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DSCSA ATPs: Top Authorized Trading Partner Questions, Answered

What’s being discussed to ensure interoperability of different credentialing solutions for authorized trading partners (ATPs)? Is GS1 going to set standards for ATP credentialing solutions? If a solution provider supports DSCSA compliance and customers will aggregate serial numbers, why do users need to do anything else? 

These were the Top 3questions from “Authorized Trading Partners: The OCI Solution,the third and final presentation in the “DSCSA 2023” webinar series we hosted last month. rfxcel Global Executive Advisor Brian Files was hosting that day, and we share his answers below.

We also shared our answers to the top questions from the two other webinars, The Verification Router Service: Aligning to the Standardand ASN to EPCIS: Industry Change, Your Challenge.” There’s a lot of good information there, so be sure to check them out!

Our “DSCSA 2023” webinars were part of our ongoing efforts to keep the pharma industry updated about the DSCSA and help all stakeholders be ready for the full serialization of the U.S. pharma supply chain in November 2023. If you have other questions or want more details about DSCSA 2023, contact us today. You can also watch the webinars and download the presentation slides here.

What’s being discussed to ensure interoperability of different ATP credentialing solutions?

The same industry stakeholders are involved in developing the different solutions, whether it’s the Open Credentialing Initiative (OCI), .MED, or XATP. It’s important to have systems that connect and exchange information. The HDA has been hosting meetings with the three ATP providers to determine how/if interoperability can be achieved. Great progress has been made in a short time but there are still many open issues to be resolved as of mid-July 2021.

Is GS1 going to set standards for ATP credentialing solutions?

GS1 is not setting the standards; however, as part of the HDA effort to ensure interoperability, the teams are keeping GS1 updated on their efforts to ensure any GS1 specifications are updated/clarified as needed. For example, ATP will leverage the VRS messaging standards, which may need to be updated/clarified to include ATP.

If a solution provider supports DSCSA compliance and customers will aggregate serial numbers, why do users need to do anything else? 

For DSCSA 2023, the onus is on companies to ensure they’re getting their data in the proper format. Just having a DSCSA solution will not make you compliant. You have to go through your operational protocols and procedures and design your internal systems so they’ll be DSCSA-compliant.

Some companies have been working with solution providers since the early days of the DSCSA rollout, but have yet to optimize how their compliance software works with their internal systems, how they work with their provider, and, critically, how they communicate with their trading partners. Companies need to optimize internally to get the most out of their solutions — and to ensure compliance.

More DSCSA 2023 resources from rfxcel

Supply Chain Traceability Systems Make Your Business Better

One of the best ways to get more people to buy your products is to inspire consumer confidence. And one of the best ways to increase consumer confidence is to insist on airtight food safety protocols, which absolutely should include supply chain traceability systems.

Are there some areas where your food safety can improve? It’s always a good idea to periodically reflect on what you and your team are doing. This will allow you to improve on weak spots in your food supply chain. Supply chain traceability systems are a huge help.

Most important, the ability to trace everything in your supply chain ensures you are delivering safe food to your customers — and building consumer confidence. It also helps ensure compliance with regulations. So, if you don’t have traceability in your supply chain, you should consider implementing a system as soon as possible.

Let’s take a closer look at the benefits supply chain traceability systems can bring to your business.

What are supply chain traceability systems?

Supply chain traceability systems are a powerful tool for any industry. They give you the ability to know where your ingredients and finished products have been and where they’re going as they move through your supply chain, through the “life cycle” of your business. They are particularly helpful with maintaining product safety and minimizing and proactively managing issues that could harm your business, such as a recall.

Advantages of supply chain traceability

There’s no doubt supply chain traceability systems will save your company time, money, and effort. But what specifically can they do for you? Let’s look further into the benefits of implementing a food safety program with supply chain traceability.

Effective recall management

Supply chain traceability is a key part of recall management. The food industry is one of the most vulnerable to recalls. A recent example is Tyson Chicken. On July 3, 2021, the food giant had to recall almost 9 million pounds of ready-to-eat chicken in the United States. Thanks to supply chain traceability, however, Tyson could work quickly and effectively with the U.S. Department of Agriculture, pinpointing when the products were made and what labels were on the packaging, notifying consumers, and mitigating further troubles.

Needless to say, a recall of any size can hurt profitability and brand reputation. But supply chain traceability systems help manage damage. As we’ve discussed before, having the proper systems in place for effective recall management is paramount for protecting your business’ profitability and your brand reputation.

Regulatory compliance

Another advantage of implementing supply chain traceability systems is meeting regulatory requirements. The FDA keeps a watchful eye over food supply chain processes in the United States. And, with much of our food traveling far and wide before it reaches our plates, those processes require many moving parts. Being aware of where your food has been, where it is now, where it’s going, who is handling it, and how long it’s been in transit are all helpful metrics to keep your operation in compliance with the FDA and other regulatory agencies.

The FDA is pushing hard for more traceability standards, and consumers are more aware of where their food is coming from and demanding more information about what they eat. This is yet another reason why traceability is so important today.

