April 2019 - rfxcel.com

rfxcel Supports ANVISA SNCM for Safer, Traceable Medicines

Reno, NV April 29, 2019— rfxcel, the leader in track and trace solutions for the pharmaceutical market, announces its support for ANVISA’s SNCM medicine traceability system. ANVISA announced that the 3 years deadline to be compliant with the system starts today. rfxcel has a team in place and is ready to support customers immediately.

The National System for the Control of Medicines (SNCM), founded by Law No. 11,903 of January 14, 2009, establishes mechanisms and procedures for drug tracking & tracing, through technology for capturing, storing and transmitting data electronically throughout the supply chain of pharmaceuticals in the national territory (Brazil).

By April 2022 all members of the supply chain must be able to capture, store and exchange data electronically regarding prescription drugs. rfxcel has applied its more than fifteen years of traceability expertise and it is ready to support the industry to be compliant in Brazil.

Vinicius Bagnarolli, Director of Operations LATAM, rfxcel, comments: ‘’This is a great step for Brazil to protect its citizens against counterfeit pharmaceuticals and cargo theft. Europe and the United States have similar laws that have been implemented successfully. Brazil is the biggest economy in LATAM and among the biggest in the world therefore the SNCM should be celebrated  as a statement of intent that Brazil’s drug industry will follow global quality trends.’’

Mark Davison, VP of International Business, rfxcel, comments: Organizations in the medicine supply chain urgently need clarity and support from experienced solution providers with traceability expertise. We’ve been working with customers in Brazil for some time. The SNCM is challenging, but rfxcel builds these requirements into existing business workflows to give a great opportunity to improve patient safety and supply chain efficiency.”

As the pioneer and a leader of track and trace solutions for the Life Sciences industry, rfxcel provides a robust technology platform as well as a full-service implementation/support model, that ensures customer success, patient safety and peace of mind.

“Pharma to Table”: What Food Can Learn from Pharma Unit-Level Traceability




“Pharma to Table”: What Food Can Learn from Pharma Unit-Level Traceability 

In partnership with METTLER TOLEDO (MT). MT is a leading global manufacturer of precision instruments and services for use in laboratories and manufacturing.

Please join rfxcel and Mettler Toledo for “Pharma to Table”: What Food Can Learn from Pharma Unit-Level Traceability. During this 45 minutes long presentation, our panelists, represented by both organizations, will discuss the following:

  • The Current State of the Food/Beverage Marketplace
  • What is Serialization & What Does It Do?
  • What Knowledge Can Food/Beverage Gain from the Pharmaceutical Industry
  • Best Practices/Lessons Learned 

We will allow 15 minutes at the end of the presentation, for a Q/A session. We encourage you to register even if you are unable to attend at the scheduled date/time. All approved registrants will receive a recorded copy of the webinar presentation.

**This webinar is intended for educational purposes for those inside the Food/Beverage Industry. Service Providers and Consultants can request to join by sending a separate email to rfxwebinars@rfxcel.com. At this time, rfxcel does have the right to exercise refusal into this webinar presentation.**


The Future of Food Safety Is Serialization

The Food Safety Modernization Act wants companies to proactively mitigate risk. Unit-level traceability is the logical next step

Leafy green producers had a terrible 2018.

According to the Centers for Disease Control and Prevention (CDC), E. coli outbreaks linked to romaine lettuce infected 272 people in 39 states and the District of Columbia; of these, 121 were hospitalized and 5 died.1 Outbreaks linked to romaine from the same growing area also occurred in Canada. There was one recall, and both countries issued an advisory for all romaine.

Apart from the human toll, the cost of recalls can be staggering. A 2012 study by the Grocery Manufacturers Association (GMA) and the Food Marketing Institute concluded that the average direct cost of a recall in the United States was $10 million. In a separate study, GMA reported that 18 percent of surveyed multinational corporations had spent $30-$90 million on a single recall, and 5 percent had been involved in recalls with price tags topping $100 million.

Factor in indirect costs such as legal fees and damage to brand reputations and product categories — even entire industries — and it’s easy to see that recalls are a major problem.

During the romaine outbreak, Dr. Bob Whitaker, chief scientific officer at the Produce Marketing Association, advised the leafy greens industry to “ready traceback data.” This was an admission that the food industry had a long way to go to meet the demands of the modern supply chain, where accurate, granular, real-time product data is essential for mitigating emergencies and remaining competitive.

End-to-end, serialized, unit-level traceability is now the standard in the life sciences industry, where, like the food industry, a product’s purity and authenticity can be a matter of life and death. Similarly, serialization has the potential to increase the speed and accuracy of food safety investigations while reducing the scope and cost of recalls and product withdrawals.

Today, we can imagine a world where each bag of lettuce mixes or clamshell of berries has a unique identifier that can be tracked and traced from the exact picker and harvest plot through packing, casing, and palletizing, then on through distribution and retail — all the way to the consumer.

