SAN FRANCISCO, Dec. 11, 2017 /PRNewswire/ -- Chronicled, Inc. announced today that its second-generation micro-sized 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-sized 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.
"We're extremely gratified to achieve 21 CFR Part 11 certification," said Chronicled CEO Ryan Orr. "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."
"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 VP 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." Chronicled is currently taking commercial orders for the temperature logging system. Completion of 21 CFR Part 11 certification readies the company to assume market leadership in cold chain compliance.
"With this certification, Chronicled's temperature data logger delivers an unrivalled product that combines a sensor with near field communication (NFC) and secure cloud software. We are thrilled that Chronicled's software leverages Identiv's NFC inlay technology and its associated security model," said Stephane Ardiley, Identiv Director of Product Management. "Since Identiv began working on intelligent NFC devices, we have focused on delivering a trusted model for Internet of Things (IoT) applications — this accreditation is the result of that. We congratulate the Chronicled team on this major achievement to deliver a comprehensive sensor solution that meets the most stringent FDA requirements."
About Chronicled Based in the innovation hub of Silicon Valley, Chronicled is a technology company leveraging blockchain and IoT to power smart, secure supply chain solutions. Chronicled offers a Blockchain-based Smart Supply Chain Platform and secures IoT device identities, data, and event logs and automates IoT-dependent business logic using smart contracts. Chronicled is also a founding member of the Trusted IoT Alliance, with the mission of creating open source tools and standards to connect IoT and blockchain ecosystems to deliver business value.