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

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!

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

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 Joins the COVID-19 Healthcare Coalition

Washington, D.C., April 6, 2020. rfxcel, the global leader in supply chain track and trace 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

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.

Is It Time to Change Your Supply Chain Solution Provider?

Is your supply chain solution provider dropping the ball? Is it doing everything it can to help you meet global compliance like EU FMD, U.S. DSCSA, and Russia Chestny ZNAK? What about serialization, traceability, environmental monitoring, safety, data analytics, and your other key needs?

If you operate a pharma supply chain in the EU, Russia, the United States — anywhere — think about this:

An effective supply chain is like an effective athlete. It’s fast. It works toward goals. It always plays by the rules. It uses data to innovate and improve performance. It communicates with its team members. It focuses on excellence 24/7. It wins the game.

But to optimize its potential, it needs an effective coach. That coach is your solution provider, and rfxcel wants you to know that we have a 17-year track record of serialization, traceability, and supply chain excellence in the pharma industry. So, if you’re thinking it’s time for a change because your current solution provider isn’t getting you the wins you want, we want you to take a look at us.

Here’s why.

You’ll be fast and work toward goals

When you work with rfxcel, you’re fast right out of the gate and focused on your business goals. Our preconfigured and pre-validated solutions simplify the implementation process, meaning you’ll have a fully validated production solution in under 30 days. We listen to what your goals are and configure your solutions based on your guidance. You review and approve the implementation. Plus, our solutions are available in a variety of languages, which speeds implementation and boosts ease of use because people can work in their native language.

You’ll always “play by the rules” — you’ll always be compliant

rfxcel has the most comprehensive compliance reporting solution for your regulatory requirements. With us, you never have to worry if you’re compliant, no matter where you’re doing business. To illustrate, consider what we do for our pharmaceutical clients:

  • We deliver iron-clad global compliance: EU Falsified Medicines Directive (FMD); U.S. Drug Supply Chain Security Act (DSCSA); Russia’s National Track and Trace Digital System (Chestny ZNAK); India Drugs Authentication and Verification Application (DAVA); plus all regulations in China, South Korea, Brazil, Saudi Arabia, Turkey, and more.
  • We’ve sponsored pilots with U.S. Food and Drug Administration and the Brazilian Health Regulatory Agency (ANVISA)
  • We’ve processed more than 3 billion transactions and serial numbers.
  • The Top 6 pharma manufacturers in India have selected us as their solution provider.

A little more about Russia Chestny ZNAK

rfxcel is the leader in Russian compliance. We’ve been prepared for the country’s strict regulations since 2018, a year before they began rolling out. We’re one of few providers with in-country implementations. Over the last year, we tripled our workforce in Russia. That Moscow-based team provides our customers, which include major global consumer goods and pharmaceutical companies, the quickest time to market while fully automating their compliance reporting and assuring ongoing compliance. So, if you want to do business in Russia, rfxcel is your best choice for total supply chain compliance, optimization, and support.

You’ll use data to improve performance and innovate

Our full-stack rfxcel Traceability System software platform is one solution for your entire supply chain, enabling comprehensive serialization capabilities, true end-to-end traceability, compliance reporting, Internet of Things (IoT)-enabled environmental monitoring, and analytics from anywhere in the world. It can comprise up to eight discrete solutions that work in concert to harmonize, optimize, automate, and monitor virtually every aspect of your operations.

In other words, you will have around-the-clock access to rich, actionable data about everything in your supply chain, right down to the unit level. This is data you can use to improve performance, innovate your operations, and engage with consumers. Furthermore, our solutions support all industry and customized data formats, and we offer secured connections to exchange and manage/transform data.

You’ll connect and integrate with all your trading partners

With rfxcel, you’ll never be out of touch with your trading partners, no matter where they’re located. Thousands of companies are already connected to our network, which means almost instantaneous integration and communication across common trading partners. Our systems enable secure connections to exchange information, so your communications are always safeguarded. Most important, we have more than 70 data verifications that prevent bad data from entering your system. No garbage in means no garbage out.

You’ll get rfxcel’s world-class service and 24/7 support

Our industry-leading service doesn’t end after you’ve signed your contract and your system is implemented. Customer satisfaction is our No. 1 priority. We want you to be happy with our service, support, and products at all times.

Final thoughts

rfxcel is the coach you need to achieve peak supply chain performance. If your solution provider isn’t operating at this level, it’s probably time to think about switching teams. We deliver from one end of your supply chain to the other, whether it’s laboratory to patient, farm to table, or factory to retailer to point of purchase. We will help you meet compliance requirements and make your partners and customers happy. If your current provider isn’t delivering what you need, you need to contact us today.

