Understanding GS1 Barcodes in the Global Supply Chain

Posted on December 6, 2021August 4, 2023 by rfxadmin

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. 1. 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).

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. 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:

- - You can develop better brand protection strategies, including fighting the top supply chain threats (e.g., counterfeits and theft).
  - You can create next-level customer engagement programs and strategies.
  - You can improve recall management.
  - You can build your brand reputation and gain consumer trust.

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.

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

Posted on November 15, 2021October 9, 2023 by rfxadmin

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 supercharges 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.

How a Digital Consumer Goods Supply Chain Builds Brand Reputation & Trust

Posted on August 12, 2020August 21, 2020 by rfxadmin

Everybody knows people don’t shop like they used to. Today, consumers demand detailed information about the goods they purchase and expect to interact with products far beyond the point of sale. To make this happen, companies have to build a sharable product provenance and create a product experience. And they can do this with a digital consumer goods supply chain. Let’s see how.

What is a digital consumer goods supply chain?

First, let’s establish that when we talk about a digital consumer goods supply chain, we’re really talking about a digital supply chain for consumer goods.

What do we mean by this? Well, though a digital supply chain can most definitely be designed to serve the specific and unique needs of any industry — consumer goods, for example — in and of itself, it doesn’t discern or care about what industry it’s working for. It’s an important distinction, because any industry can (and should) have digital supply chain.

So, a digital consumer goods supply chain is exactly that: a digital supply chain for consumer goods. It has all the wonderful, powerful, customizable, data-centric capabilities of a digital supply chain “pointed at” the specific and unique needs of a consumer goods company. That can mean an apparel company, a company that makes fast-moving consumer goods, or a laundry detergent concern.

To break it down with industry lingo, a digital consumer goods supply chain will optimize operations for the four types of consumer goods: convenience products, shopping products, specialty products, and unsought products.

Using a digital supply chain to secure brand reputation and trust

Benjamin Franklin said, “It takes many good deeds to build a good reputation, and only one bad one to lose it.”

Franklin (probably) wasn’t thinking about the ability of a digital consumer goods supply chain to deliver end-to-end visibility and transparency, or its unique ability to engage people almost everywhere they go, before and after a sale. But if we could explain to Ben what all this means, he would (definitely) agree that a digital consumer goods supply chain was the key to securing brand reputation and trust.

Here’s how.

End-to-end visibility

End-to-end visibility in a digital consumer goods supply chain creates 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.

And let’s not forget the other benefits of end-to-end visibility. (In fact, all the things we’re talking about have additional benefits for consumer goods companies.) If you can see every part of your digital consumer goods 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.

End-to-end transparency

Transparency is a kind of “full disclosure” about what happens in your supply chain. For example, were the ingredients sourced in sustainable manner? Are all actors in your supply chain adhering to regulations and other pertinent laws?

And consumers want transparency. According to one recent study, a staggering 81 percent of food shoppers say transparency is important or extremely important to them — and if they don’t get it, they’re more than happy to buy another brand.

In a digital consumer goods supply chain, consumers can verify that you employ sustainable practices to make and deliver your products. They can get information that shows exactly where and how their shoes or clothing were manufactured. And if they can see that you’re doing everything “right,” your reputation will grow and they’ll trust you more (and maybe even tell their friends about you.)

Engage people almost everywhere they go

The customer is always right — but today that means more than merely ensuring they’re happy with your goods and services. Now it means you’re nurturing a committed relationship. Therefore, when we talk about engagement in a digital consumer goods supply chain, we’re talking about bringing the supply chain directly to consumers. Sharing details (not just visibility and transparency, by the way) and bringing people into the “world” of your brand.

The most effective way to do this is to use mobile traceability technology, which of course is all digital. It puts the supply chain right into the consumer’s hands. For example, using their mobile device, a person scans a 2D Data Matrix code on your product and is taken to a website full of relevant content, special offers, and so on. If you sell shoes, it may be a video of a famous athlete wearing your latest model. If you sell food items, it could be recipes or information about where the ingredients came from. It can be anything you want, really, from coupons to information about your sustainability and environmental efforts.