We can also envision empowering consumers to know everything about the pedigree of the exact item in their hand. What if they could scan your item at the store to ensure that it isn’t involved in a recall? What if you could message them after they took it home? What if you could tell them the item they’re holding had been scanned for foreign objects or tested for contamination that same day?

At last year’s Food Safety Consortium in Chicago, representatives from the CDC and U.S. Food and Drug Administration, presented on 2018’s first romaine outbreak, which began in April and appeared to be over by late June. As reported by Food Safety Tech, they identified several challenges, including:

  • The production lot information disappears at the point of service.
  • Having a commingled product hinders traceback.
  • It takes time for authorities to review companies’ records.
  • Packaging isn’t transparent about where the product was grown.

Let’s walk through a scenario in which people report getting sick after eating romaine lettuce from packs they purchased at a retail store. With serialization, the chain of events could look like this:

  • Consumers who feel sick can report the package’s serial number by phone or perhaps through a link, sent by the retailer, that reads a 2D barcode and transmits the package’s unique number.
  • All products from that harvest plot are immediately flagged, as the traceback goes all the way to the pickers/plots, then forward again to the actual items on the shelf — not just to a distribution center.
  • With rich data from serialization, we know which items from the case are on the shelf and which are still in the case.
  • As more data becomes available, authorities can pinpoint the issue, and only affected items are pulled from the shelf.

The benefits of serialization are great and costs are coming down. Consumers are interacting more with brands and expecting more data about products. Recognizing these realities — and in the ever-present context of the Food Safety Modernization Act — food companies should be looking to serialization and unit-level traceability to provide the data to safeguard their operations and thrive in the marketplace, today and in the future.

1See CDC information from June 28, 2018, and January 9, 2019.

Orders of Magnitude: What Does Serialization Mean for the Food Supply Chain?

Serialization has transformed pharma. Food and beverage is next.

The pharmaceutical industry, spurred by global regulatory demands, has begun to transform itself by adopting unit-level traceability through serialization.

It has also responded to the ever-present threats of fraud, adulteration, and counterfeiting by working to make the supply chain a tightly controlled, transparent system. And, importantly, companies have begun to use the richer, timelier data that serialization creates to gain competitive advantages and increase market share.

The food industry is at a different type of crossroads, but it may lead to the same place. Innovative leaders are beginning to see serialization as a key tool to mitigate risk and drive growth; they are realizing that it empowers real-time track and trace and authentication, targeted product recalls, personalized marketing, and other critical operations.

But what is serialization, exactly? Simply put, it’s the process of creating a unique identifier or code for every item you sell, a package-level ID that can add up to four orders of magnitude (lot/batch, pallet, case, item) to your supply chain visibility in a single step. With serialization, each production batch is transformed from a jumble undifferentiated packs to individual, traceable units that have quality metrics and event attributes associated with their data. This data, from harvest information to each item’s unique journey to the consumer, is transparent and specific, not opaque and broad, which amplifies its power for decision-making, quality assurance, and a host of other uses.

The automotive industry, an early adopter of serialization, provides a nice analogy. Think of your car’s vehicle identification number (VIN). It is unique and trackable. When you buy a used car, you don’t use the VIN to learn about Ford Explorers generally; you use it to find out about the exact car you’re looking at — its history, its real-time condition, and so on.

This is the power of serialization. Knowing the unique story of the very item you’re holding in your hand. The idea that this clamshell of strawberries or container of tomatoes or can of soda may have a different story than the one next to it, even if they look identical.

In a lot-based system, the lot code provides only limited data. All the pallets, cases, and units share the same basic information, even if there are crucial differences among the individual items, such as the provenance of ingredients or harvest dates.

Product tracking can begin to fall apart as soon as shipments arrive at a distribution center. Pallets can be re-routed and cases can be disassembled and re-packed before units are shipped to fulfill orders.

With serialization, each input or movement can be recorded. When individual units are serialized, so are the case and pallet. Scanning the case or pallet provides data for all units inside and allows proper tracking as that case is assembled and disassembled. That’s how end-to-end traceability happens.

By tracking this “parent-child” relationship between pallet and case, and case and unit, it suddenly becomes possible to deal with challenging logistics, such as just-in-time inventory and targeted recalls.

The marketplace is inundated with providers who want to sell you vendor management software disguised as a traceability solution. Don’t be fooled. To deliver on current, emerging, and future demands, you must have granular, actionable data that you can access in real time. This kind of data is much more powerful than what most companies rely on today to protect their business.

Alas, despite the incredible — and demonstrable — value of serialization, many believe cost is a barrier to adoption. The truth, however, is that stringent pharma regulations in the United States, EU, and elsewhere are driving innovation, making serialization technology more affordable and reliable.

Furthermore, many forward-thinking food companies already have many of the pieces in place to take the next step. These include line systems, enterprise resource planning (ERP) software, and warehouse management systems (WMS), which make operations more accurate and efficient, and are the foundation upon which truly transformative change can be built.

Serialization is the essential step toward a modern supply chain. It can help ensure you are protected now and prepared for future challenges, from changes in regulation to an unexpected recall. Instead of playing catch-up tomorrow, the wise company will consider serialization today.