COVID-19 (Coronavirus) and the Global Supply Chain: 5 Things to Know

COVID-19 has affected a wide array of industries and their supply chains but companies are doing as much as they can to help get these supply chains up and running again while also ensuring the safety of their workers. More hygiene measures, like wearing an N95 Respirator and carrying hand sanitizer, are being enforced to ensure no spread of the virus occurs while workers rush to bring back the supply of goods. No one knows how long COVID-19 will affect the global supply chain which is why it’s so important to work overtime ensuring things can get back to normality as soon as possible. A February 7 article in Forbes reported that 421 global companies, including 394 based in the United States, had discussed the COVID-19 outbreak in China during calls about first-quarter earnings. Their conclusion? The virus could have a negative impact on financial performance for that timeframe.

rfxcel is monitoring news about COVID-19. Below, we summarize five of the most recent developments. As we all know, the situation is changing every day – as do the key takeaways about how the virus is affecting global supply chains – so these are snapshots, not analyses, predictions, or conclusions.

We’ll continue following the situation, so check back often for updates.

1. Monday, Feb. 24: Potential U.S. Supply Chain Disruptions as More COVID-19 Cases Reported in China, Japan, and South Korea

China, Japan, and South Korea are major U.S. trading partners. Combined, these countries accounted for more than 25% of total American imports in 2019. Let’s break down the numbers from the U.S. Census Bureau to get an idea of the potential impacts on U.S. supply chains if factories in these countries were shut down for long periods.

China: No. 3 in total trade value in 2019
    • From 2018 to 2019, China’s trade with the United States fell 15.15 percent, from $654.36 billion to $555.25 billion.
    • In 2019, exports totaled $106.63 billion and imports totaled $448.62 billion (deficit of $342 billion).
    • Top 10 exports: civilian aircraft, parts; computer chips; soybeans; motor vehicles for transporting people; machinery, parts for semiconductor manufacturing; medical instruments for surgeons, dentists, vets; oil; plasma, vaccines, blood; medical equipment for physicals; medicines in individual dosage
    • Top 10 imports: cell phones, related equipment; computers; toys, children’s bicycles, games; TVs, computer monitors; motor vehicle parts; furniture, parts; seats, excluding barber, dental; electric water, space, soil heaters; lamp and lighting parts; computer parts
Japan: No. 4 in total trade value in 2019
    • Trade totaled $218.29 billion. Exports totaled $74.65 billion and imports totaled $143.64 billion (deficit of $68.98 billion).
    • Top 10 exports: civilian aircraft, parts; petroleum gases, other gaseous hydrocarbons; medical instruments for surgeons, dentists, vets; medicines in individual dosages; corn; machinery, parts for semiconductor manufacturing; pork meat, fresh, frozen or chilled; coal, briquettes; plasma, vaccines, blood; oil
    • Top 10 imports: motor vehicles for transporting people; motor vehicle parts; machinery, parts for semiconductor manufacturing; self-propelled heavy construction machinery; defense-related aircraft, parts; printers, all types, parts; value added to a returned import; medicines in individual dosages; motor vehicle engines; aircraft engines, engine parts
South Korea: No. 6 in total trade value in 2019
    • Trade totaled $134.41 billion. Exports totaled $56.9 billion and imports totaled $77.51 billion (deficit of $20.61 billion).
    • Top 10 exports: oil; machinery, parts for semiconductor manufacturing; computer chips; petroleum gases, other gaseous hydrocarbons; civilian aircraft, parts; motor vehicles for transporting people; frozen beef; medical instruments for surgeons, dentists, vets; gasoline, other fuels; acyclic alcohols
    • Top 10 imports: motor vehicles for transporting people; motor vehicle parts; gasoline, other fuels; computer parts; cell phones, related equipment; computer chips; plasma, vaccines, blood; unrecorded media for audio; rubber tires; refrigerators, freezers

2. Monday, Feb. 24: Shanghai introduces measures to help companies resume production and mitigate impact of COVID-19 outbreak

Local authorities in Shanghai’s Pudong New Area have introduced rent reduction, rent exemption, and other policies to help companies affected by the virus. The Pudong New Area is home to the Lujiazui Finance and Trade Zone and the Shanghai Stock Exchange, as well as the Port of Shanghai, the Shanghai Pudong International Airport, and the Zhangjiang Hi-Tech Park.

The Pudong New Area State-owned Assets Supervision and Administration Commission said more than 1 billion yuan (approximately $142 million) in rent reduction and exemption would benefit about 8,000 companies in the industry, retail, commerce, and technical services sectors.

