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?

India Pharma News: FDA Recalls, COVID-19 Vaccine & Ideas Summit 2020

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

The last time we checked in on the India pharma supply chain, the country had announced restrictions on the export of active pharmaceutical ingredients and medicines, launched its national iVEDA portal for drug authentication and track and trace, and changed a deadline for regulations concerning drug exports.

There have been some India pharma headlines in the last week or two, so let’s do a summer roundup.

FDA Recall of India Pharma Products

The U.S. Food and Drug Administration (FDA) and the Indian government work together on pharma supply chain issues. From January 28–30, 2020, for example, a joint action called Operation Broadsword prevented approximately 500 shipments of illegal and unapproved prescription drugs and medical devices from reaching U.S. consumers.

Now, two Indian pharma companies are voluntarily recalling lots of Metformin Hydrochloride Extended-Release Tablets because FDA analysis revealed they could contain nitrosodimethylamine (NDMA), a known carcinogen, above the acceptable limit. The recall affects both 500mg and 1000mg tablets. Metformin is commonly used to treat type 2 diabetes. A complete list of all metformin products being recalled is available on the FDA website.

There are two other FDA recalls affecting Indian pharma companies. About 1,500 bottles of Clozapine are being recalled after 50mg tablets were found in bottles of 100mg tablets, and one lot of Aripiprazole tablets are being recalled because bottles labeled as containing 30 2mg tablets actually contain 100 5mg tablets. Clozapine is used to treat mood/mental disorders and Aripiprazole is used to treat schizophrenia and bipolar disorder.

India pharma company anticipates COVID-19 vaccine early next year

The chairman of Ahmedabad-based Zydus Cadila says he expects phase 1 and phase 2 studies of its novel coronavirus vaccine to be completed in three months. It is currently testing the vaccine, ZyCoV-D, for safety and efficacy. It will be compared with placebo.

As reported in the Hindu Times, Chairman Pankaj Patel said the vaccine could be ready in “about seven or a little more than seven months … provided the data is encouraging and the vaccine is proven to be effective during the trials.” He said Cadila might be able to produce up to 100 million doses a year.

Zydus Cadila is also planning to produce remdesivir, which is being used worldwide to treat COVID-19. Patel the company could produce up to 400,000 doses of the medicine in the first month after it wins regulatory approval to manufacture it in India.

India Ideas Summit 2020

The United States India Business Council (USIBC) is holding its 45th annual meeting next week. Together with the U.S. Chamber of Commerce, it will host the Ideas Summit, also an annual event, from July 21-22. It will be a virtual gathering, naturally.

This year’s theme is “Building a Better Future.” Looking to a “post-COVID world,” diplomats, scholars, senior business executives, think tanks, and other thought leaders will discuss topics ranging from geopolitics and equitable growth to the future of healthcare and digitization and technology trends.

They will also focus on global supply chains. This month, the USIBC released a white paper entitled “Positioning India to Capture Global Supply Chains & Grow Economic Opportunity.” The 22-page paper is of interest to anyone who follows supply chains and recognizes India’s position in global markets. It touches on the work of the USIBC Task Force on Supply Chain Standards and Practices and how the country is working to attract new supply chains. Read the white paper here.

Final thoughts

India will undoubtedly continue to cultivate its position in the global pharmaceutical industry. It’s actively modernizing its supply chain. For example, in April it replaced its Drugs Authentication and Verification Application (DAVA) with the Integrated Validation of Exports of Drugs from India and its Authentication (iVEDA) portal.

We’ve worked in the India pharma market for many years and understand its complexities, challenges, and benefits. Our signature rfxcel Traceability System (rTS) and rfxcel Compliance Management (rCM) solution have helped our customers keep up with India’s regulations and remain competitive.

Contact us today to see how we can maximize your impact in India.

rfxcel Continues Winning Streak in Russian Serialization, Track and Trace

Posted on July 15, 2020October 28, 2022 by rfxadmin

Once again, Russia’s Center for Research in Perspective Technologies (CRPT) has named rfxcel an official partner, this time for software and integration for dairy, bottled water, footwear, wheelchairs, tires, perfumes, bicycles, and light industry. We’re pretty excited about this. We had already been named an official software, integration, and tested solutions partner for medications. Our team in Moscow has worked hard to make us the leader in Russian serialization and track and trace for all industries; you should contact them if you have any questions about doing business in Russia.