By taking advantage of mobile traceability, you’ll build your brand reputation and trust by presenting visibility and traceability information in a clear, compelling manner; enabling consumers to share a pre- and post-sale experience with your product; and fostering a lifelong relationship with your brand.

Final thoughts

If you don’t have a digital consumer goods supply chain, you aren’t maximizing your potential for building your brand reputation and consumer trust. Plus, you’re missing out on its many other benefits, including:

Monitoring and protecting your products 24/7
Mitigating risk and supply chain blind spots
Combatting counterfeits, fakes, and theft
Automating your workflow
Eliminating paper records
Future-proofing your operations

If you don’t have a digital supply chain, it’s all right. rfxcel was made for this moment. Our digital supply chain solutions, anchored by our award-winning rfxcel Traceability System, feature leading-edge products like our rfxcel Integrated Monitoring solution and MobileTraceability app for supply chain traceability and visibility. Our teams of experts can help you create a digital consumer goods supply chain that builds your brand reputation and consumer trust while delivering all the other benefits we’ve discussed above. Contact us today to find out more.

READY TO SEE WHAT RFXCEL CAN DO?

Saudi Pharma Compliance: New Aggregation Deadline & More

Posted on July 9, 2020July 24, 2020 by rfxadmin

Things have been relatively quiet with Saudi pharma compliance. The country’s Food and Drug Authority (SFDA) established the Drug Track and Trace System (RSD) to track all human registered drugs that are manufactured in Saudi Arabia or imported. Regulations that took effect in January 2019 have changed how the Saudi drug supply chain operates.

The RDS is a standardized identification system that tracks drugs from the manufacturer to the patient. It adopts GS1 standards and applies to all pharmaceutical products on the Saudi market, including over-the-counter (OTC) medicines. According to GS1, the SFDA is working on similar requirements for medical devices and cosmetics.

The SFDA’s goal is to create a safer and more efficient pharmaceutical supply chain. To succeed in the Saudi market, companies that produce, distribute, and dispense pharmaceuticals must fully understand and comply with the regulations. Let’s take a look at what’s been happening.

New Aggregation Deadline

Aggregation has been a sticking point in the Saudi pharma compliance requirements, with many delays for enactment. Here’s a quick timeline:

July 2019: The SFDA published guidelines for barcodes that included details for packaging hierarchies. This included barcoding, serialization, and pallet-level aggregation.
August 2019: The SFDA published a reminder about an upcoming October aggregation deadline.
December 2019: The SFDA moved the aggregation deadline to March 31, 2020.
April 2020: The SFDA moved the aggregation deadline to June 30, 2020.
June 28, 2020: The SFDA once again moved the aggregation deadline, this time till August 20, 2020.

So, as of today, companies have a little more than a month to comply with the aggregation requirements. This means they’ll have to prepare their packaging lines, coordinate with their trading partners, and have systems that can capture and report data to the RSD.

Overview of Saudi Pharma Compliance

Here’s quick rundown of what’s required for Saudi pharma compliance.

Data Matrix barcodes

Saudi regulations stipulate that all drugs must be marked with a GS1 Data Matrix barcode that contains, at minimum, a 14-digit Global Trade Identification Number (GTIN-14), a serial number, the expiry date, and the batch/lot number. This information must also be printed on labels. All transactions for drug packages must be reported to the RSD, and all manufacturers licensed by the SFDA must acquire a Global Location Number (GLN).

Saudi Drug Code

Every registered drug in the Saudi market is assigned a Saudi Drug Code (SDC) that contains four variables: a fixed prefix, the year, a letter to identify the type of drug, and a serial number (e.g., SFDA12D001). The SDC will eventually replace the current code.

