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DSCSA Compliance Library: Comprehensive DSCSA Information in One Location

Welcome to the rfxcel DSCSA Compliance Library. It’s a collection of our key DSCSA resources (as of September 2023) and is a convenient place to get information as the industry navigates the “extended stabilization period” until FDA enforcement begins on November 27, 2024.

We will, of course, continue writing about the DSCSA and providing the best supply chain solutions to ensure manufacturers, wholesalers, dispensers, repackagers, third-party logistics providers — all pharmaceutical stakeholders — meet the requirements and remain compliant forever.

So bookmark this page and our blog. You can also subscribe to our newsletter to make sure you don’t miss anything about the DSCSA and other important developments in the pharma industry. Just fill out the short form at the bottom of any page on our website.

And of course, contact us today with your questions about the DSCSA or anything else about the pharma supply chain. Our experts are here to help.

A note about the rfxcel DSCSA Compliance Library

Please note that that we haven’t included everything we’ve written or presented about the DSCSA. Deadlines and requirements have changed since the law was enacted in November 2013, so some of our earlier pieces are, logically, outdated.

The DSCSA in our blog

DSCSA compliance white papers

Our top DSCSA news items

­­Our top DSCSA webinars

The DSCSA timeline

A timeline showing key dates of the U.S. Drug Supply Chain Security Act (DSCSA) from 2013 to 2024

Uzbekistan Traceability: Advancing Supply Chain Transparency and Safety

Note about Uzbekistan traceability: On February 7, 2022 — just 10 days after we posted this article — Uzbekistan’s State Tax Committee announced that it was “extending the timeframe for the phased introduction of mandatory digital markings” for pharmaceutical products. The February 1 deadline is longer in effect for this product category. Read the details here.

 

On February 1, 2022, Uzbekistan traceability requirements for medicines and medical devices will go into effect. It’s the latest compliance deadline in the country’s push for serialization and digital marking regulations that will affect an array of industries. Here’s a breakdown of the law and the latest Uzbekistan traceability updates.

The Uzbekistan Traceability System: ASL BELGISI

The Uzbekistan traceability system is called ASL BELGISI. It’s managed by CRPT Turon, the equivalent of Russia’s Center for Research in Perspective Technologies (CRPT), which manages Russia’s National Track and Trace Digital System (Chestny ZNAK).

On November 20, 2020, the Uzbekistan government published Decree PKM-737, “Establishment of Obligatory Digital Labeling.” It mandates serialization for tobacco products; alcohol, including wine and wine products; beer and brewing products; appliances; medicines and medical devices; and water and soft drinks.

Furthermore, it requires supply chain participants to register with a national catalog of labeled goods; when an application is approved, the participant receives an account and is granted access to the system.

According to the CRPT Turon website, the “main task” of ASL BELGISI “is to guarantee consumers the authenticity and declared quality of the purchased products.” Like Chestny ZNAK, consumers can download a mobile app to scan products, report suspect products, and provide feedback about the system.

Marking requirements

Uzbekistan traceability requirements mirror those mandated in Chestny ZNAK. All domestically produced and imported goods must be marked with DataMatrix codes that are traced across the supply chain through a four-step process:

    1. CPRT Turon assigns a unique DataMatrix code to each product and the manufacturer or importer places it on the packaging.
    2. The product’s movements are traced throughout the supply chain, from the factory or point of importation to the consumer, via scanning of the DataMatrix code.
    3. Retailers scan the codes when products are stocked and sold.
    4. Consumers can use the ASL BELGISI app to check a product’s legitimacy (i.e., confirm that it’s not a counterfeit) and access product information.

To get DataMatrix codes, participants must be registered with ASL BELGISI, describe the goods in a national catalog of labeled goods, then formally order the codes and apply them to the products. The codes must be applied to packaging or a product label according to the ISO/IEC 16022-2008 “Automatic identification and data capture techniques – Data Matrix bar code symbology” specification. At present, each DataMatrix code costs 68 som (excluding VAT), which is quite literally a fraction of a U.S. dollar: $0.0063.

Like its Russian counterpart, ASL BELGISI uses “verification keys” and “verification codes.” These are also commonly known as crypto codes. CRPT Turon generates these codes.

Generally, the DataMatrix codes for products in every regulated industry must include four data points:

    • A 14-digit product code (i.e., Global Trade Item Number, or GTIN)
    • A 13-character randomized serial number generated by CRPT Turon or a supply chain participant
    • A four-character verification key generated by CRPT Turon
    • A 44-character verification code generated by CRPT Turon

For aggregation, a Serial Shipping Container Code (SSCC) number must be provided in a one-dimensional barcode following the ISO 15394:2009 “Packaging – Barcode and two-dimensional symbols for shipping, transport and receiving labels” specification.

Regulated industries and key dates/requirements

Uzbekistan traceability regulations currently apply to five product categories: tobacco; alcohol, including wine and wine products; beer and brewing products; appliances; medicines and medical devices; and water and soft drinks. Below, we list the latest information about each category.

Filter cigarettes

    • January 1, 2021: only labeled products may be produced and imported
    • July 1, 2021: manufacturers may ship only labeled products to wholesalers
    • October 1, 2021: distributors may ship only labeled products to retailers
    • January 1, 2022: sale of unmarked cigarettes is prohibited
    • October 1, 2022: mandatory labeling for all types of tobacco products

Alcohol

    • January 1, 2021: only labeled products, including wine and wine products, may be produced and imported
    • December 1, 2021: alcoholic beverages packaged in metal containers, including aluminum containers, must be labeled
    • December 1, 2021: aggregation required for alcoholic beverages, including wine and wine products
    • November 1, 2022: aggregation required for alcoholic beverages packaged in metal containers, including aluminum containers

Beer and brewing products

Mandatory labeling began on April 1, 2021.

Appliances

A pilot for appliances began on July 1, 2021. Mandatory labeling is being introduced in phases. Vacuum cleaners, refrigerators, freezers, washing machines, TVs, and monitors were required to be labeled beginning December 1, 2021.

