your industry’s unique challenges and needs.
Limits of QR codes
The O-KEY technology overcomes the limits of QR codes
Shortcomings of RFID and NFC
The O-KEY technology overcomes RFID and NFC
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