Maximized efficiency

Being able to trace (and track) your products as they move through your supply chain also allows you to identify inefficiencies and bottlenecks. In other words, end-to-end traceability maximizes operational efficiency. It will enable you to see which processes are working well and which ones aren’t.

Supply chain traceability systems also help you cut costs. If you have rich data that quantifies that a particular process (or trading partner) is inefficient, you can take steps to improve it or remove it from your supply chain process.

Consumer engagement

Believe it or not, traceability will also help your sales. Customers love stories — and they’re demanding more information about the products they buy. Smart companies will use their supply chain traceability systems as part of their marketing, connecting with consumers by telling their story and sharing information about their products.

You see this all of the time in the food industry. In commercials, companies highlight how far their products have traveled and how much care goes into making, packaging, and shipping them. This kind of advertising paints a picture of the journey the products take to arrive in a customer’s home and emphasizes the qualities people want (e.g., salmon from Alaska or peaches from Georgia). Being able to “play up” the source and the journey will make your food products more appealing to shoppers.

Communicating with stakeholders

You always need to consider input from stakeholders. Supply chain traceability is an effective way to keep them happy. Making stakeholders aware of this information is known as supply chain transparency.

Supply chain transparency is an important part of your business. While food safety and quality are important, you also need to keep your trading partners in the loop. Any effective supply chain transparency plan has three main components.

The first component is the “what” of your supply chain traceability. What information are you going to share with your stakeholders? You’re also going to want to determine what format you’re going to use to display the information.

The next step is to decide the “who. Who needs to see this information? Several different groups might need it, such as internal stakeholders, vendors, suppliers, clients, and consumers. You’ll also want to consider why they need to have it.

Last, you’ll want to consider the “when. When are your people going to get this information? And how often?

You’ll also need to decide how often to update your information. Today, the trend is toward real-time updates. This is the ideal scenario, but it can be a challenge to attain. Supply chains involve a lot of moving parts and have many different nodes or tiers. Providing real-time updates in this complex framework requires efficient, streamlined operations utilizing supply chain traceability systems.

Supply chain mapping

Supply chain mapping — the process of mapping every tier of your supply chain with easy-to-follow imagery — is an effective way to keep all your stakeholders happy. A supply chain map doesn’t show every person involved in the process; instead, it shows all of the players within each tier of the supply chain.

One of the benefits of supply chain mapping is that it presents an opportunity for risk assessment. Seeing your supply chain clearly mapped out allows your management team to decide which areas need to be carefully monitored. You can also analyze your supply chain with a “bird’s-eye view” and decide if you need to make adjustments for greater efficiency.

Safer, healthier food

Today, grocery stores are full of food that’s touted as being locally sourced, sustainably caught, and so on. How can companies make and prove these claims? With end-to-end supply chain traceability data. Making these types of claims requires companies to make sure they are tracking the right metrics to support them. Companies also need to leverage the correct technology to support these initiatives.

Examples of how supply chain traceability systems work

How do companies achieve end-to-end supply chain traceability? Keeping track of your products and all the important metrics requires modern technology.

One of the ways companies are doing this is by putting QR codes and 2D Data Matrix codes on their packaging. These codes contain important information and can be scanned as products move through the supply chain. This allows vendors, suppliers, and people responsible for transport to “check the food in” at various points throughout the process and add important data, including critical tracking events (CTEs) and key data elements (KDEs).

Leveraging this technology is a critical aspect of today’s supply chain traceability systems. It helps companies keep track of where their products are at all times, throughout all nodes of the supply chain. For more information about it all works, download our new white paper, Traceability in the Food Supply Chain.

A quick word about blockchain

As technology moves forward, supply chain traceability systems also continue to evolve. One of the newest technologies with traceability applications is blockchain.

Most people probably associate blockchain with cryptocurrencies such as Bitcoin. One of the reasons Bitcoin is so valuable is because it can be traced across the internet via the blockchain. Investors and computer programmers can map each Bitcoin to its proper place on a global digital ledger.

This and other characteristics give blockchain tremendous functionality in a wide array of industries. For food in particular, blockchain can help companies achieve a “locked down” supply chain, providing indisputable, verified data and a level of security not possible with other technologies.

What do you think tracking food products in the same manner as cryptocurrency would do for supply chain traceability systems? It’s still in the early stages, but blockchain could revolutionize traceability. It’s a complicated subject, so we encourage you to download our white paper, Blockchain-Based Supply Chain Traceability.

Final thoughts

Supply chain traceability systems are an essential part of any business. But they’re especially important in the food industry. The safety and quality of your product is the most important part of your business. Consumers’ health depends on it. Your brand reputation depends on it. Your bottom line depends on it.

rfxcel can help. We have the software solutions you need for your business — for supply chain traceability, regulatory compliance, serialization, monitoring, and even vaccine track and trace.

Contact us today if you have any questions about supply chain traceability systems or would like to see a short demo of how our solutions can help you build your business, no matter what your business is.