Medicines and medical devices

    • June 1, 2021: 6-month pilot for medicines and medical devices begins
    • January 28, 2022: CRPT Turon announces that the pilot is officially closed
    • February 1, 2022: only labeled products may be produced and imported

CRPT Turon reported that, during the pilot, all participants successfully registered with ASL BELGISI and registered agreed-upon product in the national catalog of labeled goods. They also successfully installed marking equipment on production lines, trained employees to use the equipment, and released batches of properly labeled, serialized products.

More about the requirements for medicines and medical devices

In addition to a DataMatrix code that includes a 14-digit product code (i.e., GTIN), a 13-character randomized serial number, a 4-character verification key, and a 44-character verification code, packaging must have a human-readable GTIN, lot number, expiration date, manufacturing date, and serial number.

Digital marking must be applied directly to packaging on the production line in a “specially designated place” and not be larger than 10×10 millimeters. The codes must be affixed in a way that prevents them from being separated from packaging during the entire shelf life of the product. Codes may not be printed on external packaging material, including transparent film/wraps, and my not be obscured by other information.

Water and soft drinks

This product category includes bottled water, soft drinks, and fruit and vegetable juices.

    • June 1, 2021: pilot for water and soft drinks begins
    • March 1, 2022: only labeled products may be produced and imported

Final thoughts

In June 2021, CRPT Turon announced that it had issued more than 350 million codes, including more than 200 million for tobacco products, almost 130 million for alcohol products, and approximately 20 million for beer products.

As of today (January 28, 2022), it reports that it has issued nearly 583 million codes for tobacco products, more than 300 million for alcohol products, almost 143 million for beer products.

These figures illustrate a simple fact: Strict serialization and traceability regulations are here to stay in Uzbekistan. Russia has led the way with Chestny ZNAK, which arguably has the world’s toughest supply chain requirements, and we should watch the regulatory landscape in the other Newly Independent States (NIS) — Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, and Ukraine.

As we said above, ASL BELGISI, the Uzbekistan traceability system, mirrors Russia’s Chestny ZNAK. rfxcel is an undisputed leader in Chestny ZNAK compliance. Consider these facts:

  • We’re an official CRPT partner for medications, bottled drinking water, tobacco, footwear, tires, light industry, perfumes, dairy, bicycles, and wheelchairs.
  • We’ve demonstrated to the CRPT that our solutions for traceability and compliance meet its stringent requirements.
  • We’re accredited as an IT company by Russia’s Ministry of Digital Development, Communications, and Mass Media.
  • We’re one of the few providers with active implementations in Russia (e.g., major global consumer goods and pharmaceutical companies).
  • We have an ever-growing Moscow-based team that knows the regulations and brings expertise in key areas of supply chain management and technology.
  • We’ve led the way in thought leadership with white papers and industry updates and information. (See the list below for a sample.)

We’ve also developed end-to-end traceability and compliance hubs for governments that want to lock down their supply chains with the best digital technologies and solutions. Read more about those here and here.

Contact us today to learn more about our traceability and compliance solutions. Our digital supply chain experts will share a short demo of our award-winning Traceability System and show you how to remain compliant and agile no matter where you do business.

A sample of our Chestny ZNAK coverage:

 

Wine Consumer Engagement: Ten Things to Know for 2022

Virtual tastings are so 2020. Don’t get us wrong: They’re still a thing. But to do wine consumer engagement right in 2022, winemakers have to do a lot more than ask people to hop on a Zoom call. That’s why today we’re talking about 10 things that are vital to successful wine consumer engagement.

Also, don’t forget that the Unified Wine and Grape Symposium starts today! We’ll be exhibiting with our fellow Antares Vision Group member companies FT System and Applied Vision, so sign up today and visit us at Booth 807.

Ten things to know about wine consumer engagement in 2022

Like our recent “Five Wine Supply Chain Trends for 2022” and “Trends for the Digital Wine Supply Chain” blog posts, we’re not ranking these aspects of wine consumer engagement. They’re all important. Winemakers should consider each carefully when crafting their engagement strategies.

1. Nail your story

Your brand’s story is vital to wine consumer engagement. (All consumer engagement, actually.) It’s the foundation of “the face” and the heart of the personality you’re going to project to your customers and potential customers. What do you want people to know about you? Where is your brand “coming from”? What sets you apart from other brands?

Many of the other aspects of wine consumer engagement we’re discussing today stem from and overlap with the decisions you make about your story. To get this right, expect to do some soul-searching and ask yourself some tough questions about who and what your brand is.

2. Know your customers

It’s Marketing 101, right? If you don’t know who’s buying your products, you’re missing opportunities and wasting money. Today, however, knowing your customers requires elbow grease. You have to devote time and resources to gather information (i.e., data) and develop profiles to inform your wine consumer engagement.

Here’s a handy tool: ALE. It’s an appropriately wine-and-spirits-flavored abbreviation for ask, listen, and engage. Ask consumers questions. Listen — really listen — to their answers, feedback, suggestions, opinions, etc. Importantly, what they say might not jibe with your own vision of your brand, so be willing to adapt and pivot and do the extra work to give people what they want, not what you want them to want.

To engage, pull out all the stops. Social media, of course. But you can also get out into the real world. Talk with sommeliers to see what’s trending with wine lovers. Talk with retailers to learn what people are thinking and buying. For instance, is there a cheaper brand that people are being drawn to? What brands have buzz?

We all know that wine can be a very personal experience. It’s part of its appeal. It’s why people get excited about wine and anticipate the purchase as much as the uncorking. Take advantage of that. Ask, listen, and engage.

3. Customer first, brand second

So, you’ve done the research and know who your customers are. Time to let them know all about your brand, right?

Not really.

Always remember that wine consumer engagement is about the consumer. They are the hero, not you. It can be a difficult lesson to learn, but your job is to guide people toward what they want and demonstrate the value your brand brings. Don’t make it all about you, because it’s not. Give people what they want to see and share, not what you want to show them.

4. Accept that you might not be that special

This might sting. You have to be self-aware. You have to know your strengths and weaknesses. You have look in the mirror and do an honest self-assessment.

What, if anything, makes you unique? Remember, unique means unlike anything else. One of a kind. Are your competitors saying they’re unique while making the same claims you’re making?

Industry observers are noting that wineries are saying the same thing. “Estate-grown,” “multi-generational,” “visionary winemaker,” and “terroir” are on their short list of traits and lingo that are decidedly not unique in the market. You can talk about these things, but don’t pin your identity on them.