Global Location Numbers

From March 2018, companies had to register the locations of their factories and warehouses using their Global Location Numbers (GLNs).

RSD Stakeholder Management and Operation Portals

Companies use the Stakeholder Management Portal for initial registration in the RSD. The Stakeholder Operation Portal is where companies and their stakeholders report movements of drugs inside the supply chain. This ensures that information about all shipments are reported to Saudi authorities.

According to the SFDA website, after a company has integrated its system with the RSD, all drug movements will be recorded automatically; companies/stakeholders won’t have to log in to the Stakeholder Operation Portal manually or register transactions manually.

Final thoughts

Saudi pharma compliance is complex. Manufacturers, warehouses, and pharmacies have a lot to think about. Though the date for implementing aggregation requirements has changed a few times, you should assume the August 20 deadline will hold firm.

The time to start preparing is now. rfxcel can help you be ready for all Saudi pharma compliance requirements. Our signature rfxcel Traceability Platform (rTS) can help you keep track of all the products in your supply chain and ensure you’re complying with all SFDA requirements — or regulations in any country.

Contact us for more information. Our supply chain experts are ready to help!

Supply Chain Visibility Can Fight Fraud in the Time of COVID-19

Posted on May 22, 2020July 24, 2020 by rfxadmin

Earlier this month, the U.S. Food and Drug Administration (FDA) posted an update about actions it’s taking to keep fraudulent COVID-19 treatments off the market. The examples of fraud the Agency gave illustrate why all industries — not just the pharmaceutical industry — need to embrace supply chain visibility. Let’s take a look at what the FDA said and why supply chain visibility is a panacea for the problem.

Consumer vulnerability, scammers, and unproven and potentially dangerous products

The FDA’s update addressed “the extremely concerning actions by companies and individuals that are exploiting or taking advantage of widespread fear among consumers during the COVID-19 pandemic.”

This statement reveals one reason fraud exists: consumer vulnerability. When people are confronted with a problem, especially one they feel they cannot control (such as a pandemic), some may tend to seek solutions without pausing to think them through. Peddlers of fake and substandard products are always ready to exploit this situation.

Which brings us to the scammers, many of whom use the internet to sell their bogus goods. Today, the FDA says, unscrupulous actors are claiming their products “mitigate, prevent, treat, diagnose, or cure COVID-19.” With the pandemic dominating headlines and weighing heavily on people’s minds, these quacks are only more than happy to offer unproven and potentially dangerous products.

What is the FDA doing, exactly?

The Agency has launched Operation Quack Hack to find and stop scammers. It’s located scores of phony products online, including fraudulent drugs, COVID-19 testing kits, and personal protective equipment. The FDA has issued 42 warning letters to companies making false COVID-19 claims and has sent hundreds of abuse complaints to domain name registrars and internet marketplaces, most of which have voluntarily removed the offending product pages.

One of the warning letters went to an organization selling fraudulent chlorine dioxide products as a COVID-19 treatment. When it refused to cease and desist sales of its so-called Miracle Mineral Solution, or “MMS,” a federal court issued a preliminary injunction requiring it to immediately stop distributing the product. The FDA characterizes chlorine dioxide as the equivalent of industrial bleach and since 2010 has been warning consumers about MMS and other products with names such as Master Mineral Solution, Chlorine Dioxide Protocol, and Water Purification Solution (WPS).

The FDA also intercepted and investigated a case of mislabeled COVID-19 “treatment kits” that someone was trying to import into the United States. Also, an FDA investigation led to a U.S. Department of Justice criminal complaint against a British man “who sought to profit from [the] pandemic and jeopardize public health.”

How supply chain visibility can fight fraud

Visibility means using data to gain insight into how a supply chain is functioning and to take steps to make it run more efficiently. The goal is to see everything.

A company must have systems that can gather and report data from one end of the supply chain to the other. Data should be as “rich” as possible; today, that means a digital supply chain with real-time access to unit-level data about everything from ingredients to temperature.

