Chronicled blockchain-based temperature logger FDA-approved for supply chain use
Chronicled Inc., provider of a blockchain-based smart supply chain platform, has announced that its second-generation micro-size temp logging solution has been certified for Title 21 CFR Part 11, a U.S. Food and Drug Administration regulatory framework for the management and storage of electronic records and signatures.
According to a company press release, approval paves the way for Chronicled to provide its temperature loggers to businesses that distribute sensitive, cold chain products across the United States and overseas.
The term cold chain — or temperature-controlled logistics — refers to a temperature-sensitive supply chain in which the products must be maintained within a specific temperature range. The integrity of the cold chain is crucial to sectors such as pharmaceuticals, biologics, vaccines and others.
The second-generation Chronicled micro-size temp logger combines NFC hardware with a secure cloud-based service, or optional blockchain back end, to ensure the highest level of data integrity currently available in the market.
With this certification complete, the Chronicled temperature monitoring solution is now ready for mainstream application in the highly regulated pharmaceutical cold chain environment, the release said.
"We're extremely gratified to achieve 21 CFR Part 11 certification," Chronicled CEO Ryan Orr said in the release. "Our team has worked diligently and demonstrated the highest levels of software development capability. This milestone is yet another step forward towards our vision of smart supply chain solutions with integrated IoT, AI, and blockchain technologies."