Knowing your customers is what will make your brand stand out. What do they like (and dislike) about your wines? Where do they drink your wines? How do they “use” your wines? Are they talking about and sharing your wines on social media? What do they expect from you? Meeting their demands is what will make your brand special.

5. Be yourself

All this said, it is critical to be yourself. Don’t put on airs. Don’t pretend to be something you’re not. Don’t be a bore. Today’s consumers have a nose for you-know-what. If they get even a whiff of phoniness, watch out. So, you have to be authentic. Keep it real.

6. Focus on sharing

Think of wine consumer engagement as a self-perpetuating chain in which the links are interactions, including sharing between and among your customers. For this to happen, you have to create content that people want to see, experience, and share. The possibilities are virtually limitless — videos, contests, loyalty programs, giveaways, prizes … . Just remember to focus on your consumers, not yourself.

7. Always bring value to consumers

Ask yourself this question every day: What have you done for them lately?

You must always bring value to your customers. “ABV” — another industry-appropriate abbreviation. This means different things to different people, of course. For some, it might mean proving the provenance of your wines and demonstrating that you’re focused on transparency and sustainability. For others, it could mean sharing a picture of your team out in the vineyard or a fun promotion, such as winning a prize for sharing a video. If you’re not always bringing value to your customers, who are the heroes of your wine consumer engagement, you’re going to push them away.

8. Devote resources

Wine consumer engagement isn’t a “set it and forget it” proposition. It shouldn’t be an afterthought delegated to whoever might happen to have some spare time.

You need a person or a team to conceptualize and create content, push it out across all your channels, monitor and analyze reactions, make changes, and respond to what people are saying and asking. You also need to pay attention to what your competitors are doing and saying.

In other words, you have to be fully engaged in your consumer engagement.

9. Business as usual probably won’t cut it

It’s a cliché because it’s true: You have to think outside the box. Running an email campaign* or posting a video on Facebook then kicking back with a nice Pinot to watch your sales boom isn’t how wine consumer engagement works. It’s called consumer engagement for a reason: You want to get a response. You want to build that self-perpetuating chain of interactions. Creativity is key. It’s another reason to devote resources to make sure you’re doing it right.

*A note about email and marketing: Some people say it’s dead; others say it’s alive and well. Only you can decide if it works for your brand and if it should be part of your consumer engagement strategy.

10. Leverage supply chain data

We’ll let you in on our secret: The key to effective wine consumer engagement is your supply chain, which is a goldmine of actionable data.

The basic building block is serialization, which turns every product into what we call a “digital asset.” 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. For example:

    • Link every product to unique content and brand interactions
    • Give consumers the information they demand (e.g., provenance, transparency, sustainability)
    • Hyper-personalize and hyper-target every engagement based on location, time, or purchasing data
    • Empower consumers to reject counterfeits, alert for diversions/gray markets, authenticate products, help with recalls
    • Gain valuable insight into your customers

Final thoughts

“A message in every bottle.” This is rfxcel’s mantra for using your supply chain for wine consumer engagement. Our Traceability System provides granular data from the vineyard all the way into your customers’ daily lives. You can use it to define and tell your story, know your customers and bring them value, and inspire your brand to think outside the box.

If you’re at the Unified Wine and Grape Symposium this week, stop by Booth 807 to see our solutions in action and learn more about how we can help your brand stand out in a very crowded market. If you aren’t there, contact us today to schedule a short demo with one of our digital supply chain experts.

And be sure to read our other articles about the wine supply chain and why your supply chain is vital for effective consumer engagement and brand protection:

Cosmetics Supply Chain Challenges in 2022

In our last two blog posts of 2021, we talked about the global problem of counterfeit cosmetics and who investigates them when they’re discovered. For our first article of 2022, we’re talking about cosmetics supply chain challenges the industry should consider as we make our way through what will likely be another trying year for the global supply chain.

Please note that this isn’t a ranked list or a “countdown” to the No. 1 cosmetics supply chain challenge. That said, let’s get started.

Five Cosmetics Supply Chain Challenges

Counterfeits and fakes

Yes, we’ve been talking about counterfeits a lot lately. But they’re one of the cosmetics supply chain challenges that bears repeating and re-emphasizing. Cosmetics and perfumery products are consistently among the Top 5 products “targeted by counterfeiters,” with fakes accounting for just under 10 percent of all customs seizures in 2019.

There are two main reasons why counterfeits are a challenge. First, they are a public health threat because they can contain hazardous materials. Second, they are a major threat to companies’ brand security. Traceability in a digital supply chain, including serialization and real-time environmental monitoring solutions, is your best defense. Read more in our brand protection blog series.

Sustainability

Sustainability is top of mind for all supply chain stakeholders. Consumers are one of the main drivers here, as they’re demanding accountability from the brands they buy. And if they don’t get it, they’re happy to take their business elsewhere. More and more regulatory bodies are also calling for sustainability.

Traceability, visibility, and transparency are how you can prove to consumers and regulators that you’re operating a sustainable supply chain with environmentally friendly/conscious processes and products. We wrote a good summary about “The Trifecta” of traceability, visibility, and transparency in our “Top Supply Chain Trends of 2021” post. Read that for more details about this important trend.

Refrigeration/Climate control

Some cosmetics must be shipped at specific temperatures. If the temperature dips or rises beyond that specified point — an event known as an excursion — products can be damaged, resulting in loss of revenue and, possibly, a knock to your brand reputation. This is a risk that’s simply not worth taking.

Climate control should be part of a larger real-time environmental monitoring solution. We call ours Integrated Monitoring. It’s an Internet of Things (IoT)-enabled solution that seamlessly integrates with your supply chain to monitor more than a dozen conditions, including temperature, on land, sea, and air.

Ethical considerations

One of the first cosmetics supply chain challenges is sourcing high-quality ingredients. (Indeed, this is a challenge in most industries; the concerns here should be on everyone’s radar.) In addition to the ethics involved in creating and maintaining a sustainable, environmentally friendly supply chain, cosmetics companies must contend with the issues of child labor and trafficked workers —even slavery.