According to officials, 66 percent of industrial enterprises, 93 percent of software information service companies, and more than 85 percent of foreign trade enterprises have resumed work in this key economic area.

In the nearby Lingang Special Area of China (Shanghai) Pilot Free Trade Zone, 971 companies have resumed operation and more than 40,000 employees have returned to work. Key sectors here include integrated circuits, artificial intelligence, biomedicine, aerospace, and new energy vehicles.

3. Friday, Feb. 21: Chinese President Xi Jinping says manufacturing supply chains should get help to resume output

At the meeting of the Communist Party Politburo on February 21, the Chinese president said the country must work to both contain the spread of COVID-19 and ensure that industry can resume output and meet economic targets. These comments came as businesses question Chinese suppliers’ ability to meet demand and consider finding other places to source materials.

“Priority should be given to ensure leading companies that are important in the global supply chain restore production and supply, maintaining the stability of the supply chain,” he said to the 25-member Politburo. “It is necessary to help key export enterprises resume work and production as soon as possible.”

4. Monday, Feb. 17: China has issued 1,600+ “force majeure certificates” to protect companies from legal damages arising from the COVID-19 outbreak

The China Council for the Promotion of International Trade (CCPIT) has issued 1,615 force majeure certificates to companies in more than 30 sectors, covering a total contract value of 109.9 billion yuan (approximately $15.7 billion).

Furthermore, China’s Ministry of Commerce has instructed six trade associations in the healthcare, textile, machinery, mining and other sectors to help with legal counseling and applying for the certificates.

A certificate protects a company that does not perform or only partially performs contractual duties by proving it is being affected by circumstances that are beyond its control. The CCPIT says its certificates are recognized by governments, customs organizations, trade associations ,and enterprises in more than 200 countries and regions.

5. Tuesday, Feb. 11: Dun and Bradstreet release white paper about COVID-19’s effect on global business

Here’s what the commercial data and analytics company estimates:

    • Approximately 90% of all active businesses in China are in the regions affected by COVID-19.
    • At least 51,000 companies around the world have one or more direct or Tier 1 suppliers in the affected region; 163 of these are Fortune 1000 companies.
    • At least 5 million companies have one or more Tier 2 suppliers in the affected region; 938 of these are Fortune 1000 companies.
    • Currently, 49,000 businesses in the affected region are branches or subsidiaries of companies headquartered outside China. Nearly half of these are based in Hong Kong, 19% are in the United States, 12% in Japan, and 5% in Germany. Other countries include the United Kingdom (including the Virgin Islands), the Cayman Islands, the Netherlands, Switzerland, and France.

 

rfxcel MobileTraceability App for Pharma: Mobile Data Capture from Virtually Any Location Optimizes Supply Chain Logistics and Patient Safety

rfxcel is dedicated to optimizing the pharmaceutical supply chain. We want to remove boundaries, improve data capture and usage, and ensure patient safety.

With our new and improved rfxcel MobileTraceability application, pharma companies, dispensers, and pharmacies can do all of these things — and much more.

rfxcel MobileTraceability brings our industry-leading track and trace capabilities to virtually any location, including places that traditionally may not have had absolute visibility in your supply chain, such as distribution centers, warehouses, pharmacies, and hospitals. It also brings the power of a digital supply chain, moving you away from paper records and streamlining your operations.

The app integrates the power of our signature Traceability System (rTS) with the built-in scanning capabilities of mobile devices and scanners. With rTS tracking and reporting capabilities on a mobile device, the workflow of the pharma supply chain is simplified. For example, manufacturers and distributors can perform critical tasks quickly and easily, such as verifying shipments and receipts, and aggregating/disaggregating pallets and cases.

rfxcel MobileTraceability supports multiple platforms, from ruggedized devices with optimized scanners to consumer devices with built-in cameras, such as smartphones. Now you can select devices that meet your needs and budget without comprising on performance.

With these capabilities literally right in their hands, dispensers can:

  • Ensure only legally compliant items are dispensed
  • Scan and verify dispensed products
  • Decommission products
  • Scan sealed bags to automatically decommission all packs inside

The app also offers key benefits to pharmacies. Its simple user interface makes it easy to use, reducing the chance of errors and false override of alerts. It also facilitates intense collaboration and coordination externally and internally to:

  • Achieve regulatory compliance
  • Improve risk management, recall management, and inventory management
  • Automate and review distribution flows and processes
  • Create specialized receiving capabilities
  • Ensure patient safety with store returns and recalls functionality
  • Gain true end-to-end supply chain traceability

rfxcel MobileTraceability adapts to any workflow, transforming how you manage your supply chain. The pharma industry has unique demands, and a one-size-fits-all approach just won’t work. The app allows us to be as flexible as you need us to be and to deliver granular visibility and flexibility anywhere your supply chain goes. Contact us today to learn more about what rfxcel MobileTraceability can do for you.