The CRPT is a public-private partnership that manages Russia’s National Track and Trace Digital System, known as Chestny ZNAK. Our rfxcel Traceability System (rTS) works seamlessly with the system, including a Russian-language user interface that makes integration and startup much quicker.

Let’s take a quick look at what’s going on with the dairy and bottled water industries in Russia, and why we’re leading in Russian serialization and track and trace.

The CRPT and Russian Serialization/ChestnyZNAK “Experiments”

The CRPT follows best practices by conducting “experiments” — what we would call pilots — for products before the officially enter the ChestnyZNAK system. The pilot for dairy ran from July 15, 2019, to February 29, 2020; for bottled water, the pilot began April 1, 2030, and is scheduled to end March 1, 2021.

A pilot for bicycles wrapped at the end of May 2020, and a current one for wheelchairs is expected to end June 1, 2021. Pilots for children’s goods (e.g., baby food, clothing, toys, and games) and medical devices will apparently be announced soon.

Requirements for Dairy and Bottled Water

Russia’s supply chain regulations are notoriously strict. This is one reason being named an official CRPT partner is a feather in our cap: We’ve demonstrated that our solutions, particularly our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the requirements and ensure companies stay compliant.

We’re currently working on some other materials about the regulations for dairy and bottled water (and tires and other products), so check back soon to see those. In the meantime, however, here’s some basic information to tide you over.

Dairy

All products must be labeled with a DataMatrix code. The code must contain the following:

The goods code (14 numerical digits)
An individual serial number (13 digits) generated by the CRPT or a company’s economic agent
A verification key provided by the CRPT (4 digits)

According to the language in the regulations, companies may include an expiration date (6 characters for non-perishables, 10 for perishables), but that is not mandatory.

Product packaging mush have a 15×15 mm space for the codes. If a product has a cap, such milk in a PET bottle, the material and surface texture must be able to accommodate printing (e.g., ink or laser).

Bottled water

The regulations recognize six categories of bottled water. In addition to three unexplained “other” categories, these include:

Waters, including natural or artificial mineral, carbonated, free from sugar or other sweetening or flavoring substances. (The regulations also mention “ice and snow” under this category.)
Mineral and carbonated waters, including natural mineral waters:
Non-carbonated waters

The DataMatrix code must contain the same information as the codes for dairy. And like dairy, companies have the option to include other information, such as an expiration date or a minimum retail price.

Final thoughts

Our success with the CRPT is due to a lot of hard work and our commitment to designing the best solutions for Russian serialization, track and trace, aggregation, and compliance.

When Chestny ZNAK was enacted into law on December 29, 2017, we began honing our operations in Russia. About this time last year, we reported that we had doubled the size of our team in Russia; since then, it’s tripled in size. We’re one of very few supply chain solution providers with active implementations in Russia, and we’re working with more and more companies as our reputation grows.

Our continued success with the CRPT, ChestnyZNAK, and Russian serialization boils down to the quality of our solutions and the knowledge and skill of our people, who have expertise in key areas of supply chain management and technology. They all speak Russian, of course, and they know the regulations inside and out. They understand how to meet our customers’ needs while ensuring they’re fully compliant with Russian serialization, aggregation, and supply chain compliance requirements.

Contact us today learn more about how rfxcel can help you with Russian serialization and the ChestnyZNAK regulations. And be sure to ask about our other track and trace and compliance solutions. Sure, we’re the leader in Russian serialization, aggregation, track and trace, and supply chain compliance solutions, but we can optimize any supply chain anywhere in the world. Ask us how!

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.

FDA DSCSA Guidance Update: Transaction and Distribution Activities During COVID-19 Emergency

Posted on May 1, 2020July 24, 2020 by rfxadmin

On April 30, the U.S. Food and Drug Administration (FDA) issued guidance for “flexibility” pertaining to certain transaction and wholesale distribution activities under the Drug Supply Chain Security Act (DSCSA). This was a direct response to the COVID-19 public health emergency. Here’s what the FDA DSCSA guidance says.