Here’s a rundown of how supply chain visibility can fight fraud. We’re using the pharma industry in our example, but the tenets apply to any product in any industry.

- You know the origin of your ingredients. Supply chain visibility allows a manufacturer to verify that all the ingredients of a drug are legitimate. It can track every ingredient up until the time they’re combined to make the drug.

- You can follow the drug’s every move: Part 1. After the drug has been manufactured, bottled, and packed into cases, you can see everywhere those cases go after they leave the plant — warehouses, stores, pharmacies, hospitals, etc. — and you can track their movements in real time. With supply chain visibility, you can anticipate traffic bottlenecks and reroute the delivery vehicle, keeping the shipment on time. You’ll also know if the delivery vehicle has been diverted from its prescribed route, which could indicate theft.

- You know if the drug has been harmed or compromised. Supply chain visibility means you’ll be alerted if there’s a problem with the shipment. For example, if there’s been a change in temperature, light, or humidity that can affect the drug’s efficacy, or if the cases have been dropped or jolted in a way that might have damaged the bottles, packets, or vials inside. And we’ve already mentioned route diversion and theft.

- You can follow the drug’s every move: Part 2. When the cases are separated (e.g., taken off a pallet), you can follow each one; when a case is opened, supply chain visibility lets you follow the individual bottles or packets all the way to check-out at the cash register or stocking at a pharmacy or hospital.

Final thoughts

Supply chain visibility creates an “airtight” supply chain that leaves virtually no room for unproven, potentially dangerous, fake, or otherwise fraudulent products to sneak in. And if such a product does appear, supply chain visibility means you can remove it faster. After all, when you can see everything, it’s easier to spot imposters and get rid of them.

rfxcel can provide supply chain visibility in any industry. Our signature rfxcel Traceability System (rTS) is a full-stack visibility and track and trace platform that comprises solutions that empower end-to-end supply chain visibility, including:

- rfxcel Serialization Processing (rSP) assigns and manages unique identifiers for products to unleash detailed tracking down to the unit level.

- rfxcel Compliance Management (rCM) allows rapid adherence to government and industry reporting requirements of your goods as they move through the supply chain.

- rfxcel Integrated Monitoring (rIM) is an award-winning solution that uses Internet of Things (IoT)-enabled devices to provide real-time data about 12+ environmental conditions (e.g., location, temperature, shock) of products anywhere in the world.

- rfxcel MobileTraceability brings the power of an rTS digital supply chain to your smartphone, tablet, or other mobile device.

As FDA Associate Commissioner for Regulatory Affairs Dr. Judy McMeekin said, “It is imperative that we continue our efforts to find and prevent the sale and distribution of products that may be harmful to the public health.” Supply chain visibility is the way to do this. Contact us today to find out how we can help you.

rfxcel CEO Glenn Abood Talks Supply Chain Visibility, Improving Supply Chain Efficiency

Posted on May 1, 2020July 27, 2020 by rfxadmin

rfxcel Co-Founder and CEO Glenn Abood spoke yesterday with Channel 2 News at our headquarters in Reno, Nevada. He fielded questions about supply chain visibility, improving supply chain efficiency, and our rfxcel Integrated Monitoring (rIM) solution. Glenn last spoke with Channel 2 in November 2018, right after we announced that we were moving our headquarters to Reno.

Here’s a recap of yesterday’s conversation.

The power of rIM for supply chain visibility

Glenn explained how rIM improves supply chain visibility by tracking raw materials and finished products in real time as they are transported to their final destinations. rIM helps avoid counterfeits and out-of-stocks, and helps ensure that items get where they need to be, safely and on time.

State of the supply chain

Glenn said the transportation industry was doing a good job of keeping up with demand. There are, however, some problems. “There are certain parts of the supply chain that aren’t functioning as well as they should,” he said. There are also outages along the supply chain.

