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rfxcel Enters into Acquisition Agreement with Antares Vision Group

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The combination of rfxcel’s industry-leading traceability software platform and Antares Vision’s solutions for intelligent track and trace will create significant value for customers.

Reno, Nevada, Feb. 19, 2021 (EINPRESSWIRE). rfxcel, a global leader in digital supply chain traceability solutions, today announced that it had entered into an acquisition agreement with Italy’s Antares Vision Group, a leading global provider of intelligent track and trace, inspection, and smart data management solutions for the life sciences and food and beverage sectors.

rfxcel CEO Glenn Abood said the agreement marked the start of an expansive era for the company he co-founded with Chief Strategy Officer Jack Tarkoff in 2003. “This is an exciting new chapter for rfxcel,” he said, “a time for the company and our customers to look to the future.

“Becoming part of Antares Vision Group will give us new ways to strengthen our relationships with our customers and provide them with enhanced solutions as they do their important work in the life sciences, food and beverage, consumer goods, and government industries. Plus,” Abood continued, “the integration of our companies’ capabilities will enable us to drive into new markets and geographies as the undisputed leader in supply chain track and trace solutions. It really is a ‘win-win’ for our global teams and our customers.”

The Antares Vision Group will leverage rfxcel’s capabilities and signature rfxcel Traceability System (rTS) software suite to help customers accelerate their transition toward digital and sustainable supply chains characterized by full transparency and visibility. Together, the companies will provide a full stack, end-to-end digital supply chain solution that will optimize and streamline customers’ operations while providing complete end-to-end visibility, from product ingredients and raw materials to the end customer experience.

rTS is a digital supply chain visibility platform comprising up to eight discrete solutions that work in concert to harmonize, optimize, automate, and monitor virtually every aspect of supply chain operations, including serialization, regulatory compliance, Internet of Things (IoT)-enabled monitoring, and raw materials and finished goods traceability. rfxcel also offers a Mobile Traceability app that extends the power of rTS to users at every node of the supply chain, from remote fields and warehouses to retail outlets.

Emidio Zorzella, chairman and CEO of Antares Vision, said he and co-founder Massimo Bonardi were “delighted” about the agreement with rfxcel. “Demand for traceability and serialized products and services has increased significantly over the last few years,” he said, “and this transaction accelerates our ability to offer best-in-class propositions in all our key reference sectors, life science and food and beverage. We look forward to welcoming the management and employees of rfxcel to the Antares Vision Group and working together to serve our customers across the world.”

Abood added that both companies shared the same goals and Antares Vision would help rfxcel accelerate its plans. “The rfxcel management team is delighted to join with Antares Vision to offer customers the most complete end-to-end solution for track and trace on the market today.”

For more information about the acquisition agreement or the companies’ solutions, contact Herb Wong, rfxcel’s vice president of marketing and strategic initiatives, at hwong@rfxcel.com or 925-824-0300.

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, 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 track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.

About Antares Vision

Listed since April 2019 on the AIM Italia market of the Italian Stock Exchange, Antares Vision Group guarantees the protection of products, people and brands through inspection systems for quality control, track and trace solutions for anti-counterfeiting and supply chain transparency, smart data management tools for maximized efficiency and digitalization of the supply chain, from the point of production to the end consumer. The Antares Vision Group is active in the life science sector, including the pharmaceutical, medical device, and hospital segments, as well as in other industries, including, primarily, food and beverage, cosmetics, and in consumer-packaged goods. The Group reaches over 60 countries worldwide with complete and flexible solutions, hardware, and software, with related services: it has five offices in Italy (Brescia, Parma, Piacenza, Latina and Vicenza), 15 foreign branches (Germany [2], France [2], USA [3], Latin America [2], India, Russia, Hong Kong, China, Croatia, and Serbia), three Innovation and Research Centers (Italy) and a worldwide network of more than 40 partners. With the 20 years of experience in vision technologies of the two founding partners, the Antares Vision Group is the supplier of 10 of the 20 leading pharmaceutical companies in the world (by turnover), with more than 25,000 inspection systems, which ensure everyday product safety and quality, 6,500 quality controls, and more than 3,500 serialization modules on lines installed all over the world. With the aim of continuing and supporting the growth and development strategy, during 2019, Antares Vision finalized participation agreements with T2 Software, a Brazilian company specialized in smart data management solutions, and Orobix, an Italian company leader in artificial intelligence services, and acquired 100 percent of FT System, leader in control and inspection in the beverage sector. In 2020, Antares Vision acquired 82.83 percent of Tradeticity, a Croatian company specialized in software management of traceability and serialization processes, 100 percent of Convel, an Italian company specialized in automated inspection machines for the pharmaceutical industry, the assets of Adents High Tech International, a French company specialized in software for serialization and traceability, and 100 percent of Applied Vision, a global leader in inspection systems for glass and metal containers in food and beverage. In 2019, Emidio Zorzella and Massimo Bonardi won the Ernst & Young “Entrepreneur of the Year” award for innovation. For more info: www.antaresvision.com.