Legal Basis for the FDA DSCSA Guidance

Public health emergencies in the United States are provided for under Section 319 of the Public Health Service Act (PHS Act). When an emergency is declared, two statutory provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act) are automatically triggered:

1. The exemption of certain product distribution activities from the definition of transaction under the FD&C Act section 581(24)
2. The exclusion of certain product distribution activities from the definition of wholesale distribution under the FD&C Act section 503(e)(4)

What the FDA DSCSA Guidance Says

The transaction exemption and wholesale distribution exclusion provisions mean that two DSCSA requirements do not apply to some distribution activities during the COVID-19 public health emergency:

1. Distribution of “covered COVID-19 products” to address the public health emergency. The transaction exemption and wholesale distribution exclusion apply to the following:

- The distribution of prescription drug products that have been issued an Emergency Use Authorization (EAU) by the FDA. To date, this includes hydroxychloroquine sulfate, chloroquine phosphate, and, as of today, May 1, remdesivir. An EAU designation does not mean the FDA has approved a drug for a specific use; to date, the FDA has not approved any product to treat COVID-19.
- FDA-approved products to diagnose, cure, mitigate, treat, or prevent COVID-19. According to the FDA website, this includes in vitro diagnostic products; high complexity molecular-based laboratory developed tests; personal protective equipment and related devices; ventilators and other medical devices; and therapeutics.

The FDA says that companies involved in the distribution of covered COVID-19 products should “maintain the security of the supply chain as these products are distributed to address the urgent public health need.” If possible, companies should continue to fully comply with the DSCSA regulations if doing so isn’t “a barrier to timely distribution of covered COVID-19 products.”

2. Distribution of other products affected by the COVID-19 public health emergency. The transaction exemption and wholesale distribution exclusion also extend to the distribution of “other affected products in certain circumstances.” For COVID-19, these circumstances exist when:

- The distribution activities are directly affected by the COVID-19 public health emergency.
- The distribution activities are for emergency medical reasons, such as treating symptoms of COVID-19.

The FDA gives three examples of when the COVID-19 public health emergency could directly affect distribution of these other products:

- Distribution to an area where product availability is limited and there is higher demand.
- Distribution by an authorized trading partner that needs to establish a new, temporary facility for distribution.
- Dispenser-to-dispenser transfers of products that are needed, regardless of whether there is a specific patient need.

3. There are a few other parameters for the FDA DSCSA Guidance:

- They apply only to products distributed to address the COVID-19 public health emergency.
- They apply to products that were already in the supply chain when the COVID-19 public health emergency was first declared.
- They do not apply to a drug shortage unless it is caused by the public health emergency.
- They are in effect only as long as the COVID-19 public health emergency is in effect.

Final thoughts

For the record, the U.S. COVID-19 public health emergency first went into effect on January 27, 2020. A 90-day renewal took effect on April 26. And as we all know, it’s had a huge impact on people’s lives and the global economy.

rfxcel is committed to being part of the solution. We recently released our Accurate Immunization Management Solution (AIM), an automated, cloud-based solution that tracks the dispensing of vaccines in the supply chain — including potential COVID-19 vaccines. We’ve joined the COVID-19 Healthcare Coalition. We are open and operating at full capacity. Contact us today if you have any questions about our supply chain visibility solutions or our work during the COVID-19 public health emergency.

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!

rfxcel Joins the COVID-19 Healthcare Coalition

Posted on April 7, 2020December 2, 2020 by rfxadmin

Washington, D.C., April 6, 2020. rfxcel, the global leader in digital supply chain traceability solutions, today announced that it has joined the COVID-19 Healthcare Coalition, a collaborative private-industry response to novel coronavirus that brings together leading organizations in healthcare, technology, academia, the nonprofit sector, and government.

The coalition’s goal is to save lives through data analytics. Gathering real-time data is key to learning about COVID-19 and how to best deliver healthcare to protect public health.

