Frequentz, a company in the ePedigree and track-and-trace space, expects the food traceability industry to see rapid growth in the next several years to ensure consumer safety and helping to prevent recalls. Frequentz recently formed a Steering Committee to help customers in the pharmaceutical industry begin taking steps to comply with the Data Quality and Security Act (DQSA), which will impact product packaging and labeling.
In this Packaging Digest exclusive, Frequentz founder and president Michael Lucas shares his views of where things are headed at the consumer safety confluence of food, drugs and technology.
Briefly describe IRIS.
Lucas: Frequentz's Information Repository & Intelligence Server (IRIS) is an event-driven traceability server that provides organizations (manufacturers, distributors, suppliers, retailers and government agencies) complete visibility across the lifecycle of a product. Combining Frequentz's data traceability technology with IBM's InfoSphere Traceability Server, acquired by Frequentz in November 2012, IRIS is a comprehensive and scalable track-and-trace technology.
Why and how was IRIS developed?
Lucas: IRIS was developed to bring visibility to the supply chain and create true end-to-end supply chain security and authenticity across verticals including pharmaceutical / life sciences, agricultural, seafood, industrial (aerospace, automotive, chemical) and retail industries. Subsequently, IRIS satisfies the industry's need for serialization and traceability solutions that track, trace and store all information around product development and supply chain logistics in a central, data repository.
IRIS addresses the market need for technology that provides greater visibility into the product supply chain. These needs are driven by regulations, business needs, quality assurance, customer engagement, health and safety. For example, in the agricultural industry, Frequentz can track food from farm-to-fork. In the event of a product recall, having IRIS allows food manufacturers to significantly initiate a targeted recall, which in turn reduces the time it takes to remove the product and contact the customer or retailer. Consequently, reducing risk of consumer exposure and containing the potential brand erosion.
Furthermore, IRIS provides consumers and retailers with a safeguard: product authentication and assurance that if there is a problem there is a process and technology in place that seeks to protect the consumer and minimize health and safety risks.
Whether leveraging IRIS technology for the purposes of gaining greater visibility, tracking food from farm-to-fork or reducing risk of exposure, IRIS provides clients real-time access to the complete life history and quality assurance of a product from manufacturing, through distribution to point-of-purchase. This capability is critical in the event of a product recall or suspected fraud and counterfeiting.
Specific competitive advantages include, but are not limited to: The solution is ERP (Enterprise Resource Planning) agnostic; aims to solve issues in trading globally by adhering to international standards; serves multiple verticals allowing the technology to take from best practices offered in each; can be offered in two forms: onsite or in the cloud; and supports the evolution to EPC Information Services (EPCIS) from Drug Pedigree Messaging Standard (DPMS).
Why is the timing good for this solution?
Lucas: Fragmented nature of globalization, the vast size and complex nature of suppliers and the supply chain, international trade and commerce and customer demand has driven the adoption of traceability. Furthermore, the increased prevalence of seafood fraud and concerns around sustainability also driven the adoption and need for traceability. Regulatory bodies have developed policies that mandate authentication and traceability as key approaches to ensuring safety and health and reducing risks, like, for example, the Drug Quality and Security Act (DQSA) in the pharmaceutical industry. The recent passing of DQSA by the US Senate is a critical and necessary move for large U.S. drug compounders to eliminate drug mislabeling and counterfeit. The traceability legislation raises U.S. standards for drug compounding compliance to improve consumer safety.
The US lags in the development of traceability regulations vis-à-vis vital economic regions where laws and regulations have already been piloted, if not fully executed abroad, mainly in the European Union.
What’s going on with the Steering Committee?
Frequentz has established a Steering Committee of IRIS-installed customers to collaboratively and proactively work to understand DQSA and anticipate future roll out needs and concerns. The goal of this committee is to help support customer compliance with, and implementation of, requirements from DQSA.
What can be shared about the 2014 RxTrace Survey Results?
Lucas: Sponsored by Frequentz, the 2014 RxTrace “US Pharma Traceability Survey” reveals industry perspectives on DQSA.
Enacted in November 2013, the Drug Supply Chain Security Act (DSCSA), which is embedded in DQSA, created new federal track-and-trace requirements for the pharmaceutical supply chain and preempted all state and federal serialization and pedigree laws. RxTrace, a media outlet focused on traceability and the pharmaceutical supply chain, surveyed 78 executives working in, or targeting, the pharmaceutical supply chain to gauge their opinion and state of readiness to comply with the federal mandates
Key findings of the survey revealed:
- Most companies will treat the DSCSA and thus DQSA with the same or more urgency and interest than they treated the California pedigree law;
- While most people believe their company leaders understand all or most of what will be required to meet the requirements, uncertainty still exists in many of the definitions of what is required;
- Most people agree that EPCIS will be the future technology agreed upon to pass transaction information.
While the survey shows that there is a high level of confidence that most manufacturers will eventually comply to the regulations, it’s clear there remains different interpretations and definitions by respondents. Meanwhile, what is certain is that there is a date by which to comply looming. Through the Steering Committee, Frequentz helps partners into making timely and efficient decisions in order to meet the requirements.