To illustrate: mica and palm oil. The former is a sparkling mineral used in eye shadow, lipsticks, and highlighter; the latter is used for moisturizing or texture effects.

A 2016 report from the Amsterdam-based nonprofit Centre for Research on Multinational Corporations (SOMO) found that more than 20,000 children are forced to work in mica mines while their families live in severe poverty. Similarly, palm oil, the global market for which is expected to reach a global value of $57.2 billion by 2026, is plagued by human rights problems.

Companies must be vigilant. A digital supply chain with end-to-end traceability, visibility, and transparency is crucial.

Market changes

The cosmetics industry must continue to address changes in three areas: technology, regulations, and consumer sentiment. Of course, these changes are happening within the context of the pandemic, which arguably makes them more challenging.

In “The Global Cosmetics Market”, a white paper we published at the end of 2021, we get into the details of these challenges. Here are the broad strokes:

    • Technology is changing how consumers buy products and even how they interact with them. To adapt, companies can employ tools such digitalization and IoT devices to expand their supply chains without compromising efficiency.
    • Regulations are an ongoing concern in every industry. For example, in the United States, the Personal Care Products Act, if passed, would amend the Federal Food, Drug, and Cosmetic Act and give the Food and Drug Administration more oversight of production and authority over cosmetics products, including the power to demand recalls.
    • Everchanging consumer sentiment means cosmetics companies must pay attention to what people want, expect, and demand. This makes supply chain traceability, visibility, and transparency vital to success.

Final thoughts

We ended our “Top Supply Chain Trends of 2021” blog post with a questionnaire. These questions absolutely pertain to cosmetics supply chain challenges:

    • Are you keeping up with the trends we talked about today?
    • Are there gaps and blind spots in your supply chain?
    • Are counterfeits a problem in your industry?
    • Are you doing everything you can to protect your brand?
    • Are you actively reaching out to your customers to bring them closer to your brand?
    • Are there compliance deadlines on the horizon?
    • Are you certain your current supply chain solutions are truly optimal?
    • Are you using your supply chain as a strategic asset?

We encourage you to contact us to discuss why your supply chain is the key to keeping up with challenges. Our digital supply chain experts can share a short demo of our award-winning Traceability System that will clearly show why it’s the best solution for cosmetics companies.

We also encourage you look through our blog. To learn more about how transparency works, for example, read our “Transparency Trilogy,” which unpacks transparency in the global seafood supply chain. You can also subscribe to our quarterly newsletter, which tracks the latest news and trends in traceability, regulations, and other industry news. Find the subscription form at the bottom of any page on our website.

Who Investigates Counterfeit Cosmetics Products?

In our last blog post, we talked about the global problem of counterfeit cosmetics. Today, we’re talking about who investigates counterfeit cosmetics products, starting with how cosmetics are regulated in the United States and the EU.

Regulation of cosmetics products varies greatly from country to country, so our discussion today should not be taken as an overview of what to expect everywhere cosmetics are sold. Enforcement of laws and the actions authorities take to target counterfeits also vary.

What is universal, however, is that the cosmetics industry faces unique challenges with consumer safety, increased consumer demand for transparency, and being targeted by counterfeiters. It’s good to know who investigates counterfeit cosmetics products and what measures you can take to be part of the solution.

Who investigates counterfeit cosmetics products: USA and EU

Counterfeit cosmetics are dangerous because the criminals who make them don’t follow regulations or standards for production. Fakes are often contaminated with “stuff” you really don’t want to think about, let alone put on your face, such as bacteria, animal and human feces, arsenic, and mercury. So, regulators keep an eye on cosmetics.

United States

In the United States, the Food and Drug Administration (FDA) is the governing body for cosmetic regulations. Cosmetics products do not require FDA approval — but they are regulated. The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) explain the FDA’s requirements, restrictions, and disciplinary actions regarding cosmetics.

The FDA focuses on preventing adulteration and misbranding, mislabeling, and harmful ingredients or drugs. Adulteration refers to products or product ingredients that are not in line with FDA regulations or that have been contaminated. A misbranded product is “improperly labelled or deceptively packaged,” which could include counterfeit cosmetics products. The FDA prohibits 11 chemicals from being used in cosmetics products.

Additionally, the FDA reserves the authority to request recalls and work with the Department of Justice, Federal Bureau of Investigation (FBI), and Border Customs if any violations are found. It maintains a “Cosmetics Recalls & Alerts” page and has a searchable “Enforcement Report” database of recalled products.

The European Union

Cosmetics products manufactured in and imported to Europe are regulated under the EU Cosmetic Regulation. Like the FDA, the EU regulates ingredients and labeling; generally, however, the regulations are broader and more precisely defined.

For example, more than 1,300 substances (e.g., chemicals, colorants, and preservatives) are banned from cosmetic use, and hundreds more are permitted only under certain conditions. The regulations also mandate Good Manufacturing Practices (GMP), whereas the FDA only suggests GMP as “guidelines for effective self-inspection.”

Furthermore, the EU requires significant product documentation. Every cosmetics company must have a “responsible person” for every product they make. This person is responsible for ensuring products are safe and comply with regulations, and must submit a cosmetics product notification through an online portal before a product can be sold.

The responsible person must also create a product information file that includes the name, description, and nature of the product; description of the manufacturing methods; statement of compliance with regulations and GMP; a product safety report; and data about animal testing, if any. They must also assemble a product safety report that contains product safety information and a product safety assessment.

Do consumers have a role?

Yes, and it begins with vigilance with prices, packaging, and product quality:

      • Prices: If the price is too good to be true or just noticeably cheaper than the last time you bought it, there’s a good chance it’s a fake.
      • Packaging: The printing might look shoddy or the colors might seem off. There might not be a barcode. There might not be packaging at all, and the products might be offered in bulk.
      • Product: If the consistency or texture seem different, it’s likely a fake

In the United States, consumers can “report suspicions concerning the manufacture or sale of counterfeit or pirated goods” to the FBI. For suspected counterfeit cosmetics products seen online, consumers can contact the FBI Internet Fraud Complaint Center. The FBI has also partnered with the National Intellectual Property Rights Coordination Center to create a tip line where consumers can report products they suspect to be fake.