 

DSCSA 2023: Top EPCIS Questions, Answered

When will companies start sending EPCIS? If a solution provider supports DSCSA compliance, why do users need to do anything other than ensure their products are aggregated? 

These were among the questions people asked at our second “DSCSA 2023” webinar last month, “ASN to EPCIS: Industry Change, Your Challenge.Herb Wong, rfxcel VP of Marketing and Strategic Initiatives, was the host, and we share his answers to the most-asked questions below.

Check back tomorrow, because we’ll be posting the top questions from the third and final webinar in the series, “Authorized Trading Partners: The OCI Solution.” You can also read our answers to the top questions from the first webinar, The Verification Router Service: Aligning to the Standard.

If you have other questions or want more details about DSCSA 2023, contact us today. Oh, and you can watch the entire “DSCSA 2023” webinar series and download the presentation slides here.

When will companies start sending EPCIS?

It has already started. However, the industry hasn’t achieved the volume it will need for 2023 (or right now, for that matter). There aren’t exact figures of the current volume of returns supply chain stakeholders (e.g., manufactures and wholesale distributors) are generating, but we do have anecdotal information from one of the Big 3 that they’re getting only about 10 percent. That data is a few months old, though, and that number could have increased. But overall, the industry needs to continue boosting the volume.

If a solution provider supports DSCSA compliance and industry (e.g., HDA) requirements, why do users need to do anything other than ensure their products are aggregated? 

A DSCSA solution should ensure you’re compliant and adhering to industry standards. But there’s more to it than that. For example, a solution provider needs permission from a manufacturer to send its serialized data; however, some manufacturers have chosen not to send this data, even though they have the means to do so. Right now, it’s important to be sending this data so solution providers can continue to work with the industry to ensure that all the data entering the system is clean and the VRS is working well.

So, it’s not that a solution provider can’t handle this for you. The issue is that providers need their customers to agree to send the information and communicate with their trading partners to make sure everyone’s on the same page. This needs to occur throughout the supply chain (e.g., as manufacturers send data to wholesale distributors and wholesale distributors send data to dispensers). Also, dispensers need to be able to receive the data. It’s all about communication and coordination.

What is the vision for the Center of Excellence? Will membership be open to everyone in the industry at no cost, or will membership be limited to certain organizations?

The current vision is that there will be no fees. The intention is to facilitate broader coordination among all participants to encourage data to flow through the system and to build an optimal method for resolving issues. As for membership, the reality is there has to be coordination with certain groups, because it will be difficult to succeed without some sort of organization to “rally around.” In all likelihood, the Center of Excellence will probably be coordinated through the Healthcare Distribution Alliance (HDA). But even if you’re not an HDA member, that shouldn’t preclude you from participating.

What about transformation of events of inbound to outbound serial numbers for 2023 requirements?

Here, “transformation” means, for example, sending a pallet to a wholesale distributor who then “transforms” it by opening a case and sending individual products downstream (e.g., to a dispenser). The vision is to have each entity that transforms — unpacks and repacks — products to manage that process inside their own organization. The role of EPCIS is to handle the actual communication of every transformation. It’s important for the industry to understand and be able to verify every transformation event, and EPCIS is the tool that makes this possible.

In terms of repackaging, an example would be if a company puts different medicines (with different SKUs) together in a new configuration, or package, that meets a certain need (e.g., a combination of pills to treat a specific condition). In that process, the repackager must issue a new serial number that would have to be DSCSA-compliant in terms of EPCIS data flow.

These are the kinds of scenarios the industry needs to flesh out and be ready for by 2023.

More DSCSA 2023 resources from rfxcel

DSCSA VRS: Top Verification Router Service Questions, Answered

When do I need to implement the DSCSA VRS? Are there any new developments the industry should be aware of? What are some of the “sticking points” with the VRS today?

These were just a few of the questions asked during the first of three “DSCSA 2023” webinars that we held last month. In “The Verification Router Service: Aligning to the Standard,rfxcel VP of Marketing and Strategic Initiatives Herb Wong and Global Executive Advisor Brian Files answered these and other questions about the DSCSA VRS. Below, we give their answers to the most-asked questions.

Check back throughout the week, because we’ll be posting the top questions from the other two webinars in the series, “ASN to EPCIS: Industry Change, Your Challenge” and “Authorized Trading Partners: The OCI Solution.

The webinars were part of our ongoing efforts to keep pharma stakeholders up to date with the DSCSA and help the industry prepare for the full serialization of the U.S. pharma supply chain in November 2023. If you have other questions or want more details about DSCSA 2023, contact us today. You can also watch the webinars and download the presentation slides here.

When do I need to implement the DSCSA VRS?

Manufacturers and wholesalers/distributors should be implementing right now. VRS is a cornerstone of the DSCSA; it’s not going away. As you go through the 2020 to 2023 period, working with your partners is going to be critical. You should also be working with your solution provider — or finding one if you don’t already have one. Keep your eyes on the November 27, 2023, deadline and always be working toward it so you’ll be ready and compliant. Dispensers should be looking carefully at the benefits of VRS and requirements for validating saleable returns. (See response to next question.)

