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Drug Supply Chain Security Act Pharmacy Responsibilities

Drug Supply Chain Security Act pharmacy responsibilities are complex. They can be confusing. But the clock is ticking to be ready for the November 27, 2023, deadline. Let’s do a quick recap for pharmacies.

What is the U.S. Drug Supply Chain Security Act?

The U.S. Drug Supply Chain Security Act, enacted on November 27, 2013, establishes a system to track and trace prescription drugs in a fully serialized supply chain. It calls for end-to-end traceability and electronic interoperability to prevent counterfeit, stolen, contaminated, or otherwise harmful drugs from entering the U.S. supply chain.

So far, the DSCSA has mostly focused on lot-level traceability — exchanging information about every package of medication so stakeholders can see exactly where it has been. Enactment culminates in November 2023, with complete unit-level serialization of the U.S. drug supply chain. This means stakeholders will have to electronically track products at the individual package level.

Drug Supply Chain Security Act pharmacy responsibilities: definitions

Pharmacies are referred to as “dispensers” in the DSCSA. The legislation defines a dispenser as “a retail pharmacy, hospital pharmacy, a group of chain pharmacies under common ownership and control that do not act as a wholesale distributor, or any other person authorized by law to dispense or administer prescription drugs, and the affiliated warehouses or distribution centers of such entities under common ownership and control that do not act as a wholesale distributor.”

If you dispense only products to be used in animals, you are not a dispenser under the DSCSA.

How to comply with the DSCSA

As we said above, the Drug Supply Chain Security Act pharmacy responsibilities are complex. Let’s break them down into easy-to-understand pieces.

You must exchange “T3” information about every drug you buy and who handled it each time it changes ownership in the United States.

The DSCSA calls this “product tracing information.” It has three components, collectively called “T3” information:

  1. Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form)
  2. Transaction History (TH), an electronic statement with the TI for every transaction going back to the manufacturer
  3. Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership.
You must receive, store, and provide product tracing documentation

You can accept prescription drugs only if they have proper T3 information, and you must store the T3 information for six years. You must also generate and provide all T3 information when you sell a prescription drug to a trading partner.

You can only do business with authorized trading partners (ATPs)

And speaking of trading partners, if you can’t confirm your they’re licensed or registered, you can’t do business with them. If they’re not authorized, their access to the U.S. pharma supply chain will be severely restricted or denied altogether. Read our in-depth ATP blog series for all the details.

You must investigate and properly handle suspect and illegitimate drugs

Suspect and illegitimate drugs include drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution — the problem the DSCSA was designed to eliminate. Pharmacies must quarantine and investigate these drugs to determine if they are fake. If you make this determination, the next step is to work with the manufacturer and take specific action to ensure the bad drug does not reach patients/consumers. You must also notify the FDA and your trading partners about the drug.

You must authenticate and verify drugs

This is what’s coming in 2023. You’ll have to be able to authenticate and verify all the medicines you buy before you can sell them. The fundamental requirement is that TI (transaction information) must include a product identifier (PI), which includes serial numbers and expiration dates. The Electronic Product Code Information Services (EPCIS) is likely to be the standard the industry will use to enable this exchange.

Final Thoughts

We’re writing this on November 24, 2021. Yes, it’s the day before Thanksgiving. (Happy Thanksgiving!) It’s also almost exactly two years from the DSCSA implementation deadline. That may seem like a long time, but …

It is definitely not a long time. There’s a lot to do to ensure you’ll comply with your Drug Supply Chain Security Act pharmacy responsibilities. If you aren’t sure you’ll be ready, contact us to schedule a short demo of our DSCSA solutions. Our team of supply chain experts will design a solution to ensure you meet all DSCSA requirements and remain compliant forever.

And if you’re looking for something to read over the Thanksgiving holiday, download our “Dispensers and DSCSA 2023” white paper. It drills down into what we talked about today and is a great reference tool to have on hand as you prepare for the full serialization of the U.S. pharma supply chain.

Happy Thanksgiving!

Brand Protection Strategies and Your Supply Chain

Welcome to Part II of our brand protection series. In Part I, we talked about the top supply chain threats that brand protection strategies must address: counterfeits, diversion, theft, and insufficient traceability.

Today, we’re talking about the supply chain solutions that combat these threats — solutions that should be integral to your brand protection strategies.

A holistic supply chain approach to brand protection strategies

Your supply chain is the embodiment of your business. If it’s not healthy, your brand can’t be healthy. You need to be able to continuously scan it, diagnose it, and take immediate action should a threat arise.

Fine-tuned digital supply chain solutions are the answer. Working together from end to end, they create a “central nervous system” that monitors and senses every touch point in real time while collecting and sharing data to inform your next move.

Serialization, real-time monitoring, and end-to-end traceability are the key solutions that help mitigate supply chain threats and provide the intelligence for effective brand protection strategies. Let’s take a look.