The coalition operates according to five guiding principles:

- All members participate for the benefit of the country only. No organization will be given preferential advantage.
- All members cooperate and openly share their plans.
- Members will not be paid for working with the coalition. Each member brings its own resources; no money is exchanged.
- Verbal agreements will suffice to get the coalition’s work started.
- If an organization agrees to these terms and conditions, it can join the coalition.

rfxcel has been developing industry-leading track and trace software since 2003, longer than any company serving the life sciences and the business of government. Keeping with the coalition’s wish for members to bring their unique assets to support industry stakeholders, front-line responders, and federal, state, and local government organizations in the COVID-19 pandemic, the company is offering two of its cutting-edge supply chain solutions, rfxcel Integrated Monitoring (rIM) and Accurate Immunization Management (AIM), as part of its contribution to the COVID-19 Healthcare Coalition.

rfxcel Integrated Monitoring (rIM)

rIM uses Internet of Things (IoT) technology to monitor the environmental condition of products in real time as they move through supply chains on land, sea, and air. It is widely used in pharmaceutical cold chains to monitor high-value medical supplies, including vaccines. rIM communicates with small IoT-enabled devices embedded with products and sends updates and alerts about more than a dozen environmental conditions, such as temperature, humidity, light, orientation (tilt), and shock. It also monitors location, so it can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements. It can monitor at both the top level (e.g., case, pallet, truck) and the item level (e.g., syringe, packet, bottle), yielding true supply chain traceability and transparency.

Accurate Immunization Management (AIM)

AIM is an automated, cloud-based solution that tracks the dispensing of vaccines — including potential vaccines for COVID-19 — in the supply chain and seamlessly integrates with critical healthcare applications such as Electronic Health Records (EHRs) and Immunization Information Systems (IIS). It empowers healthcare practitioners to view patients’ immunization records in real time, manage accurate administering, monitor inventory, and safely dispense the right vaccines to the right patient at the right time. AIM utilizes Centers for Disease Control and Prevention (CDC) rules and guidance for vaccine combinations, special populations, and required intervals between vaccines, and adheres to U.S. Food and Drug Administration (FDA) rules for dispensing. Because it is automated, users can be up and running with virtually no training, ensuring quick implementation in mission-critical locations.

Greg Moulthrop, vice president of rfxcel’s Worldwide Government Group, and his Washington, D.C.-based team of government and supply chain experts are leading the company’s efforts to bring rIM and AIM to the coalition’s fight against COVID-19. rfxcel will support the Supply Chain Working Group, facilitated by MITRE Corporation, to bring its technology to coalition members. Working across government and in partnership with industry, MITRE and its public-private partnerships and federally funded R&D centers tackle challenges to the safety, stability, and well-being of the country.

“We are proud to be a member of the COVID-19 Healthcare Coalition and donate our time and resources to addressing this public health crisis,” Moulthrop said. “rfxcel’s Worldwide Government Group is focused on mission readiness and develops tools to protect the supply chain against disruptions for the most vulnerable products. We care about protecting the public; in this case, we must protect the health and well-being of people across the country — across the world — against COVID-19, which is revealing how much we rely on robust, secure supply chains. With rIM and AIM, rfxcel can do its part to safeguard people and, we hope, hasten both the end of COVID-19 and the recovery of our communities and economy.”

rfxcel CEO Glenn Abood said the company was honored to join the coalition and was eager to get to work. “We had been considering how we could do more to help defeat COVID-19,” he said. “We feel that our everyday work is helping by keeping supply chains moving in the pharma, food and beverage, and consumer goods industries, but we felt we could do more. When Greg told us about the coalition, we were all in.

“rIM is an award-winning environmental monitoring solution that’s proved itself over and over in the pharma industry,” Abood continued, “so it was a logical choice to share with the coalition. And AIM, which we released late last month, was a no-brainer. We had been working on it for a while and successfully tested it with some of our major customers. We were excited about releasing it, but we couldn’t have imagined the timing would coincide with COVID-19. We hope deploying it to the coalition will make a difference.”

To learn more about rfxcel’s work with the COVID-19 Healthcare Coalition or what rfxcel offers the government, contact Greg Moulthrop, vice president of rfxcel’s Worldwide Government Group, at publicservices@rfxcel.com or visit rfxgov.com.