Are there any new developments the industry should be aware of?

VRS is the first interoperable system in the DSCSA. Error management and handling the complexities involved with the enormous volume of returned products contributed to its delay until 2023. (Read our articles about the FDA’s decision to delay enforcement of the DSCSA saleable returns requirement.) Downstream partners only add to the volume and complexity the VRS must handle in sub-second time. So, it will be important for the industry to determine exactly how the VRS will be used and what type of volume controls and error management it will have. You must also consider what type of outcomes your partners will need, as well as what you need for your own business model.

What are some of the “sticking points” with the VRS today?

The Healthcare Distribution Alliance (HDA) collected feedback from the industry about optimizations/improvements it would like to see in the VRS network and presented its findings to solution providers on June 11, 2021. We’re now in the process of evaluating the feedback to determine next steps.

The “sticking points” fall into six categories, as shown in the graphic below. The most predominant concern is how to deal with data synchronization issues. The process for resolving all these issues needs to be streamlined among service providers.

Industry Feedback on DSCSA VRS

What’s the current implementation rate and use of VRS?

That depends on which part of the supply chain you are referring to. There is no accurate estimate of this across the industry, but based on our observations, this is what we’re seeing: Manufacturers and distributors have the highest “implementation rate.” Approximately 70-80 percent of our manufacturers can support VRS and 80-90 precent of wholesalers/distributors are VRS ready. The numbers further down the supply chain are lower, but are increasing quickly as dispensers become more aware of the benefits of VRS.

My wholesale distributor takes care of VRS for me. What is my responsibility? Am I covered if I were to be audited?

This is a little tricky, because there’s a lot of information circulating about what wholesale distributors will and will not do in the VRS ecosystem.

Wholesale distributors are doing a lot of heavy lifting with VRS, but they’re not completely responsible for your DSCSA transactions. They’re responsible for your information that’s being plugged into the VRS, but they are not responsible if there are any problems with a returned product.

The simple truth is that every stakeholder is responsible for their own DSCSA compliance. Your wholesale distributor should be there to help coordinate to the extent of the arrangement and partnership you have, but they are not responsible for your compliance. It’s not their job to “take care of VRS” for you. As we get into 2023, you’re going to need hardware, software, and system updates ready to go, and you can’t “pass the buck” for VRS to your wholesale distributor — or any other trading partner.

More DSCSA 2023 resources from rfxcel

Traceability in the Food Supply Chain

Traceability has always been an important part of the food supply chain. It helps ensure food safety, speeds recalls and investigations, and makes the food supply chain faster and more efficient. In recent years, however, there has been a stronger push for traceability from regulators and consumers alike.

Regulators, notably the U.S. Food and Drug Administration, have developed new traceability requirements for food products, including rules governing specific types of food (i.e., those that are more prone to contamination), guidance for stakeholders to collect more data at every node of the food supply chain, and modern, digital systems to optimize safety and efficiency and aid recall management.

Similarly, consumers are demanding more information about the foods they eat. They want a demonstrable provenance of what they’re taking home to their families, “on-demand data” that demonstrates that foods are exactly what companies say they are. And if they don’t get this, they’re only too happy to take their business somewhere else — and let other people know that Brand XYZ isn’t living up their expectations of quality and transparency.

Every stakeholder in the food supply chain, from manufacturers and processors to distributors and retailers, has to think about traceability. If they don’t, they’re risking problems with regulators, alienating consumers, damaging their brand reputations, and, ultimately, putting their business in jeopardy.

This rfxcel white paper covers the fundamentals of traceability in the food supply chain. It describes how critical tracking events (CTEs) and key data elements (KDEs) build “digital assets,” that can be traced (and tracked) from farm to fork. It takes an in-depth look at the FDA’s initiatives to modernize the U.S. food supply chain using digital technology, including the Food Safety Modernization Act (FSMA), the “New Era of Smarter Food Safety,” the “Food Traceability List,” and the pending “Requirements for Additional Traceability Records for Certain Foods,” also known as the Proposed Rule. It also describes the many benefits of food traceability, which include better consumer engagement and brand protection.

 

Dairy Traceability in 2021: The FDA, the Industry, and the Future

It’s June, and it’s definitely ice cream season! It was 96°F (35°C) at our headquarters in Reno, Nevada, yesterday. Naturally, when we think of ice cream, we think about dairy traceability. Dairy traceability ensures consumer safety and keeps vital supply chains moving.

Most of our readers can probably assume that their food was manufactured, processed, transported, and stored safely and in accordance with quality standards and safety regulations. But the World Health Organization estimates that 600 million people are sickened from contaminated food products every year — and as many as 420,000 die. Dairy products are among the biggest culprits, as they can carry pathogens that cause foodborne illnesses.

The implications are significant. And they illustrate why dairy traceability is so important. Let’s take a look at where we are with dairy traceability in 2021.