How a Full-Stack Supply Chain Track-and-Trace Solution Benefits the Food & Beverage and Pharma Industries

The food & beverage (F&B) and pharma industries aren’t quite polar opposites, but they are very different. This includes their supply chains.

For example, F&B companies must get their products to grocery stores, hotels, airports, restaurants, and other “consumer-centric” clients, while pharma companies’ primary customers are hospitals, clinics, pharmacies, and other stakeholders in the health care system. Their products also have different environmental and compliance requirements.

But there are similarities. Both industries want to ensure the purity and safety of their products. Both want to get their products to end users quickly, securely, and on time. Both work with diverse trading partners, including wholesalers and distributors. Both want their supply chains to optimize operations and boost bottom lines.

And there’s one more similarity: Both can benefit from a full-stack supply chain solution — like our signature rfxcel Traceability System (rTS) platform.

What is a “full-stack” supply chain solution?

A full-stack supply chain solution gives customers a complete, integrated set of technologies to control their entire supply chain. rTS is a full-stack solution comprising software that empowers companies to see deeply into their supply chains in real time. It yields data that can optimize operations, and gives peace of mind because everything is managed and accessible in one secure, private cloud-based location.

Furthermore, full-stack solutions are easily customizable and system validation is automated based on customer requirements. Users determine the features they need and choose the appropriate components. For example, rTS includes solutions that are critical for both F&B and pharma, such as rfxcel Serialization Processing, rfxcel Compliance Management, and rfxcel Analytics. But it also includes products designed for each industry, such as rfxcel Raw Ingredients Traceability for F&B and rfxcel Verification Router Service (rVRS) for pharma.

What are the benefits of a full-stack solution?

Probably the greatest benefit of a full-stack supply chain solution is “all-in-one” power and convenience. Instead of a piecemeal approach to supply chain management — using different providers for different solutions — a full-stack solution centralizes your operations.

F&B and pharma companies have to ask themselves, “Do I really want to spend my time finding a different tool for every task? One for compliance, one for serialization, one for data analytics, one for scanning, and on and on and on?”

They also have to ask what problems this approach might cause. Can they be certain their solution providers can communicate with one another? Are the providers actually in competition with one another? Can they share data quickly and securely? If something goes wrong with one solution, will the problem cascade throughout the supply chain — and can they find the right person to fix it?

Another advantage is that a full-stack solution provider will understand your needs much better than a disparate collection of providers. They can analyze your entire supply chain, identify your needs, and tailor just the right combination of solutions to meet your goals. It’s a holistic approach that sees both the individual components of your supply chain and the end-to-end “big picture,” from manufacturing to the consumer.

Plus, you’ll have just one point of contact for all your inquiries and support. If you have a question or a problem, you’ll know that you’re contacting the right person and you’ll get answers quickly.

rfxcel’s full-stack traceability solutions in action

Let’s illustrate some benefits of our full-stack traceability solution by highlighting rTS, rIM, and our MobileTraceability app. With these, pharma and F&B companies have all bases covered in a seamless, integrated, end-to-end supply chain traceability solution.

With rTS, pharma companies will know they’re compliant with regulations everywhere they do business, such as the Drug Supply Chain Security Act (DSCSA) in the USA, the Falsified Medicines Directive (FMD) in the EU, as well as regulations in Russia, Saudi Arabia, China, Brazil, and other countries. F&B companies will know they’re meeting the requirements of the U.S. Food and Drug Administration’s Food Safety Modernization Act (FSMA), the UK’s Food Standards Agency, the Canadian Food Inspection Agency, and others. They’ll also be compliant with GS1 standards and their customers’ requirements.

Using rIM to monitor products in real time as they move through the supply chain, both industries can ensure they’re meeting environmental requirements, such as temperature and humidity parameters. If a problem arises, rIM sends an alert and they can take immediate action.

Key actors at every node of the supply chain can use our MobileTraceability app to scan and record events, track products, and manage items down to the unit level. For example, using the app on a smartphone with a scanner, pharma stakeholders can verify, decommission, and aggregate serialized products at any stage of the supply chain. A F&B stakeholder can record data about raw materials (e.g., batch number, supplier, date of arrival, expiration, and analytics) and trace any ingredient that’s part of the finished good.

A full-stack supply chain solution has numerous benefits for F&B and pharma — as well as any other industry that wants to simplify, coordinate, and optimize its supply chain. To learn more about how our full-stack rTS platform can transform your supply chain, contact us today!