To learn more about rfxcel and its supply chain solutions, contact Vice President of Marketing Herb Wong at 925-824-0300 or hwong@rfxcel.com and visit rfxcel.com.

About rfxcel

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

FDA Asks for All Ranitidine Products (Zantac) to Be Removed from the Market

Posted on April 7, 2020July 24, 2020 by rfxadmin

On April 1, the U.S. Food and Drug Administration (FDA) requested that manufacturers immediately withdraw from the market all prescription and over-the-counter (OTC) ranitidine drugs, commonly known by the brand name Zantac. As a result, ranitidine products will not be available for new or existing prescriptions or OTC use in the United States.

Ranitidine is widely used to treat and prevent heartburn. It can also treat gastroesophageal reflux disease (GERD), stomach ulcers, and conditions that cause too much stomach acid. As a generic drug, it’s sold primarily to decrease production of stomach acid.

As early as September 19, 2019, the FDA alerted patients and healthcare professionals that a contaminant known as N-Nitrosodimethylamine (NDMA), suspected to be a human carcinogen, had been found in samples of ranitidine. Since then, the agency has released more than 15 announcements about its investigation into the contamination, several of which called for limited voluntary recalls and culminated in the April 1 request that all ranitidine be removed from the market.

What the FDA testing revealed about Zantac/ranitidine

According to the FDA, the NDMA levels in some ranitidine products increases over time. Furthermore, when the products are stored at higher-than-room temperatures, it could “result in consumer exposure to unacceptable levels of the impurity.” Although the agency didn’t find unacceptable levels of NDMA in many of the samples that were tested, it decided to issue the request because it couldn’t verify under what conditions medications had been stored.

The FDA’s initial tests found low levels of NDMA in ranitidine. Low levels of NDMA can be found in foods and in water but are not expected to increase the risk of cancer; however, sustained higher levels of exposure may increase the risk. More recent testing confirmed the following:

- NDMA levels increase in ranitidine even under normal storage conditions.
- NDMA has been found to increase significantly in samples stored at higher temperatures, including temperatures products may be exposed to during distribution and handling by consumers.
- The older a ranitidine product is, the greater the level of NDMA.
- These conditions may increase the level of NDMA in ranitidine products above the acceptable daily intake limit.

What consumers should do if they’re taking Zantac/ranitidine and/or have it in their home

In addition requesting that manufacturers withdraw ranitidine products from the market, the FDA advises that consumers stop taking any OTC ranitidine tablets or liquid they have at home, dispose of them properly, and not buy more. People who want to continue treating their condition should use other approved OTC products. Patients taking prescription ranitidine should consult their doctors about other options before stopping the medicine.

There are several drugs approved for the same or similar uses as Zantac/ranitidine that do not have the same NDMA risk. To date, FDA testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).

Because of the COVID-19 pandemic, the FDA asks that patients and consumers do not take their medicines to a drug take-back location; instead, they should follow disposal instructions included with their medication or follow the agency’s guidance for safe home disposal.

rfxcel’s Integrated Monitoring (rIM) solution monitors temperature and other environmental factors, safeguarding products in the supply chain

Our award-winning rIM solution uses Internet of Things (IoT) technology to monitor the environmental condition of products in real time as they move through supply chains on land, sea, and air. It is widely used in pharmaceutical cold chains to monitor medical supplies, including vaccines.

rIM communicates with small IoT-enabled devices embedded with products and sends updates and alerts about more than a dozen environmental conditions, including temperature, humidity, light, orientation (tilt), and shock. It also monitors location, so it can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements. It can monitor at both the top level (e.g., case, pallet, truck) and the item level (e.g., syringe, packet, bottle), yielding true supply chain traceability and transparency.

Our CEO, Glenn Abood, was compelled to start rfxcel 17 years ago when he realized that consumers didn’t have a way to check the authenticity of their prescription drugs. Click here to learn more about rIM and our other solutions for the life sciences, all of which safeguard the pharma supply chain and protect consumers from potentially harmful products.

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!