Dairy traceability: the industry perspective

Dairy traceability has been on the industry’s radar for quite some time. For example, the Innovation Center for U.S. Dairy has been an advocate since at least 2009, when its Globalization Report noted that traceability was, in so many words, the future of the dairy supply chain.

In 2013, the Center published Guidance for Dairy Product Enhanced Traceability. Now in its third iteration (July 2020), it addresses much of what the FDA wants, including establishing and maintaining records with key data elements (KDEs) associated with critical tracking events (CTEs). There’s also a 21-point Dairy Traceability Checklist that manufacturers can use to evaluate if they follow enhanced dairy traceability best practices.

Last, the Center created the U.S. Dairy Traceability Commitment, “designed by processors, for processors, to increase global competitiveness, help satisfy future requirements of the Food Safety Modernization Act (FSMA) and, in the rare event of a safety issue, quickly isolate products to protect public health and prevent brand damage.”

Dairy traceability: the FDA perspective

Traceability — including dairy traceability — and modernization have also been on the FDA’s radar. We’ve written about this before, so we won’t drill down into the details today. In a nutshell:

The new requirements, also known as the Food Traceability Proposed Rule, apply to many popular cheeses, including brie, camembert, feta, mozzarella, Monterey Jack, cottage cheese, ricotta, and queso fresco.

Dairy traceability in 2021

Just about a year after the FDA announced its New Era of Smarter Food Safety Blueprint and the Innovation Center for U.S. Dairy updated its Guidance for Dairy Product Enhanced Traceability, it’s clear the dairy industry and the FDA are trying to get on the same page.

Generally, the industry has been receptive to the FDA’s efforts. The International Dairy Foods Association, for example, supports the New Era of Smarter Food Safety Blueprint. Still, many in the industry say the Food Traceability Proposed Rule isn’t necessary because supply chain stakeholders have been modernizing and building traceability systems without a government mandate.

With that in mind, the International Dairy Foods Association submitted comments to the FDA asking it to revise the recordkeeping requirements, arguing that doing so would support more widespread adoption of dairy traceability across the industry, to the ultimate benefit of the public. The Association is also working with the FDA to ensure dairy manufacturers have the proper direction and tools that support more efficient food safety practices and dairy traceability protocols.

Final thoughts

This quick sketch of dairy traceability makes two things clear. First, the FDA is all-in on modernization and traceability. Second, the industry understands the need for dairy traceability and has shown its willingness to commit to maintaining a modern, traceable supply chain.

In this environment, rfxcel’s traceability solutions will help dairy companies in any market modernize their food safety protocols, facilitate end-to-end traceability in a digital supply chain, comply with evolving regulations, and maintain trust with customers. Contact us for more information about how we can help, and check back soon for more about traceability in the food supply chain.

 

rfxcel, Part of Antares Vision Group, and MVC Launch the Traceability Hub for the Kingdom of Bahrain to Track End-to-End Pharma Supply Chain

Travagliato (Brescia), June 3, 2021 (MarketScreener). Antares Vision Group, the international leader in the pharmaceutical sector for track and trace hardware and software solutions (anti-counterfeiting and supply chain transparency), with an established presence in inspection systems (quality control), and active in smart data management (production efficiency and end-to-end supply chain digitalization, from raw materials to the final consumer), announced today that its subsidiary rfxcel has successfully implemented an end-to-end Traceability Hub to monitor and secure the Kingdom of Bahrain’s global pharmaceutical supply chain process. The initial value of this contract is approximately 4-6 percent of Antares Vision FY 2020 pro-forma revenues.

Bahrain’s National Health Regulatory Authority (NHRA) and Supreme Council of Health selected Medical Value Chain (MVC) and its partner rfxcel to provide the first GS1-compliant system to track its entire pharmaceutical supply chain on a blockchain platform. The end-to-end Traceability Hub delivers complete visibility into every node of the Kingdom’s supply chain, from the manufacturer of origin, importers, wholesalers, and distributors to pharmacies, clinics, and hospitals — all the way to individual patients.

The objective of the NHRA Bahrain Traceability Hub is to achieve following:

  • End-to-end traceability for all medicine imports to Bahrain
  • Bahrain pharma supply chain to meet the global track and trace requirements and GS1 standards
  • Complete visibility and repository of medicine inventory and supply-chain info from manufacturers to agents/importers to wholesalers/distributors to pharmacies/hospitals and to patients/consumers
  • Increase patient safety
  • Detect and stop counterfeit medicines
  • Analytics of medicine imports and consumption in Bahrain
  • Manage product recalls and shortages efficiently and quickly

Glenn Abood, rfxcel CEO, said, “The end-to-end Traceability Hub offers an array of other benefits for all pharmaceutical supply chain stakeholders. The Hub is the first of its kind in the Gulf Cooperation Council. It creates a single source of truth for all medications, which means improved patient safety, better flow of information, and more accurate inventory management. It is also a powerful tool to prevent counterfeit and substandard drugs from reaching the market.”