The key is supply chain visibility. With rIM and other rfxcel solutions, companies can know where everything in their supply chain came from, where it is right now, where it is going and when it gets there. For example, they can find out if an ingredient or raw material sourced from abroad is being delayed due things such as shortages and bottlenecks — whether related to COVID-19 or not.

The benefits of supply chain visibility

Glenn said supply chain visibility benefits everyone, from industry stakeholders all the way to consumers. Manufacturers are empowered to manage inventory issues more effectively. Counterfeit products are targeted and eliminated from the supply chain, resulting in greater consumer confidence.

Final thoughts

It would be impossible to explain rIM and our other supply chain visibility solutions in a 2-minute interview on the evening news. But Glenn did a great job summarizing what we do. It’s all about supply chain visibility. Contact us today to learn more about our solutions and how they can optimize your supply chain, no matter what industry you’re in.

And be sure to check out Glenn’s interview!

Exploring the Latest Updates to China Pharma Regulations: Reporting, Coding & Printing

Posted on March 10, 2020July 11, 2023 by rfxadmin

China’s pharma regulations can be confusing. However, the Chinese National Medical Products Administration (NMPA) published a set of documents last year that clarified the country’s new serialization code. Released on April 28, 2019, the documents cover regulations for pharma ranging from coding requirements to guidelines for event reporting.

These documents are a valuable resource to help understand China’s complicated regulations. For example, they state that manufacturing authorization holders must build a traceability system, which they can create themselves or through a third party. In order to trade at an item level, issuing agencies must create a serial number generation strategy to ensure one-of-a-kind traceability codes.

Let’s discuss a few critical points of the regulatory requirements for pharma in China.

Chinese Pharma Reporting

Previous Chinese pharma regulations had strict reporting guidelines. Under the new regulations, pharma companies are not required to request or receive serial numbers from a central or state-controlled source as long as the number schemes are compliant with set standards. This allows manufacturers more control over which software solutions they can use.

Companies must also exchange all the information they generate and report with their supply chain partners — who, in turn, must also report their own data to the government.

Chinese Pharmaceutical Coding Requirements

The NMPA advises that China’s drug traceability strategy should incorporate current and future manufacturing and production needs. For coding, China requires a drug traceability code, a drug identification code, and a product identification code.

The drug traceability code will identify a sales package at the unit level. The code is a combination of numbers, letters, and symbols. To be compliant, the code must include 20 characters (seven of these are the drug identification code) and adhere to ISO standards.

The drug identification code identifies the license holder, generic drug name, manufacturer, formulation, dosage form, specifications, and package specifications. The product identification code contains manufacturing data.

Chinese Printing Requirements

All printed information must be readable by the human eye. But China’s regulatory requirements do establish some guidelines for machine-readable data. Companies can choose from a 2D matrix/RFID tag or a linear bar code. This data must include:

Batch and serial number
Production date
Pharmaceutical form
Information about the manufacturing authorization holder
Expiry date

Our Global Pharma Compliance Software Solutions

rfxcel has been developing innovative supply chain solutions and helping pharma companies with serialization, compliance, and traceability since 2003. We’re experts in global compliance and are here to answer your questions about regulations in any country, including China. To learn more about how you can stay compliant, no matter where you do business, contact us today!

Understanding Pharmaceutical Serialization Track and Trace: Enhancing Visibility and Safety

Posted on September 6, 2017July 11, 2023 by rfxadmin

Serialization is the process of assigning predetermined codes to each unit or container of medication you manufacture. The code or serial number assigns each product item a digital identity, which you can track and trace as it progresses throughout the supply chain. Pharmaceutical serialization is a common type which is used to track and trace and provide supply chain visibility for pharmaceutical drugs.

When designing a codification system, you can make your serialization codes as detailed as government regulations necessitate.

Additionally, you can incorporate information like the date of production, when and where the item was manufactured, a lot or batch number, the stock-keeping unit (SKU), a drug or product description, and the manufacturer’s Global Trade Identification Number (GTIN).