Serialization

Serialization is the building block of a secure supply chain and effective brand protection strategies. By assigning a unique serial number to each product, you create what rfxcel calls a “digital asset” with a unique digital identity. Every product can be linked to virtually any information you want, such as its origin, when it was harvested or manufactured, its lot number, and its expiration date.

Serialization also enables you to track every individual unit through your entire supply chain, from production to retail distribution to the final consumer and beyond. It creates a barrier to fight counterfeits and fakes and contributes to end-to-end traceability that eliminates blind spots and locks down your supply chain.

Serialization also fuels brand protection strategies because you can leverage each digital asset for consumer engagement to build confidence and trust. As we said in Part I of our consumer engagement series, your customers are absolutely a part of brand protection, and serialization empowers them in three important ways.

First, it’s the basis of an indelible, demonstrable, shareable product provenance that proves that your product is what you say it is and gives consumers the information they demand.

Second, as we discussed in Part II of our consumer engagement series, your serialized product is a device for one-on-one communication with your customers. For example, with a quick smartphone scan of a 2D Data Matrix code, a person can access rich data about your product and exclusive content through which they’ll establish and build a relationship with your brand.

Third, serialization lets you “crowdsource” brand protection through your consumer engagement activities. For example, if a person scans a product and the scan doesn’t work or they’re taken to a suspect website or other suspicious content, you can incentivize them to contact you and report that something is wrong. This is actionable, granular data that will protect your brand.

Real-time monitoring

A blind spot in your supply chain creates opportunities for trouble. Common blind spots include deviations from prescribed routes and harmful environmental conditions. The solution is real-time monitoring.

rfxcel’s Integrated Monitoring solution paints a vibrant, detailed picture of where your products are and what is happening to them. It provides better data, continuity, visibility, and security to protect your products and consumers. With detailed, unit-level data coming in around the clock, you’ll understand and immediately act upon specific risks.

It works like this: Pallets, cases, or unit-level items are equipped with Internet of Things (IoT)-enabled sensors that send data over communication networks at regular intervals. The sensors provide real-time information about how long an item has been in transit, if the transport vehicle is sticking to its approved route, if the shipment stopped and for how long, and environmental conditions such as temperature, light, humidity, and shock. If something is not as it’s supposed to be, the sensors transmit an alert so you can halt shipments that may have been adulterated and redirect shipments to keep products safe. You’ll protect your customers and safeguard your brand.

Check out our short videos about our Integrated Monitoring solution for the pharmaceutical and food and beverage industries.

End-to-end traceability

End-to-end traceability in a digital supply chain means you can design end-to-end brand protection strategies.

With a suite of solutions acting in concert — like our Traceability System — you’ll create a full, traceable provenance for every product. You can add critical tracking events and key data elements at any point in your supply chain. For example, add a photo of a product as it leaves the factory or integrate a quality inspection to enrich the data associated with the product. Consumers can access this information and confirm that your product is what you say it is. This burnishes your reputation and builds trust with the people who buy your products or are thinking about buying your products.

rfxcel Traceability System

And there are numerous other benefits of end-to-end traceability. If you can see every part of your supply chain from one end to the other, you’ll be able to manage operations more efficiently, including dealing with recalls and other crisis situations. You’ll make it harder for counterfeits and fakes to reach consumers. You’ll consolidate data to improve processes, outcomes, and product quality. And you’ll be empowered to make better decisions based on that data.

Mobile traceability: an on-the-go solution for brand protection strategies

A discussion of brand protection strategies isn’t complete without mentioning mobile traceability. Why? Because if you don’t have access to your supply chain data 24/7, no matter where you are, you’re not shedding light on blind spots and not building a solid perimeter around your brand.

rfxcel’s MobileTraceability solution brings our industry-leading track and trace capabilities to virtually any location, including places that traditionally may not have had absolute visibility in your supply chain, such as remote fields, distribution centers, and warehouses. With unparalleled convenience and speed, it gives you everything you need to keep you supply chain running at optimal efficiency. To learn more, read about what our Mobile Traceability solution can do for the pharmaceutical and food and beverage supply chains.

Final thoughts

A supply chain problem is a brand protection problem. By giving all your products a unique digital identity through serialization, then following and controlling them in real time with integrated monitoring and traceability solutions, you can demonstrate to the world that your brand is strong and reliable. You can build a reputation for integrity and transparency with partners and consumers. You can use data to innovate your brand protection strategies, consumer engagement activities, and every part of your operations.

With rfxcel, you can fortify your brand with data from a digital supply chain. You can combat the threats we’ve discussed no matter where you are and no matter where you supply chain goes. Contact us today to see how our solutions can work for better, stronger brand protection strategies.

Brand Protection Strategy and the Top Supply Chain Threats

We just did two articles about why your supply chain is vital to an effective consumer engagement strategy. Now we want to jump into brand protection strategy and your supply chain.