Emidio Zorzella, Antares Vision Group CEO, said, “I am honored that the Kingdom of Bahrain chose Antares Vision Group in partnership with MVC to secure and optimize its pharma supply chain. In the near future, we expect to announce national traceability hubs in other countries to track pharmaceutical, agricultural, and consumer products.”

MVC President Leo Giacometto said, “When we set up our company to provide a blockchain-enabled track and trace platform to provide customs clearances and supply chain financing, we needed the absolute best track and trace solution and most experienced team in the market; that is rfxcel, now part of Antares Vision Group!”

ABOUT RFXCEL

Part of Antares Vision Group, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, lower costs, and protect their products and brand reputations. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s signature Traceability System (rTS) to power end-to-end supply chain solutions in key areas such as track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. Founded in 2003, the company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.

ABOUT ANTARES VISION GROUP

Listed since April 2019 on the Italian Stock Exchange in the AIM Market, and from 14 May 2021 on Mercato Telematico Azionario (MTA) STAR segment, the Antares Vision Group guarantees protection of products, people and brands through inspection systems for quality control, Track & Trace solutions for anti-counterfeiting and supply chain transparency, smart data management tools for maximized efficiency and digitalization of the supply chain, from raw materials to the final consumer. The Antares Vision Group is active in the pharmaceutical market and in Life Science in general (biomedical devices and hospitals), in beverage, food, cosmetic and in consumer-packaged goods. The Group reaches over 60 countries in the World with complete and flexible solutions, hardware, and software, with related services and counts 7 production facilities in Italy (Brescia, Parma, Piacenza, Latina, Padua and Vicenza), 22 foreign subsidiaries (Germany [2], France [2], USA [5], Brazil [2], United Kingdom [2], India, Russia [3], Hong Kong, China, Ireland, Croatia and Serbia), 3 Innovation and Research Centers (Italy) and a worldwide network of more than 40 partners. Thanks to the twenty years of experience in vision technologies of the two founding partners, the Antares Vision Group is the supplier of 10 out of 20 leading pharmaceutical companies in the world, with more than 25.000 inspection systems, that ensure everyday product safety and quality, 6.500 quality controls and more than 3.500 serialization modules on lines installed all over the. With the aim of continuing and supporting the growth and development strategy, during 2019 participation agreements were finalized with T2 Software, a Brazilian company specialized in smart data management solutions, and Orobix, an Italian company leader in artificial intelligence services, as well as the acquisition of 100% of FT System, leader in control and inspection in the beverage sector. In 2020, Antares Vision acquired 82.83% of Tradeticity, a Croatian company specialized in software management of traceability and serialization processes, 100% of Convel, an Italian company specialized in automated inspection machines for the pharmaceutical industry, the assets of Adents High Tech International, a French company specialized in software for serialization and traceability, 100% of Applied Vision, a global leader in inspection systems for glass and metal containers in food beverage. In March 2021, Antares Vision acquired 100% of rfxcel Corporation, specialized in software solutions for digitalization and supply chain transparency based in the U.S., and 100% of Pen-Tec and Tecnel, through FT System, increasing specialization in Food & Beverage inspection sector. In 2019 Emidio Zorzella and Massimo Bonardi won the Ernst & Young “Entrepreneur of the Year” award for innovation.

For further information:

ANTARES VISION S.P.A.

Via Del Ferro, N. 16

25039 – Travagliato (BS)

Alessandro Baj Badino, Investor Relator

Tel.: +39 030 72 83 500

E-mail: Investors@antaresvision.com

RFXCEL

Herb Wong, Vice President of Marketing and Strategic Initiatives

Tel.: +1 925-791-3235

E-mail: hwong@rfxcel.com

IR ADVISOR

IR Top Consulting

Via Bigli, N. 19

20121 – Milano

Tel.: +39 02 45473884

Maria Antonietta Pireddu: m.pireddu@irtop.com

Antonio Buozzi: a.buozzi@irtop.com

 

 

rfxcel DSCSA 2023 Webinar Series: Sneak Peek #1

Full serialization of the U.S. pharmaceutical supply chain is coming in November 2023. That may seem like a long way off, but time flies and it will be here before you know it. To help make sure you’re working toward that deadline and doing everything you can to be prepared, we’re hosting the rfxcel DSCSA 2023 webinar series on June 15, 16, and 17.

Our Executive Global Advisor Brian Files, an expert on U.S. and international pharmaceutical compliance, will present three key aspects of the DSCSA and answer your questions. Sign up today!

  1. Tuesday, June 15: The Verification Router Service: Aligning to the Standard
  2. Wednesday, June 16: ASN to EPCIS: Industry Change, Your Challenge
  3. Thursday, June 17: Authorized Trading Partners: The OCI Solution

Here’s a sneak peek about the DSCSA Verification Router Service (VRS). Check back for more sneak peeks leading up to Brian’s other presentations in our rfxcel DSCSA 2023 webinar series!

What is the DSCSA?

