Chronicled, Inc. has announced that its second-generation micro temp- logging solution has been certified for Title 21 CFR Part 11, which is a U.S. Food and Drug Administration regulatory framework for the management and storage of electronic records and signatures.  This approval paves the way for Chronicled to assume a leadership position in providing its Temperature Loggers to businesses distributing sensitive, cold chain products across the United States and overseas.

21 CFR Part 11 “defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.” The law requires FDA-regulated industries to implement controls that are capable of audits, validation, and digital signing and to provide documentation demonstrating that standard operating procedures and change management procedures are maintained.  With this certification complete, the Chronicled temperature monitoring solution is now ready for mainstream application in the highly regulated pharmaceutical cold chain environment.

The term cold chain, or temperature controlled logistics, refers to a temperature-sensitive supply chain, in which the products being shipped must be maintained within a specific temperature range.  The integrity of the cold chain is crucial to multiple sectors including pharmaceuticals, biologics, vaccines, as well as others. If, for example, a pharmaceutical product exceeds its temperature limits, in what is known as a temperature excursion, the quality and efficacy of the drug can be severely impacted.  The result of a drug becoming adulterated by excessive temperatures can create pharmaceutical supply interruptions, and more importantly can impact the health and safety of many patients.

Since supply chains involve numerous independent custodians who are responsible for a product during a portion of its journey, it is essential to have a resilient, transparent, and trustworthy system for verifying that appropriate temperatures have been continuously maintained.

Chronicled’s second-generation micro temp-logger combines Near Field Communication (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.  This data storage method, in which each data point is recorded on-chain within an immutable “block”, makes the product’s temperature history 100% secure and untamperable.  As a result, regulators and end-customers no longer need to worry about edited, modified, or deleted records in the event of an investigation.

“This milestone is yet another step forward towards our vision of smart supply chain solutions with integrated IoT, AI, and blockchain technologies,” said Chronicled CEO Ryan Orr.

“We’re seeing a lot of interest in our solution from major pharmaceutical companies, biotech manufacturers, and third-party logistics players, and I think that’s only going to increase with this certification,” said vice president of Healthcare Sales, Ross Blum.  “The combination of our competitive price point, innovative hardware, and ultra-secure data back end makes us a very attractive option to the life science market.”