Leading solutions also provide built-in code structure flexibility that can accommodate customized application identifiers (AIs). GS1, the internationally-recognized system of standards, created a dynamic definition of AIs that gives you the freedom to include a wealth of information in your code.

Now that we’ve addressed the question, “What is serialization,” let’s examine why it’s important to the pharmaceutical industry and how you can tap into significant organizational benefits by adopting modern serialization software.

What Is Pharmaceutical Serialization?

To adequately define serialization, we must not only consider the meaning of the term but also discuss why serializing products is a critical business management process.

Over the last several years, regulatory entities such as the European Medicine Agency (EMA) and the U.S. Food and Drug Administration (USFDA) have implemented significant changes to pharmaceutical regulations.

Why Is Serialization Important in the Pharmaceutical Industry?

The FDA’s Drug Supply Chain Security Act (DSCSA) is the most notable of these changes. While the DSCSA was passed in 2013, its final phase of provisions will come into force in late 2023. Among other things, this act requires that pharmaceutical products be serialized to promote traceability and preserve product integrity.

Serialization techniques may vary slightly from one nation to another. However, all labels will include some basic product information, regardless of the country of origin.

For instance, a product label will typically include the following:

A unique serial number
A batch number
An expiration date
An identification code

Performing pharmaceutical serialization reduces the risks of harm associated with counterfeit medicines seeping into the market. Additionally, serializing medications allows regulatory authorities to hold violators accountable, preserve the integrity of the pharmacological supply chain, and protect consumers.

From your organization’s perspective, pharmaceutical serialization plays an important role in compliance. The aforementioned laws impose harsh penalties on entities that fail to comply with labeling and serialization requirements.

Looking Beyond Compliance: The Benefits of Pharmaceutical Serialization

Now that we’ve answered the question, “What does serialization mean” and touched on the growing importance of this tracking and identification method, let’s shift our attention to the benefits of implementing a serialization strategy.

Pharmaceutical serialization is an effective way of ensuring adherence to regulatory requirements and safety guidelines. Countless entities within the pharmaceutical space use serialization software for data validation and compliance purposes.

That said, compliance is just one benefit of pharmaceutical serialization. It can also assist with the following:

Supply Chain Visibility

The pharmacological supply and distribution network is one of the most complex in existence. Historically, this complexity has made achieving end-to-end supply chain visibility difficult.

While pharmaceutical serialization won’t entirely solve the industry’s visibility problem, it will certainly have a big impact on overall supply chain transparency. By equipping products with unique identifiers, manufacturers can track materials, ingredients, and finished products as they progress through the supply chain.

Serialization enables manufacturers to closely manage their logistics processes. They can use these insights to pinpoint potential bottlenecks, increase supply chain efficiency, and ensure the timely delivery of goods to consumers.

Combating Counterfeiting

According to the Centers for Disease Control (CDC), approximately 9%–41% of medicinal products sold in low-to-mid-income nations are counterfeit.

Comparatively, less than 1% of pharmaceutical products sold in the U.S. are counterfeit. The FDA’s stringent labeling and serialization requirements are a major reason why counterfeit medicines aren’t a major issue in the U.S.

Expanding pharmaceutical serialization standards can help combat counterfeiting in less-developed low-income countries. Putting a stop to the distribution and sale of fraudulent products will also enable manufacturers to preserve their reputations in international markets.

Serialization gives retailers, distributors, and end users a means of discerning whether products are part of a legitimate batch of medication. Scannable codes are a particularly convenient and useful authentication tool, as they’re difficult for counterfeiters to fake.

Coordinating Product Recalls

Despite a manufacturer’s best efforts, medical devices and drugs sometimes must be recalled and taken out of circulation. Without an effective pharmaceutical serialization strategy in place, manufacturers must cast a wide net. This leads to significant waste, as safe, effective products are recalled and disposed of.