First, let’s define our terms. Although consumer engagement is a usually a dedicated effort to boost brand recognition and loyalty, it must always be considered part of your brand protection strategy. As we’ll see, getting your customers involved in fighting counterfeits and identifying disreputable sellers and other bad actors is critical. Let’s continue breaking this down.

Why do you need a brand protection strategy?

Do you want to protect your business? Your employees, your bottom line, your reputation, your supply chain, your intellectual property?

Of course you do. Your brand protection strategy is your firewall. It’s how you shield your business from things that can harm it. And many — if not most — of the factors that can harm your brand are directly related to your supply chain. These include counterfeits (also called fakes), diversion, theft, and insufficient traceability.

Top supply chain threats

Let’s take a closer look at the top supply threats your brand protection strategy should address.

Counterfeits and fakes

The joke is that the best way to fight counterfeits is to make products nobody wants to buy.

We know that’s not how it works, though, which is why counterfeits and fakes are the No. 1 brand protection concern. In fact, counterfeits and pirated products accounted for up to 3.3 percent of world trade in 2016.

That statistic comes from a 2019 report by the Organisation for Economic Co-operation and Development (OECD) entitled “Trends in Trade in Counterfeit and Pirated Goods.” The OECD also found that trade in counterfeit and pirated goods was rising steadily despite stagnation in overall trade volumes. Based on 2016 customs seizure data, the value of imported fake goods worldwide was $509 billion, up from $461 billion in 2013.

But there’s a lot more to be concerned about. Counterfeits are of inferior quality and often contain harmful, even deadly, materials/ingredients. The people who make them, including children, often work for long hours in sweatshop conditions. Some may have been trafficked or coerced. Furthermore, it has been established that counterfeits are inextricably linked to organized crime.

The pandemic provided many examples counterfeits making their way into the global supply chain — fake vaccines, fake COVID-19 testing kits, fake masks, fake nitrile gloves. But counterfeiting affects every industry, from food and footwear to cosmetics and computers.

Diversion and theft

When your goods are in transit along your supply chain, you want them to reach their final destination as quickly and safely as possible. This is why diversion is another key consideration for a brand protection strategy.

Diversion is actually a two-pronged problem. Let’s use pharmaceuticals to illustrate. Many drugs must be kept within a certain temperature range or maintained under certain lighting or humidity conditions. Even the slightest delay could spell disaster — ruined products, which means patients might not get medicines on time.

Diversion can also indicate theft. If a truck goes off its prescribed route, bad actors might be hijacking it and your product could end up on unauthorized e-commerce sites (rogue websites) and other grey markets or black markets. If the diversion has compromised the integrity of your product — a drug, for example — people’s lives may be jeopardized.

Insufficient traceability

As we’ve discussed before, supply chain traceability brings tangible value to just about every part of your business, including your brand protection strategy. If you’re not taking traceability seriously, you’re not just opening the door to assaults on your brand; you’re risking problems with regulators, alienating (and losing) customers, and weakening your supply chain.

A recall is among the most damaging events that can happen to a brand, so let’s use it as case study. If you can trace a recalled item, you can better collaborate with trading partners and authorities and help to get the product out of the supply chain and out of stores. With traceability, you’re protecting consumers from a health hazard and safeguarding your brand from bad publicity. And with a transparent approach to engaging with customers about your products, you create a strong brand image that conveys trust, credibility, and reliability.

Traceability also helps fight counterfeits, diversion, and theft. The ability to trace and authenticate every product in your supply chain in real time, 24/7, is foundational to an effective brand protection strategy. We’ll get into those details in Part II of our brand protection series.

Final thoughts

At the end of August, the Office of the United States Trade Representative published a request for comments “that identify online and physical markets to be considered for inclusion in the 2021 Review of Notorious Markets for Counterfeiting and Piracy (Notorious Markets List).”

Counterfeits have also been making headlines in recent weeks:

In this environment, a comprehensive brand protection strategy driven by granular supply chain data is your best defense against bad actors. rfxcel understands this. We can help you leverage your supply chain to combat counterfeits and the other concerns we addressed today. Our brand protection solutions will fortify your brand with data from a digital supply chain. Contact us today to learn more — and check back soon for Part II of our brand protection series.

Top Reasons Your Supply Chain Is the Key to an Effective Consumer Engagement Strategy

Welcome to Part II of our series about effective consumer engagement. In Part I, we talked about the benefits of consumer engagement. Today, we’re focusing on your supply chain — and how you can use it for a next-level consumer engagement strategy. Let’s jump right in.

It’s all about data from your supply chain

Your supply chain is a gold mine of information that you can leverage for a robust consumer engagement strategy. The basic building block is serialization, which turns each one of your products into what we call “digital assets.” Each digital asset has a unique digital identity that can be monitored from production all the way to the person who buys it.