In the EU, consumers are encouraged to contact their local authorities about counterfeit cosmetics products. Depending on the nature of the situation, the authorities might investigate themselves or contact the appropriate investigative body, which could include Europol. The United Kingdom has Action Fraud, an online reporting tool for fraud and cybercrime.

Consumers should also be aware of what brands are doing to combat counterfeits and consumer engagement programs that encourage people to report suspicious products.

Final thoughts

If you really want to drill down into the U.S. and EU regulations, download our “Global Cosmetics Market” white paper today. It also has a section about regulations in Singapore, plus more information about counterfeit cosmetics products.

In “Top Supply Chain Trends of 2021,” we posed some important questions companies should ask themselves as we move toward what is likely to be another challenging year for supply chains. Many of those questions, listed below, fit perfectly with what we talked about today — regulations, counterfeits, brand protection, consumer engagement.

Your supply chain is where all of these concerns converge. Which is why you should schedule a short demo of our solutions. In about 15 minutes, we can show you the basics of our Traceability System and how it transforms your supply chain into a strategic asset that will improve and protect every facet of your business.

 

  • Are you keeping up with supply chain trends?
  • Are there gaps and blind spots in your supply chain?
  • Are counterfeits a problem in your industry?
  • Are you doing everything you can to protect your brand?
  • Are you actively reaching out to your customers to bring them closer to your brand?
  • Are there compliance deadlines on the horizon?
  • Are you certain your current supply chain solutions are truly optimal?
  • Are you using your supply chain as a strategic asset?

Addressing the Concern: The Threat of Counterfeit Cosmetics

Counterfeit cosmetics have boomed during the pandemic. Not that they’ve ever not been in fashion among the criminal set. But recent research shows a renaissance, a proliferation of often dangerous fakes readily available to more people and through newer channels.

We just published a white paper about the global cosmetics market. It has a section about counterfeit cosmetics, and now we want to keep the conversation going with more information about this global problem. Here we go.

The statistics reveal “a worrying threat”

In “Global Trade in Fakes: A Worrying Threat” (June 2021), the Organisation for Economic Co-operation and Development (OECD) reported that the global value of counterfeits and pirated goods amounted to as much as $464 billion in 2019, or 2.5 percent of world trade.

Worldwide, there were “consistently” more than 130,000 customs seizures of counterfeit and pirated goods annually in 2017, 2018, and 2019. “Overall,” the report continues, “the unified database on customs seizures of IP-infringing goods includes almost half [a] million observations.”

In 2017 and 2018, counterfeit cosmetics and perfumery products accounted for about 4 percent of all customs seizures. That rose to just under 10 percent in 2019 — a considerable jump in a very short time. Furthermore, cosmetics and perfumery products were among the Top 5 products “targeted by counterfeiters” every year from 2011 to 2019. (The others were articles of leather, clothing, footwear, and watches.)

What toll do counterfeit cosmetics take on the industry’s fiscal health? One report shows that annual sales losses from counterfeiting in cosmetics and personal care products sector amounted to 4.7 billion euros, or about $5.3 billion.

Our brand protection series talks more about counterfeits. It’s a real problem that every industry, some more than others, must contend with.

Counterfeit cosmetics in a huge global market

According to a Fortune Business Insights report published in September, the cosmetics market was worth $277.67 billion in 2020. Despite an overall decline in sales during the pandemic, the market is projected to grow to $415.29 billion by 2028.

The market has responded to consumer demand for a wider variety of products, and online shopping has added an ease of access. Online shopping will drive the market and, according to industry watchers, could account for nearly 30 percent of global beauty sales by 2026.

However, the dramatic shift from in-person to online purchasing during the pandemic has emboldened criminals to churn out more and more counterfeit cosmetic products. As OECD put in its “Global Trade in Fakes” report, “Under confinement, consumers turn to online markets to [fulfill] their needs, driving significant growth in the online supply of a wide range of counterfeits.”

Research from the U.S. Department of Homeland Security supports this finding. Its “Combating Trafficking in Counterfeit and Pirated Goods” report (January 2020) noted that “Selling counterfeit and pirated goods through e-commerce platforms and related online third-party marketplaces is a highly profitable venture.”

The threat to businesses and consumers

Counterfeit cosmetic products are a real threat to manufacturers and consumers. The bogus goods mimic the original, undercutting company sales. They bypass quality control processes and regulatory oversight, which means they can contain harmful “ingredients.”

For example, in 2018 authorities in the United Kingdom recovered counterfeit cosmetics that were found to contain mercury and high levels of hydroquinone, a skin-whitening agent. UK Police have also warned consumers about fake products containing “rat droppings, human urine, and arsenic.” Police in Los Angeles found counterfeits with bacteria and animal waste.

With the surge in online orders, shipping has become important to the counterfeit industry. The OECD reported that between 2017 and 2019, 64 percent of global seizures were postal shipments and 13 percent involved express couriers. In the same period, 77 percent of all counterfeits seized by authorities were discovered during the shipping period.

Final thoughts

Counterfeit cosmetics — counterfeit anything — threaten consumer safety and brand reputations.

Your supply chain is your first line of defense. With the right solution for end-to-end traceability, like our rfxcel Traceability System, you can leverage data and lock down your supply chain guard to against counterfeits and help mitigate other risks.

You’ll also be able to meet consumer demand for transparency. You can tell them with certainty that your products are what you say they are. You’ll ensure product safety and protect your brand.

If you have questions, we can help. Take a look at our solutions for brand protection and download our white paper about the global cosmetics market. And contact us today to arrange a short demo of our Traceability System. In about 15 minutes, our supply chain experts can show how our solutions will turn your supply chain into your most valuable strategic asset.

Top Supply Chain Trends of 2021

The supply chain has been grabbing headlines since the pandemic began, but this year was especially newsworthy. From flotilla-like bottlenecks at major U.S. ports to warnings about counterfeit toys in Santa’s sleigh, it’s been a challenging time for supply chain stakeholders and consumers alike. So, as the year winds down, we thought we’d take a look at some of the top supply chain trends of 2021.

The year’s supply chain trends

Before we start, please note that this isn’t a ranked list or a “countdown” to the No. 1 supply chain trend of the year. It’s just a collection of trends that have occurred in different industries and that have made industry news as we’ve worked our way through the year. That said, without further ado, here are the top supply chain trends of 2021.