The DSCSA went into effect on November 27, 2013. It calls for product tracing, product identifiers (PIs), authorized trading partners, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies). As we said above, full serialization will begin in November 2023 (the 27th, to be exact).

What is the DSCSA saleable returns verification requirement?

Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. This is done by verifying the drug’s PI, which comprises a Standardized Numerical Identifier (National Drug Code and a unique alphanumeric serial number), a lot ID, and an expiration date.

How does the DSCSA saleable returns requirement work?

A wholesaler must initiate a verification request (to a manufacturer) to verify the returned products. The manufacturer must provide a verification response within 24 hours. Wholesalers are called requestors and manufacturers are called responders.

The VRS and the DSCSA saleable returns verification requirement

The VRS enables the rapid, secure exchange of data between requestors and responders to meet the DSCSA saleable returns verification requirement. It’s an automated service that verifies if a PI is valid. A solution provider enables the verification requests to be routed between wholesalers and manufacturers.

Final thoughts

Be sure to join Brian on June 15 for “The Verification Router Service: Aligning to the Standard,” the first in our rfxcel DSCSA 2023 webinar series. Register today and submit your questions for Brian. You can also contact us to talk with one of our supply chain experts and see how our award-winning rfxcel Traceability System can ensure you comply with the saleable returns verification requirement and other key DSCSA requirements.

See you on June 15!

DSCSA 2023 Webinar_June 15-17

Food Traceability Data: Not Just for Compliance Anymore

As the Food and Drug Administration (FDA) continues to evolve its traceability and modernization initiatives across the U.S. food supply chain, the need for more accurate food traceability data is more important than ever.

Foundationally, the FDA’s initiatives require companies to have digital traceability systems in place that facilitate greater food safety. But food traceability data means more than ensuring you’re complying with regulations: It offers significant business value. Let’s take a look.

FDA’s food traceability initiatives: a refresher

In 2011, Congress enacted the Food Safety Modernization Act (FSMA) to regulate the way foods are grown, harvested, and processed in the United States. The law transforms the nation’s food safety system from an after-the-fact response to foodborne illness to a proactive posture aimed at prevention.

To address the rapid and effective tracking and tracing outlined in FSMA, the FDA in April 2019 launched the New Era of Smarter Food Safety, a tech-enabled approach to food traceability to ensure food safety, and the New Era of Smarter Safety Blueprint (July 2020), which outlined the Agency’s vision for how to get there and included the Food Traceability Proposed Rule, which defines specific traceability recordkeeping requirements for foods on its Food Traceability List.

Food traceability data delivers benefits beyond mere compliance

Although food traceability data serves as the cornerstone of effective recall management and outbreak prevention as required by the FDA, it means much more than compliance. Here are three ways food traceability data can drive business value to support sustainable growth.

Create operational efficiencies

Food traceability data yields complete, real-time visibility into operations across every node in the supply chain. This empowers food companies to take immediate action, solve problems, coordinate with partners and regulators, and keep things moving.

For example, by tracking a product’s ingredients from harvest through production through the last mile to delivery, you can quickly trace raw materials backward and forward, pinpoint supply chain weaknesses or trouble spots, and strengthen your recall program and minimize the impact of recalls. And with a traceability system that allows you to monitor products anywhere in transit, you can collect data on environmental conditions, track the location of all your deliveries, and set precise parameters for alerts.

This food traceability data allows you to proactively protect your shipments, safeguard their environmental integrity, track their position on land, sea, and air, and intervene immediately should something seem awry, such as a spike in temperature or a route diversion. Add critical tracking events (CTEs) and other information (e.g., quality inspections) to the process and you’ve got an indelible product provenance from farm to table.

Build consumer engagement and trust

These days, consumers are more attuned than ever to family health and finances. They want to know more about what they’re eating, such as ingredients, how food is raised or grown, and the safety and environmental practices used to produce it. They want to feel good about what they eat and where they are spending their money. By supplying information that meets this demand, you build trust and loyalty and build a community of customers who will advocate for your products.

The simple truth is that food traceability data creates tremendous opportunities to communicate with consumers and nurture more committed relationships. You can back your claims and prove your product is what you say it is.

Protect your brand

This dovetails with consumer engagement and trust. With modernized, secure, and compliant food traceability protocols, you can better collaborate with partners and authorities if there’s a recall. In this scenario, you’re not only protecting consumers from a health hazard — you’re safeguarding your brand from bad publicity. And with a transparent approach to engaging with customers about the foods they consume, you create a strong brand image that conveys trust, credibility, and reliability. You can even use your food traceability data as a core differentiator in your value proposition messaging.

Final thoughts

Food traceability data has always been important, but the FDA has clearly put it center stage with FSMA, the New Era of Smarter Food Safety, the Food Traceability Proposed Rule, and the Food Traceability List.