With rich, traceable data about every item in your supply chain at your fingertips, you can establish and maintain connections with consumers before, during, and after the sale. (You can also do much, much more, but that’s beyond the scope of what we’re talking about today.)

Four ways supply chain data can supercharge your consumer engagement strategy

1. You’ll share the product information that consumers demand. Consumers demand information. Every product — every digital asset — in your supply chain can be “loaded” with data that consumers can access at the store, at home, at a restaurant, at a sporting event. Anywhere. For example, a quick scan of a 2D Data Matrix code or QR code with a smart phone will reveal every detail you want to share about your product: where and when it was grown or made, its ingredients, the route it took to get to the consumer. This demonstrable provenance using supply chain data builds consumer trust and confidence; it is foundational to consumer engagement.

2. You’ll create compelling customer experiences. Consumers also want experiences. With data from your supply chain and other brand resources (e.g., an app) you can curate experiences such as contests, loyalty programs, games, and unique online content. You can encourage storytelling about your brand. If you’re a winemaker, connect people to a virtual tour of your vineyard. If you sell organic foods, share video recipes online or invite people to see your sustainable operations. If you make cosmetics, link to virtual try-ons. Importantly, you can hyper-personalize and hyper-target every engagement, and even “broadcast” specific information to specific locations or events.

3. You’ll communicate directly with consumers. Your serialized product is a device for one-on-one communication with the person who bought it. When a customer accesses the information from your digital asset, you can connect them to your website, social media, an app, a survey, or other forums where they can start a conversation with your brand. They can ask questions and provide feedback — and you can give answers and reactions. Relationship-building is another cornerstone of an effective consumer engagement strategy, and the products people are literally holding in their hands are the first step of the conversation.

4. You’ll gain valuable insight into your customers. An effective consumer engagement strategy creates a world for your customers. And as they navigate and participate in that world, they share information. Where are they buying your products? What do they like? What don’t they like? What inspires them? What engagement activities resonated the most? This business intelligence can inform every part of your business, from how your supply chain works to creating better consumer engagement strategies.

Final thoughts

The purchase used to be the last part of your supply chain; now it’s the beginning of a new realm of possibilities. Every digital asset is an opportunity to connect your customers to your brand and put your products front and center in their lives.

rfxcel’s Traceability System is an end-to-end supply chain solution that creates the digital assets. It gives you in-depth, real-time insights all the way from production to your final customers. The data you connect to your products will fuel compelling consumer engagement activities that can reach people everywhere you do business.

And now, as part of Antares Vision Group, we can offer even more ways to engage with consumers. Contact us today to find out more.

 

BONUS CONTENT!

Last year, we did a piece called “Supply-Chain Traceability Is Building a New Kind of Consumer Kingdom.” Here’s an excerpt that ties into what we’ve said about an effective consumer engagement strategy:

In fact, consumers are not only thinking deeply about where the things they buy come from and what goes into making them, they are actually becoming a pivotal part of the supply chain itself. What’s more, they’re participating willingly and with gusto, demanding detailed information about the goods they purchase and even expecting to interact with products far beyond the point of sale. Just how far will they go to get what they want? More than 70% of customers say they’re willing to share their data in exchange for a more personalized experience, according to one recent survey.

Read the full article here.

Why Your Supply Chain Is Vital for Effective Consumer Engagement

Consumers are exposed to countless brand messages every day. They see an endless variety of product information and opportunities, from ads, promotions, friends, and influencers on social media to signage in brick-and-mortar stores and website pop-ups. This is consumer engagement.

Or is it? It’s easy to throw an ad or a video online and say you have a consumer engagement strategy. But there’s a difference between consumer engagement and effective consumer engagement — and believe it or not, it’s your supply chain that makes the difference.

But we’re getting ahead of ourselves. Today we’re looking at why consumer engagement has become a vital part of marketing strategies. Part II will get into why your supply chain is the key to effective consumer engagement. Let’s get started.

What is consumer engagement?

Consumer engagement is part of a larger marketing strategy with interlocking elements that support and complement one another. It’s often mentioned in the same breath as customer experience (a.k.a. CX or CEX) and user experience (UX). It is definitely part of brand protection, which we’ll be talking about in another blog series.

The goal of consumer engagement is to establish and maintain a connection with your customers. It is a sustained interaction between brand and customer. It is fueled by content such as videos, rewards programs, and games/contests, and on-demand product information, such as traceability data that proves that your product is what you say it is.

Top benefits of effective consumer engagement

Consumers are not the only ones who reap rewards from consumer engagement. You — your company, your brand, your bottom line — stand to gain a lot. Here are just a few examples:

You’ll promote stronger customer relationships

Your consumer engagement strategy should make your customers want to continue buying your product. Engaging customers across touchpoints and channels will increase the likelihood of forming stronger relationships with them. When you move beyond pitching only your products and begin adding value with activities and incentives, your consumers will be more inclined to turn to you when they plan to make a purchase. This allows you to develop a community of engaged loyalists who are willing to choose your brand, even if your products are more expensive than your competitors’.