Automation

Automation includes robotics, machine learning, artificial intelligence, process mining, drones, and driverless delivery systems. This trend dates back to the first half of 2019, when companies in North America spent $869 million on more than 16,000 robots. This year, the World Robotics 2021 Industrial Robots report said there were 3 million industrial robots operating in factories globally, a record number and an increase of 10 percent. The report also said sales of new robots grew 0.5 percent, with 384,000 units shipped globally in 2020.

Blockchain

Blockchain has been a buzzword for years, and worldwide spending on the technology has been predicted to reach more than $11 billion by 2022. In regard to supply chain management, blockchain has great potential for traceability because it allows the provenance of any product to be easily demonstrated with and supported by immutable, tamper-proof data. It’s a big topic, so download our “Blockchain-Based Supply Chain Traceability” white paper to learn more.

Sustainability

There’s been a barrage of research about supply chain sustainability, particularly consumers’ expectations for transparency and environmentally friendly products and packaging. In one recent survey, 83 percent of respondents said it was “important or extremely important” for companies to design environmentally conscious products. Another found that 81 percent of shoppers say transparency is important or extremely important to them. In short, more companies are choosing to make their supply greener and more transparent.

Consumer engagement/customer experience

Consumer engagement and customer experience have always had a place in marketing and branding, but they’ve risen to a priority position over the last several years. (See a tidy summary of why here.) But what does your supply chain have to do with any of this?

The short answer: Your supply chain is a gold mine of information that can be leveraged for robust, innovative engagement/experience strategies. The basic building block is serialization. Read our two-part series to learn more. And definitely read our article about how supply chain traceability is building a “consumer kingdom.”

“The Trifecta”: Traceability, Visibility, Transparency

It should come as no surprise that we’re including these three “must-haves” on our list of the top supply chain trends in 2021. We’ve always maintained that visibility, transparency, and traceability are the key to a successful supply chain; however, the last two years have shown us that this trifecta is more important than ever and is the best way to optimize, safeguard, and leverage your supply chain for business value.

Visibility means using data to gain insight into how your supply chain is functioning and to take steps to make it run more efficiently. The goal is to see every ingredient/input, every product, every partner, every handoff … everything. Transparency means communicating supply chain knowledge internally and externally so all stakeholders, including consumers, can see how you operate. Traceability means you can follow a product to its point of origin and prove what it is and where it came from.

We have written extensively on these topics. Here’s a suggested reading list:

Internet of Things (IoT)

IoT is a network of physical objects that connects to the internet via sensors and software. It’s the basis of our Integrated Monitoring solution. It enables greater visibility and flexibility across your entire supply chain. For example, IoT-enabled sensors placed in a shipment of vaccines will send a real-time alert if a problem arises, such as a temperature excursion or route diversion. We’ve written about IoT in the food and beverage industry, and rfxcel CEO Glenn Abood wrote a great article about real-time monitoring in the pharma cold chain. We also have a great video about it.

Digitization

If we were ranking the 2021′ supply chain trends, we’d make digitization No. 1. A supply chain that isn’t digitized cannot function efficiently. It cannot give consumers what they demand. It cannot comply with regulations. It cannot compete. It cannot make your business better.

Final thoughts

As we move toward the New Year, it’s a good time to think about the future of your supply chain. Ask yourself some basic questions:

    • Are you keeping up with the trends we talked about today?
    • Are there gaps and blind spots in your supply chain?
    • Are counterfeits a problem in your industry?
    • Are you doing everything you can to protect your brand?
    • Are you actively reaching out to your customers to bring them closer to your brand?
    • Are there compliance deadlines on the horizon?
    • Are you certain your current supply chain solutions are truly optimal?
    • Are you using your supply chain as a strategic asset?

The next step is to contact us. Our digital supply chain experts can share a short demo of our award-winning Traceability System that will clearly show why it’s the best solution for any business, under any circumstances.

Understanding GS1 Barcodes in the Global Supply Chain

Where would we be without standards? One thing’s certain: Your supply chain would be a lot messier, if not chaotic if you and your partners didn’t have a “common language” to process and exchange data. Standardized GS1 barcodes are one way we avoid this chaos.

GS1 barcodes keep everybody “on the same page.” They allow companies in virtually every industry to easily record, store, and transfer data. We’ve all seen them, and chances are your organization uses them — maybe even millions or billions of them. But let’s do a quick refresher course as another way to keep us all on the same page.

What is GS1, and why does everyone use GS1 barcodes?

GS1 is an international not-for-profit organization that develops and maintains a broad set of global standards used by businesses the world over. Of the various standards created by the organization, the GS1 barcode is undoubtedly the most well-known. Everyone from Amazon to eBay follows GS1 barcode standards, as these regulations help them easily share additional information about products with consumers and retailers.

A group of U.S. grocery retailers founded GS1 in 1973. Simultaneously, they created the first barcode labels. Since its inception roughly 50 years ago, GS1 has established itself as the leading authority on product identification regulations.

While GS1 general specifications have evolved over the years, the mission behind GS1 has remained unchanged. The organization is committed to promoting operational efficiency and supporting the sharing of information. It does so by providing e-commerce businesses, distributors, manufacturers, and retailers with an easy-to-follow set of labeling standards.

In 2023, GS1 barcodes are contributing to the proliferation of the global commerce ecosystem. Standardized produce labels like barcodes transcend borders, language barriers, and currencies. They enable members of the supply chain to interact on a worldwide scale to the benefit of consumers everywhere.

Why are GS1 barcodes important?

The short answer is, as we said above, standardized GS1 barcodes allow us to maintain order and avoid chaos. Workflows become quicker and more efficient. The GS1 barcodes keep supply chains running by enabling companies to sell, ship, track, reorder, and return products, in most cases by scanning with a handheld device or a camera-based system.

GS1 barcodes also expedite communication, traceability, visibility, and transparency. It’s really all about sharing information quickly in order to know the source of ingredients/components and products, where they’ve been and where they’re going, and when they reach their final destination.

These capabilities not only make supply chains more efficient — they also increase product safety and protect consumers. If there’s a recall, for example, a company can locate its products quickly, make sure shipments are stopped, remove items from stores, and share data with regulators and even consumers.