Do not expect this to change.

rfxcel believes industry leaders will see traceability as an investment in their businesses and brands, not a compliance mandate from the government. If fact, savvy companies will know the FDA’s initiatives are an opportunity to be involved in shaping the future of the U.S. food supply chain. Keep an eye out this summer for more from rfxcel about how you can tap into the FDA’s initiatives to help lead the transformation of the U.S. food supply chain. As we said above, this is a moment of opportunity for the food industry. Don’t miss the boat.

In the meantime, take a look at our solutions for food and beverage:

Contact us today for more information and to schedule a short demo of our food traceability solutions. Get started now and take advantage of all the opportunities food traceability data can create for you.

Food Traceability Regulations in the United States: A Timeline

The U.S. Food and Drug Administration (FDA) is orchestrating the construction of a more robust, technology-driven approach to food traceability and safety. And it’s happening as the food industry is undergoing major change, including scores of new foods being introduced to the market, rising consumer demand for more information about the food they buy, the development of more sophisticated production and delivery methods, and a growing push for digitization of the supply chain.

As regulations in the United States continue to evolve, manufacturers, wholesalers, distributors, and retailers need to keep a finger on the pulse of the latest developments. Today, we’ll help with a quick rundown of what’s happened with food traceability over the last year.

Food traceability regulations in the United States: 2020-present

On September 23, 2020, the FDA published “Requirements for Additional Traceability Records for Certain Foods” on its Food Traceability List. Referred to as the “Food Traceability Proposed Rule,” it’s part of the FDA’s New Era of Smarter Food Safety Blueprint and aims to standardize the data elements and information required to rapidly and accurately identify foods that may be causing illness. It defines additional recordkeeping requirements for businesses that manufacture, process, pack, or hold foods on the FDA’s Food Traceability List, which must establish and maintain records containing key data elements (KDEs) associated with specific critical tracking events (CTEs).

In January 2021, the FDA made clarifying modifications to the Food Traceability List and published a detailed FAQ that answered commonly asked questions that emerged following the announcement of the Proposed Rule. In February 2021, the comments period for the modifications closed. The FDA has until November 2022 to finalize it.

More about the New Era of Smarter Food Safety Blueprint

These initiatives are part of the FDA’s New Era of Smarter Food Safety. Announced in April 2019, it envisions a modern approach to ensuring food safety through digital, tech-enabled traceability.

The New Era of Smarter Food Safety Blueprint, announced in July 2020, outlines the FDA’s methodology for achieving its traceability and safety goals. It’s based on the following four pillars, which leverage a range of technologies, analytics, business models, modernization, and values as its building blocks:

1. Tech-enabled food traceability

A supply chain that includes paper-based recordkeeping and yields insufficient data makes it difficult to track and trace foods rapidly. Fast, accurate food traceability is essential to safeguarding consumers’ health — and your brand reputation and bottom line.

For example, modernized food traceability that leverages the latest technologies and integrates expanding data streams empowers supply chain stakeholders to identify an outbreak and trace a contaminated food product’s origin within minutes — or even seconds — and be proactive about getting the product off of shelves.

2. Smarter tools and approaches for prevention and outbreak response

In addition to better food traceability, the FDA wants to ensure the root cause of an outbreak or contamination can be easily identified to support a prevention-based approach. To do this, stakeholders need to incorporate new knowledge while continuously assessing how they can make processes and communications more effective and efficient. As more data becomes available, the use of predictive analytics tools becomes increasingly important to predict when a significant food event may occur. With this information, manufacturers can prevent a contaminated food products from entering the supply chain or target efforts to remove a potentially contaminated product from the market.

3. New business models and retail modernization

As the industry continues to find new ways to produce and distribute food, the FDA is seeking to explore new approaches in ensuring food traceability and safety. This includes:

  • Educating supply chain actors on the importance of food safety issues
  • Adapting FDA oversight to ensure the safety of novel ingredients, new foods, and new food production methods
  • Advancing the safety of foods sold in traditional retail establishments
4. Food safety culture

The FDA wants to encourage an environment of support for a stronger food safety culture on farms, in food facilities, and in homes. If the food industry does not commit to embracing food traceability and safety, real improvements will be difficult to achieve.

Final thoughts

We can be certain of two things when it comes to food traceability regulations in the United States: they’re going to keep evolving and they’re not going away. The good news is advancements in technology are making it profoundly easier — and even more affordable — to ensure food traceability across the entire supply chain. Yes, the FDA’s proposed requirements technically apply only to items on the Food Traceability List, but the Agency is encouraging voluntary adoption of these practices industry-wide. Savvy food companies will see this as an opportunity to get involved early and be part of the process, helping to set the industry’s regulatory course while going a long way to secure their own business.

rfxcel can help you comply with U.S. food traceability regulations today, tomorrow — always. From raw ingredients to finished goods, our rfxcel Traceability System (rTS) offers end-to-end food supply chain traceability and visibility. Our rfxcel Integrated Monitoring (rIM) is a real-time traceability and supply chain visibility solution that helps you remotely monitor products in transit And our MobileTraceability app brings the power of rTS to every node of your operations, including places that have traditionally been “blind spots.” Contact us today to arrange a demo.