You’ll get more (and better) customer feedback and insight

No matter the channel — an app, a social media platform, an email, a text message — consumers are more and more willing to share what they think about the things they buy and the experiences they have. With this valuable data about your customers, you can improve your products and product experiences and continue honing your consumer engagement strategy.

You’ll leverage personalized, proactive communication

Today, it’s all about personalization. You want to make your brand relevant to each person’s daily life. For example, if you have a product you know a consumer might find valuable, you can reach out proactively and help them understand its usefulness. You can promote a contest, a promotion, a rewards program — anything. When you communicate personally in this way, you create new value for your product while letting people know you’re interested in making their lives and product experiences richer and fuller. Artificial intelligence is likely to be the cornerstone of this type of fast, individualized consumer engagement.

You’ll build customer trust and loyalty

You don’t want your relationship with your customers to end after they purchase your product. You want them to be loyal to your brand. You want to position your brand as part of their daily lives. You want them to trust you. And you want them to tell others about you. By regularly engaging with customers — via their preferred communication channel or channels — you can demonstrate the benefits of your products. An effective consumer engagement strategy will also help you identify your customers’ concerns and determine what they care about. For example, do they demand to know where their foods come from? Are they concerned about sustainability?

This is where brand protection enters the picture. Consumer engagement is absolutely part of an effective brand protection strategy. Come back to our blog next week to read more about that!

Final thoughts

Consumer expectations are changing faster than ever before. Just talking about your brand and hoping that people notice it is not enough — you need to start interacting and incentivizing. This is the basis of all consumer engagement.

We covered some fundamentals today, but in Part II we’re going to get into the cool stuff: Why your supply chain is the key to effective consumer engagement. Without giving too much away, we’ll be talking about traceability, serialization, digitization, and data.

So check back soon. In the meantime, contact us with any questions or to schedule a short demo of our Traceability System. You can also read more about how we can help you take your consumer engagement activities to the next level.

Antares Vision Group to Showcase Its Ecosystem of Production and Supply Chain Management Solutions at CPhI Worldwide in Milan

The company is attending the exhibition with end-to-end solutions that connect quality, safety, and efficiency

Travagliato, Italy, November 9,  2021. Antares Vision Group, whose mission is to accelerate technological innovation and digitalization by connecting the physical and digital worlds with the integrated value chain, will be exhibiting its ecosystem of production and supply chain management solutions at CPhI Worldwide November 9–11 in Milan.

The digitalization of production systems and supply chains has become a fundamental element of guaranteeing opportunities for innovation in many industries. The ability to transform physical processes into data and information opens channels of communication among all stakeholders, ensuring safety, transparency, and sustainability of processes at every stage of the supply chain.

This will be a central topic at CPhI Worldwide, one of the most important international events for the pharmaceutical industry. Now in its 32nd year — and returning to Milan after 14 years — CPhI will be held at the Fiera Milano exhibition hall from November 9 to 11, with more than 800 exhibitors from 170 countries representing every facet of the industry’s supply chain.

Antares Vision Group will exhibit in Hall 10, Stand L30, P-MEC, highlighting the synergy of expertise from its companies with a unique ecosystem of technologies and benefits dedicated to the pharmaceutical supply chain. This complete and integrated ecosystem comprises solutions for production, including traceability, quality control with automatic visual inspection machines (the result of a multi-technological approach), and intelligent data management (Efficiency 4.0), and solutions for the end-to-end supply chain, from raw materials to production, from distribution to the hospital and the patient.

Emidio Zorzella, CEO and co-founder of Antares Vision S.p.A., said, “We are happy to once again exhibit at CPhI Worldwide. This is a premier industry event and the perfect occasion for us to highlight ourselves as a partner and single point of reference for all stakeholders in the pharmaceutical supply chain. Thanks to the experience and technological synergies within our Group, we offer an ecosystem of solutions to manage the quality and safety of products and will lead the digital transformation of supply chains.”

The collection and interconnection of data — quality, traceability, IoT devices, and data from each step of the supply chain — contribute to the construction of a transparent and complete supply chain of information that empowers every participant to know and verify the integrity and history of every product. Digital identities for each smart product and a transparency that generates trust: This is the power of Trustparency®.