Properly executed pharmaceutical serialization helps manufacturers determine precisely which batches were impacted so they can reduce waste and limit the scope of recalls. Serialization and labeling also enable manufacturers to coordinate with government agencies to maximize the efficiency of recall efforts.

Monitoring Consumption Rates

Through serialization and labeling, manufacturers can track products from the factory to the point of consumption. They can leverage these insights to monitor each batch, examine consumption volume, and keep up with demand.

As demand wanes, manufacturers can adjust accordingly to preserve liquidity and avoid over-ordering raw materials. If consumer demand spikes suddenly, the manufacturer can scale production back up to prevent shortages and ensure that patients have access to essential medications.

Challenges to Serialization

As you can see, pharmaceutical serialization is a critical component of compliance. This process also has an impact on client satisfaction, patient safety, and your organization’s profitability.

Efficient serialization processes will enable you to adapt effectively to fluctuating consumer demand, protect your brand image, and optimize supply chain visibility. However, before you can unlock the benefits of pharmaceutical serialization, you must first overcome several challenges, including the following.

Aggregation

Data aggregation is key to promoting traceability and supporting the steady flow of goods across the pharmaceutical supply chain. Aggregation is the process of consolidating information from each participant in your supply chain into a unified, secure, and accessible database.

Let’s say your organization is the third link in the supply chain. The first is the raw material supplier, and the second is the carrier that delivers those materials to your facility.

When you receive the materials, you must assimilate the information from the supplier and carrier into your database. You also need to supplement this information with your own data.

Deadlines

Facing a rapidly approaching deadline can lead to a mad dash to modernize your pharmaceutical serialization protocols. Feeling the pressure of these deadlines will speed up your adoption process, right? Yes and no.

While you may be able to quickly adopt some new technology, waiting until the last minute can cause you to overlook essential steps during implementation. As a result, you’ll have to backtrack to fix gaps in your serialization strategy.

If you haven’t already begun implementing pharmaceutical serialization technology and processes, now is the time to start.

Repacking

Aggregating data will help you track and serialize whole boxes and pallets of products. But what happens if a customer needs a partial pallet or box? While you could raise your minimum order quantities (MOQ) to prevent this, doing so can deter purchases and negatively impact your sales volume.

When designing your serialization process, include an integrated repack phase so you can offer partial orders. When a picker scans the item serial numbers, the solution will repack the numbers and assign product data to the appropriate pallet or box.

Infrastructure

While you may already have serialization software, that platform likely lacks the scalability and flexibility of more modern solutions. As a result, you may not have the technological infrastructure necessary to support efficient pharmaceutical serialization.

The good news is the solution to this hurdle is relatively simple: replace your aging legacy technology with the world’s most scalable and robust serialization software from rfxcel.

Our leading-edge, flexible serialization solution can help you meet today’s labeling requirements and prepare for the unexpected regulatory challenges of tomorrow. Rfxcel not only provides you with dynamic software but also assists with the implementation process so you can maximize your ROI while minimizing the procedural hassle.

Expedite Your Serialization Implementation Process with rfxcel

With the final phase of the DSCSA rollout rapidly approaching, your organization must ensure that it has the right serialization software to support its compliance. Otherwise, you’ll find yourself struggling to meet the stringent requirements of the FDA’s latest drug safety and traceability provisions.

Serialization isn’t just crucial for pharmaceutical compliance. It also influences patient safety. By engaging in serialization, you can prevent bad actors from perpetrating your supply line and releasing illegitimate medications under your brand name.

Fraudulent activities endanger consumers and threaten your organization’s reputation. Fortunately, you can protect consumers, preserve your brand image, and ensure compliance with the DSCSA by partnering with a forward-thinking serialization software provider like rfxcel.

We offer a variety of labeling, tracing, and serialization solutions designed to meet the unique needs of the pharmaceutical sector.

Contact rfxcel today to learn more about our suite of solutions.