GS1 barcodes also save money. Administrative costs come down when everybody uses the same standards and has the same expectations. And because GS1 barcodes facilitate digital supply chains, they increase speed and reduce paperwork.

The bottom line is that GS1 barcodes provide members of the supply chain with easy access to product data. In turn, distributors, carriers, and retailers use barcode graphics to trace products throughout the supply chain, optimize operational efficiency, and ensure that consumers are receiving safe and authentic products.

GSI Identification Keys

GS1 standards define a set of unique identification codes, known as identification keys. GS1 says its identification keys “refer unambiguously to a real-world entity,” such as a product, a logistics unit, a physical location, a document, a service relationship, or another entity.

In other words, the ID keys let you quickly and conveniently access information about items in your supply chain and share it with your partners. Only GS1 members can build ID keys, which must include a GS1 company prefix. There are 12 ID keys:

        1. Global Trade Item Number (GTIN): identifies products and services, such as food and clothing
        2. Global Location Number (GLN): identifies parties and locations, such as companies, warehouses, factories, and stores
        3. Serial Shipping Container Code (SSCC): identifies logistics units, such as parcels and palletized products
        4. Global Returnable Asset Identifier (GRAI): identifies returnable assets
        5. Global Individual Asset Identifier (GIAI): identifies assets, such as equipment used in manufacturing and transportation
        6. Global Service Relation Number (GSRN): identifies relationships between service providers and recipients, such as hospital staff and members of brand “loyalty” or rewards programs
        7. Global Document Type Identifier (GDTI): identifies documents, such as shipping paperwork
        8. Global Identification Number for Consignment (GINC): identifies consignments, such as logistics units being transported in a container on a ship or airplane
        9. Global Shipment Identification Number (GSIN): identifies shipments
        10. Global Coupon Number (GCN): identifies coupons
        11. Component/Part Identifier (CPID): identifies components and parts
        12. Global Model Number (GMN): identifies a product’s model number

The GS1 standards also encompass data capture, including definitions of barcode and radio-frequency identification (RFID) data carriers, that allow ID keys and other data to be affixed directly to an object. Data standards also address the hardware to read and produce barcodes (e.g., scanners and printers), and hardware and software to connect the barcodes and RFID tags to business applications.

The different types of GS1 barcodes

All GS1 barcodes are “containers” that can hold different amounts information, such as serial numbers, batch numbers, GTINs, and expiration dates. As the image below from GS1 shows, there are four types, or “families,” of barcodes: EAN/UPC, two-dimensional (2D), DataBar, and one-dimensional (1D).

GS1 barcodes

EAN/UPC family. GS1 says, rightly, that these “are printed on virtually every consumer product in the world.” They are characterized by a series of vertical lines and a horizontal row of numbers, and come in four types: UPC-A, EAN-13, UPC-E, and EAN-8.

These GS1 barcodes are designed to be used at the point of sale and can be read by omnidirectional scanners. None support attributes — they cannot contain product information such as an expiration date, a batch number, or item weight. UPC-A has 12 numbers and supports GTIN-12; EAN-13 has 13 numbers and supports GTIN-13; UPC-E has 12 numbers (the zeros are “suppressed) and supports GTIN-12; and EAN-8 has 8 numbers and supports GTIN-8.

2D barcodes. Like EAN/UPC barcodes, 2D barcodes are ubiquitous. They are incredibly robust, able to hold dense product information and remain legible at greatly reduced sizes or when they’re etched into a surface, such as a plastic bottle cap. There are two kinds of 2D barcodes:

      1. GS1 DataMatrix codes are omnidirectional and support attributes and all GS1 ID keys. They can hold 3,116 numeric or 2,335 alphanumeric characters.
      2. GS1 QR codes are also omnidirectional and support attributes and all GS1 ID keys. They can hold 7,089 numbers or 4,296 alphanumeric characters.

DataBar family. There are seven members in the DataBar family. Generally, they’re divided into two groups: those designed for use at the point of sale (i.e., can be read by omnidirectional scanners) and those that are not.

The first group has four types: omnidirectional, stacked omnidirectional, expanded, and expanded stacked.

      • Omnidirectional and stacked omnidirectional have 14 numbers. They support GTINs and Global Coupon Numbers (GCNs) but do not support attributes.
      • Expanded and expanded stacked have a maximum capacity of 74 numeric and 41 alphabetic characters. They support GTINs and GCNs, but do support attributes.

There are three types of barcodes in the second group: truncated, limited, and stacked. These have 14 numbers and support GTINs, but do not support attributes. They are not designed for use at the point of sale, so they cannot be read by omnidirectional scanners.

1D barcodes. The two types of 1D barcodes — GS1-128 and ITF-14 — are used in retail distribution, healthcare, and logistics. GS1-128 barcodes can carry any GS1 ID key and up to 48 alphanumeric characters, including serial numbers, expiration dates, and other information that helps track products through a supply chain. More than one GS1-128 barcode can be used on a single item. ITF-14 barcodes can hold only GTINs; GS1 says it is suitable for printing on corrugated materials.

Final thoughts

This year was the 50th anniversary of the GTIN. As GS1 said, “It is no exaggeration to say that the development of the GTIN set the stage for global, digitalized commerce.” Indeed, labeling standards and barcode technologies have evolved and advanced since 1971 to the great benefit of businesses and consumers alike.

We have been talking about the advantages of end-to-end traceability in a digital supply chain for a long time. When your products, labeled with powerful identifiers such as 2D DataMatrix codes, move through a digital supply chain powered by our award-winning Traceability System, you can leverage rich, unit-level data for much more than compliance and operational efficiency: You can create genuine, tangible business value. For example:

That’s really just the beginning of what a digital supply chain can do. To learn more, contact us today to see a short demo of our solutions. Our supply chain experts will show you how our Traceability System transforms your supply into your most valuable strategic asset.

What is the Drug Supply Chain Security Act (DSCSA)?

Today’s question: What is the Drug Supply Chain Security Act (DSCSA)?

The Drug Supply Chain Security Act (DSCSA) was passed on November 27, 2013. Envisioning a 10-year journey leading to the complete serialization of the U.S. pharma supply chain and electronic, interoperable exchange of product information, the law is scheduled to take effect on November 27, 2023.