About Antares Vision Group

Antares Vision Group protects products, people, and brands with inspection systems featuring 6,500 quality controls, track and trace software solutions for end-to-end transparency and visibility in digital supply chains, and smart data management tools for maximum operational efficiency, from raw materials to final consumers. It provides solutions to five primary industries: pharmaceuticals and life sciences (medical devices and hospitals), food and beverage, cosmetics, and consumer packaged goods. Active in more than 60 countries, Antares Vision Group has seven production facilities and three Innovation and Research Centers in Italy, 22 foreign subsidiaries, and a global network of more than 40 partners. Today, 10 of the world’s 20 leading pharmaceutical companies use its solutions to secure their production and supply chain operations; worldwide, it has deployed more than 25,000 inspection systems and more than 3,500 serialization modules. Antares Vision Group has been listed on the Italian Stock Exchange’s AIM Italia market since April 2019 and in the STAR Segment of the Mercato Telematico Azionario (MTA) since May 2021. www.antaresvisiongroup.com

Further information

Davide Antonioli, Antares Vision PR Specialist: davide.antonioli@antaresvision.com | +39 339 8124446

rfxcel, Part of Antares Vision Group, and MVC Sign Agreement with Lebanese Republic to Deploy End-to-End Pharmaceutical Traceability Hub

The agreement continues the partners’ success in the Middle East, where they recently launched the first GS1-compliant Traceability Hub in the Kingdom of Bahrain.

Reno, Nevada, Sept. 22, 2021 (EINPRESSWIRE). rfxcel, part of Antares Vision Group and a global leader in digital supply chain traceability solutions, today announced that it signed a five-year cooperative agreement with the Lebanese Republic’s Ministry of Public Health to provide a GS1-compliant Traceability Hub to secure the country’s entire pharmaceutical supply chain. The company will implement the system with its partner Medical Value Chain (MVC), the Bahrain subsidiary of U.S.-based AVC Global.

The announcement comes only a few months after rfxcel and MVC were selected by Bahrain’s National Health Regulatory Authority and Supreme Council of Health to provide the first GS1-compliant system to track the Kingdom’s entire pharmaceutical supply chain on a blockchain platform.

The Lebanon Traceability Hub will deliver end-to-end visibility into every aspect of the country’s pharmaceutical supply chain, from the manufacturer of origin, importers, wholesalers, and distributors to pharmacies, clinics, and hospitals — all the way to individual patients. It will integrate with the Ministry of Public Health’s MediTrack system for domestic manufacturers.

The Hub is designed to achieve the following:

  • Lower the cost of pharmaceuticals
  • Provide patients with only authentic, safe medications
  • Combat drug counterfeiting and smuggling
  • Ensure access to pharmaceuticals subsidized by the Banque du Liban, the central bank of Lebanon
  • Prevent hoarding of medicines

“The Hub is all about leveraging leading-edge technology to secure Lebanon’s pharmaceutical supply chain and safeguard patients and consumers,” rfxcel CEO Glenn Abood said. “Security and safety — these are the very reasons I founded rfxcel almost 20 years ago. We’re eager to begin our work with MVC in Lebanon, and we’ll continue to focus on bringing Traceability Hubs to other countries in the Middle East and beyond.”

MVC Co-Founder and President Leo Giacometto said, “The MVC technology platform with blockchain revolutionizes the delivery and integrity of pharmaceutical supply chains in Lebanon. We are excited and honored to deploy our platform in partnership with the Ministry of Public Health in the Republic of Lebanon.”

Emidio Zorzella, Antares Vision Group CEO, said, “We’re all eager to start working with the Ministry of Public Health and gratified that everything has come together so well. When we unveiled the Bahrain Traceability Hub in June, I said we’d be announcing national hubs in other countries. Here we are today, continuing our vision of protecting products and people, and making supply chains safer and more efficient.”

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, protect their products and brand reputations, and engage consumers. Blue-chip organizations in the life sciences (pharmaceuticals and medical devices), food and beverage, worldwide government, and consumer goods industries trust rfxcel’s Traceability System to power end-to-end supply chain solutions in 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

Antares Vision Group protects products, people, and brands with inspection systems featuring 6,500 quality controls, track and trace software solutions for end-to-end transparency and visibility in digital supply chains, and smart data management tools for maximum operational efficiency, from raw materials to final consumers. It provides solutions to five primary industries: pharmaceuticals and life sciences (medical devices and hospitals), food and beverage, cosmetics, and consumer packaged goods. Active in more than 60 countries, Antares Vision Group has seven production facilities and three Innovation and Research Centers in Italy, 22 foreign subsidiaries, and a global network of more than 40 partners. Today, 10 of the world’s 20 leading pharmaceutical companies use its solutions to secure their production and supply chain operations; worldwide, it has deployed more than 25,000 inspection systems and more than 3,500 serialization modules. Antares Vision Group has been listed on the Italian Stock Exchange’s AIM Italia market since April 2019 and in the STAR Segment of the Mercato Telematico Azionario (MTA) since May 2021.

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

Herb Wong, rfxcel Vice President of Marketing and Strategic Initiatives

Tel.: +1 925-791-3235

E-mail: hwong@rfxcel.com

3 Benefits of Supply Chain Traceability for Your Business

Imagine for a minute that you get the phone call all companies dread. It’s the “I am dissatisfied with my product” call, direct from a customer. You take the call, help the customer, and move on, right? You’re feel good about solving the problem — and are definitely not thinking about supply chain traceability.

A few days go by, then you’re flooded with more complaints, none of which seem to be related. You scramble to identify the root cause of all your problems, but you don’t know where to look. What should you do?

This is when you should be thinking about supply chain traceability. It is the key to having total insight into how your products get made, where they’ve been, and where they’re going. By employing supply chain traceability, you can:

  • Assure your brand and customers are protected
  • Maintain regulatory compliance
  • Pinpoint common problems, such as counterfeits and diversion

Let’s take a deeper look into each of these benefits.

1. Supply chain traceability for brand protection and customer satisfaction

Customers grade a brand on both the quality of its products and how it responds when an issue arises. Brands build loyalty with their customers by being transparent and demonstrating consistent product and service quality. Brands lose customers by failing to respond to complaints and recalls.

Response to complaints and recalls

Supply chain traceability is helpful when investigating a customer complaint. It is also essential when assessing a potential recall or managing an actual recall.

All the products you make and sell must have identification that traces back their source. Manufacturers and retailers can follow a problematic unit backward through its life cycle. Information collected through traceability includes:

  • Date and time of manufacturing
  • Equipment used for manufacturing and packaging
  • Personnel involved in manufacturing and packaging
  • Raw materials and components
  • Physical locations of inventory throughout its life

In a best-case scenario, the complaint is an isolated incident that’s easy to fix. But if the complaint means there’s been a breakdown somewhere or a product has been compromised, a recall may be triggered.

Recalls happen for any number of reasons. For example, you might discover a material that is out of specification. Once identified, it is necessary to trace all usage of that material. Another example is contamination, especially in the food supply chain.

A recall of any size can have a significant impact on your business. Having a supply chain traceability system will speed recalls, improve cooperation with regulators and other authorities, enable better information-sharing with your customers, and reduce damage to your brand reputation. Faster batch recalls are possible only when there is a robust supply chain traceability system.

Transparency about sourcing

A study conducted by the Consumer Goods Forum found that “70 percent of consumers are most interested in transparency about products.” Customers want to know where the materials used in their products came from and how they were sourced.

Some companies are publishing reports to make their supply chains and operations more transparent — and to make their brand more appealing to consumers. In addition to how they source materials, they’re sharing information about things such as:

  • Origins and purposes of raw ingredients
  • Manufacturing processes
  • Safe handling practices along the supply chain
  • The brand’s mission and values

This type of “transparency marketing” is effective in the food and consumer packaged goods industries, as it entices consumers to make a purchase because they’re getting the product information they demand.

A 2016 study by Label Insight indicated that 94 percent of consumers are not only likely to be loyal to a brand that offers complete transparency but are willing to pay more for products that meet such standards. This has powerful implications for brands; it shows that transparency made possible with supply chain traceability inspires product and brand loyalty.

2. Supply chain traceability is key to compliance

Being able to track material movement and consumption is critical for regulatory compliance.

The ISO 9000 Standards Series is the basis for most industries’ standards and provides expectations to help companies structure their quality management systems. Within these standards, traceability is defined as “The ability to trace the history, application, use and location of an item or its characteristics through recorded identification data.”

To meet this standard, it’s critical to be able to identify individual product units. Also, you must collect information about subcomponents. This information will allow for the tracing of parts of products throughout your supply chain.

Serialization makes supply chain track and trace easier

Serialization is the process of assigning unique identifiers to outbound and inbound materials. This makes the parts of products easier to track and trace throughout your processes. Utilizing software such as our Serialization Processing solution will save you time and effort in managing your supply chain.

Collecting supply chain data on your materials and finished products can also help to identify problems before they become an issue. This empowers you to be proactive and assess what works well (or what does not work well) throughout your entire supply chain process, which allows you to standardize your work processes and cut out waste.

Prove your product claims

Marketing claims must be substantiated, not only to consumers but also to regulatory agencies. Claims about sustainable sourcing, organic certifications, and other attributes can be demonstrated with supply chain traceability. Safe and compliant handling of products is also best demonstrated with traceability. Many retailers and manufacturers have routine audits to assure that they have processes to trace a product’s life cycle. In some industries, the results of these audits are available as public information.

Regulations evolve over time

Regulatory requirements for the documentation of traceability are constantly evolving. For example, the U.S. Food and Drug Administration (FDA) published the “Proposed Rule for Food Traceability,” which called for additional traceability records for certain foods. The FDA is encouraging the voluntary adoption of these new practices for all food products. These new requirements will affect all who manufacture, process, pack, or hold foods.

We’ve written extensively about the FDA’s push for traceability in modern food supply chain. For example, check out “Food Traceability Regulations in the United States: A Timeline.”

rfxcel is prepared to help you comply with all current and future requirements in any industry, including food and beverage, life sciences/pharmaceuticals, government, and consumer goods. We track industry regulations and guidance documents for upcoming and proposed legislation. We have software solutions that take the guesswork out of compliance no matter where you do business.