We’ve written extensively about the legislation, but with the deadline for full compliance quickly approaching, we thought an overview was in order.

So let’s take a look at the DSCSA from top to bottom — milestones, requirements, highlights, expectations, and challenges — and answer the question, What is the Drug Supply Chain Security Act?

The Most Recent DSCSA Developments

As the timeline below shows, the FDA has adjusted DSCSA compliance deadlines during the rollout. The most recent — and arguably most significant — happened in August 2023, when the Agency announced that it was delaying by one year enforcement of key DSCSA requirements. This “extended stabilization period” moves the enforcement date to November 27, 2024.

However, it’s vital that all supply chain actors understand that the original compliance deadline of November 27, 2023, still stands. The Agency has made it clear that the stabilization period is not a delay of the 2023 requirements: It expects companies to have implemented the mandated systems and work to ensure they are operating correctly, smoothly, etc.

In Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies, the FDA states:

This guidance is not intended to provide, and should not be viewed as providing, a justification for delaying efforts by trading partners to implement the enhanced drug distribution security requirements under section 582(g)(1) of the FD&C Act. FDA strongly urges trading partners to continue their efforts to implement necessary measures to satisfy these enhanced drug distribution security requirements.

So what’s the key takeaway: Don’t stop preparing for the DSCSA. If you have questions about the DSCSA stabilization period or are concerned that your current provider isn’t doing everything it can to set you up for success, we encourage you to contact us today to speak with one of our DSCSA experts. We are 100 percent committed to ensuring all of our customers meet DSCSA compliance.

DSCSA Timeline

A timeline showing key dates of the U.S. Drug Supply Chain Security Act (DSCSA) from 2013 to 2024

DSCSA at a Glance

Created as Title II of the Drug Quality and Security Act (DQSA), passed by Congress in November 2013, the DSCSA is an initiative to prevent the introduction and distribution of counterfeit, stolen, contaminated, or otherwise harmful drugs in the United States. It outlines steps to build an interoperable electronic system to identify and trace prescription drugs as they are distributed throughout the country. By providing comprehensive FDA guidance, the act facilitates the accurate tracing of products from the point of production to distribution to dispensation and beyond.

Understanding the Drug Supply Chain Security Act

If you’re a pharmaceutical company — a manufacturer, wholesaler, dispenser, repackager, or third-party logistics provider — you must comply with the Drug Supply Chain Security Act (DSCSA) if you want to do business in the United States.

The U.S. Food and Drug Administration (FDA) says the goal of the DSCSA is “to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.” The Act “will enhance [the] FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful” and “improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.”

As we said above, the law has been rolled out in phases since it was passed nearly 10 years ago. Even though enforcement was delayed until November 2024, the FDA expects all supply chain stakeholders to keep preparing.

Key Requirements of the Drug Supply Chain Security Act

The DSCSA requirements can be divided into several categories that apply to manufacturers, repackagers, wholesale distributors, dispensers, and 3PLs. Each is important, but four are particularly vital to being ready for November 2023 because they require these stakeholders to have specific systems in place to be fully compliant. These are the “four cornerstones” of DSCSA compliance:

Product identification (serialization)

Manufacturers and repackagers must put a unique product identifier (PI), such as a bar code, on certain prescription drug packages. This must be able to be read electronically.

Product tracing

Manufacturers, wholesale distributors, repackagers, and many dispensers (primarily pharmacies) must provide certain information about the drug and who handled it each time it’s sold:

      • Transaction information (TI) includes the product name; its strength and dosage form; its National Drug Code (NDC); container size and number of containers; lot number; transaction date; shipment date; and the name and address of the businesses from which and to which ownership is being transferred.
      • The transaction statement (TS) is a paper or electronic attestation by the business transferring ownership of the product that it has complied with the DSCSA.
      • A third type of information, Transaction history (TH), is an electronic statement with the TI for every transaction going back to the manufacturer. It is required before the November 27, 2023, deadline; it is not required after that date.

Verification

Manufacturers, wholesale distributors, repackagers, and dispensers must establish systems and processes to verify PIs for certain prescription drug packages. For saleable returns, manufacturers and wholesale distributors must use the Verification Router Service (VRS). Like everything else in the DSCSA, we’ve written extensively about the VRS. Our “DSCSA Saleable Returns Verification Requirement: Just the Facts” article is a good place to start.

Authorized trading partners (ATPs)

All manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers must be ATPs and be able to electronically verify that their trading partners are ATPs.

In broad terms, to be an ATP you must meet certain registration, licensing, and licensure reporting requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and comply with state licensing requirements. The definitions of ATP also include language about accepting or transferring direct ownership or possession of products.

There are “four cornerstones” of DSCSA compliance requirements:

Other DSCSA Requirements to Consider

Detection and response + notification: Stakeholders must quarantine and promptly investigate suspect or illegitimate drugs. They must also notify the FDA and other interested parties when they find such drugs.

Licensing: Wholesalers must report their licensing status and contact information to the FDA. Third-party logistics providers must obtain a state or federal license.

Final thoughts

What is the Drug Supply Chain Security Act? The DSCSA requires pharma stakeholders to work together to secure the U.S. supply chain. It doesn’t matter if you’re a manufacturer, wholesaler, repackager, third-party logistics provider, or a dispenser — the law affects how you conduct business. Your compliance depends on making sure you can meet your responsibilities.

That’s where rfxcel comes in.

We have 20 years of experience providing the pharmaceutical industry with leading regulatory and compliance software. So if you aren’t sure if you’re going to be ready for DSCSA 2023–2024 or you’re wondering if your current solution provider is doing everything it can to prepare you for compliance, contact us today.

Our DSCSA experts can show you a short demo of our solutions, clarify what your responsibilities are, and answer questions about your needs and how to meet them, no matter your role in the supply chain.

In the meantime, check out some of our other DSCSA resources, including our DSCSA: Preparing for the Full Serialization of the U.S. Pharmaceutical Supply Chain white paper and our DSCSA 2023 webinar series. These are great resources to help you better understand the law. You can click on those links or jump right to our DSCSA Compliance Library, a clearinghouse of all our information about the law.

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.