3. Combat counterfeits and diversion/theft by identifying supply chain weak spots

One of the worst things that can happen to any business is having their products counterfeited or stolen.

Counterfeits not only result in a direct loss of sales, but your customers might lose faith in your brand. If a person winds up with an inferior counterfeit product with your name and logo on it, there’s a good chance they will be dissatisfied with your brand and take their business somewhere else. And if your products are diverted or stolen, then you’re losing money and might have a much larger supply chain problem on your hands.

Supply chain traceability is like a forensic tool to help fight counterfeits and diversion — and host of other problems. Here’s how it works:

  • You know the origin of your ingredients. You can verify that all ingredients or components are legitimate. You can see the history of any ingredient, including its origin and when it was combined with other ingredients to make a finished product.
  • You can trace a product’s every move. Traceability means you can see everywhere a product has been before, during, and after it was harvested or manufactured. You can see every case or box, every pallet, every delivery vehicle, every stop along the supply chain (e.g., a warehouse, a retail store, a pharmacy or hospital). Even after a product has been unloaded from the delivery vehicle and taken out of cases or boxes, you see where individual units have been right up to the time the consumer takes possession (check-out at the cash register, dispensation at a clinic, etc.).
  • You can pinpoint where a product might have been harmed or compromised. Traceability data will show if a shipment strayed from its prescribed route, which could indicate theft or other mischief that could harm your bottom line and brand. Serialization, compliance, real-time monitoring, and other supply chain traceability solutions create a provenance that can demonstrate the legitimacy and purity of every product.

Final thoughts

We hope you have a better idea of how supply chain traceability can help your brand and business. Traceability is a crucial aspect of managing your business operations.

Are you ready to get started? Setting up your own supply chain traceability system might seem daunting, but rfxcel is here to help. We have easy-to-use, scalable solutions for all of your track and trace needs, no matter what industry you’re in.

Contact us today if you would like to see a short demo of how we can help you to build an effective traceability system. Together, we can protect your brand, ensure regulatory compliance, and fight counterfeits and theft.

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.

 

Saudi Arabia’s Traceability Requirements for Imported Food

The Kingdom of Saudi Arabia imports about 80 percent of its food, according to a June 2020 report from the U.S. Department of Agriculture. To prevent food-borne illnesses and increase visibility in the food supply chain, the Saudi Food and Drug Authority (SFDA) strictly regulates imported food.

Let’s take a look at what food companies must do to comply with SFDA regulations when shipping their products to Saudi Arabia.

Saudi Arabia’s requirements for imported food

The Department of Agriculture report lists the following import procedures. First, companies must create an “E-account” with the SFDA and register their food products. They must have a Commercial Register, which includes imports and distribution of food
products. They must also submit an original invoice certified by a chamber of commerce in their home country. Last, depending on the product being imported, the may be asked to present some of following certificates:

  • Certificate of origin (copy)
  • Halal certificate (original). A Halal certificate is proof that the product meets Islamic Law requirements and is acceptable for consumption in Muslim-majority countries, as well as Western countries with a large Islamic population.
  • Certificate of slaughtering for meat and poultry (original)

Other requirements for imported food items

The GCC Standardization Organization (GSO) was established in 2001 and began operations in 2004. It is exactly what its name says: a standards organization for Gulf Cooperation Council (GCC) members. GSO requirements for Saudi Arabia’s imported foods are listed below. Many of these regulations also apply to domestic food items.

GCC Standards Organization (GSO) 9/2007

Since the end of 2010, Saudi Arabia has enforced the Gulf Standard 9/2007. Per this standard, all prepackaged and domestic foods must at minimum contain the following data points:

  • Product name
  • Packer’s name
  • Country of origin or manufacture
  • Listing of ingredients
  • Instructions for use (if applicable)
  • Shelf life

GSO 2233/2018 requirements for nutritional labeling

In 2013, the SFDA began enforcing GSO 2233/2012, a regulation from the GSO that requires labels to clearly disclose a product’s nutritional information (e.g., calories, carbohydrates, proteins, and fats) that may affect its nutritional value and consumers’ health or safety. The labels must list the ingredients, and nutritional information must be presented in a standardized, easy-to-read table so customers can readily understand what they’re purchasing. The labeling is also designed to increase people’s nutritional education to improve overall health. Some products are exempt from labeling, including bottled water, fresh fruits and vegetables, one-nutrient foods such as rice and coffee, and foods for special dietary uses, including infant formula.

Final thoughts

Keeping up with food traceability and regulations in Saudi Arabia — or any market — is a challenge. But rfxcel can help. Our solutions for food and beverage cover everything from farm to fork, from compliance to environmental monitoringContact us to book a demo of our award-winning rfxcel Traceability System and see how this  customizable, scalable platform will simplify and accelerate all of your supply chain operations.