What Does the EU COVID-19 Vaccine Distribution Plan Look Like?

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The EU announced its COVID-19 vaccine strategy on June 17, 2020. Among other things, it called for ensuring the quality, safety, and efficacy of vaccines, securing quick access to vaccines, and ensuring equitable access to an affordable vaccine as early as possible. It also called for adapting the EU’s regulatory framework and taking advantage of regulatory flexibility to address the urgent need.

Let’s take a look at what the EU has said about its COVID-19 vaccine distribution plan and answer some frequently asked questions about its vaccine administration.

What vaccines are being used in the EU?

The European Commission says it wants to “build a diversified portfolio of vaccines based on different technologies, to increase the chances that one or more of the vaccine candidates are approved by EMA.”

The EU authorized the BioNTech-Pfizer COVID-19 vaccine on December 21, 2020, and the Moderna vaccine on January 6, 2021. It did this after the European Medicines Agency (EMA) assessed their safety, quality, and efficacy.

On January 8, the Commission reported that it had concluded contracts for 600 million doses of the BioNTech-Pfizer vaccine and 160 million doses of Moderna’s vaccine. It also reported securing contracts for millions of doses from AstraZeneca, Sanofi-GSK, Johnson and Johnson, and CureVac, and that it had concluded “exploratory talks” with Novavax and Valneva.

Then, on January 29, the Commission announced that AstraZeneca agreed to publish the redacted contract it signed on August 27, 2020, and that CureVac agreed to publish the Advance Purchase Agreement with the EU.

The Commission says it has secured more than 2.3 billion doses of COVID-19 vaccines, adding that if all the vaccine candidates are found to be safe and effective, EU Member States could donate part of their doses to lower- and middle-income countries.

Who will receive the vaccine and when?

As of January 8, the EU said that all Member States would have access to COVID-19 vaccines at the same time, based on the size of their population. On January 29, the Commission enacted a measure requiring Member States to authorize vaccine exports, stating this will “ensure timely access to COVID-19 vaccines for all EU citizens and … tackle the current lack of transparency of vaccine exports outside the EU.”

The Commission says the number of doses will be limited during the initial stages the immunization effort and before production can be ramped up. As in other countries, authorities have said that there will not be enough doses to vaccinate everybody right away; it will take time.

Most members have defined who will get the vaccine first and are further refining sub-groups to assign priority. Frontline healthcare professionals and people over 80 years old top the lists. For more insight about the rollout, see this December 2020 report from the European Centre for Disease Prevention and Control about preparedness in the EU, the European Economic Area, and the UK. The Centre also has a useful “Situation Update” page that tracks the pandemic in the EU.

Vaccine supplies will increase over time, the Commission says, and all adults should be able to get vaccinated during 2021. It predicts that at least 80 percent of people over the age of 80 and 80 percent of health and social care professionals should be vaccinated by March 2021. By this summer, the Commission says 70 percent of the EU’s adult population should be vaccinated. These projections, however, are probably optimistic, as the rollout has been slow and fewer doses than expected have been delivered.

Final thoughts

As we said in our blog post about COVID-19 vaccine distribution in the United States, the world is in an “all hands on deck” situation. We like to think we’ve been part of the effort since the pandemic began.

In April 2020, we joined the COVID-19 Healthcare Coalition, offering our Accurate Immunization Management (AIM) and rfxcel Integrated Monitoring (rIM) solutions. rIM is a real-time environmental monitoring solution that uses Internet of Things (IoT)-enabled devices to monitor products while they’re in transit; it’s a powerful, ideal solution for the pharma cold chain, which is vital to vaccine distribution.

AIM ensures that the right person gets the right vaccine at the right time. It can track COVID-19 vaccines — indeed, any vaccine — in any supply chain, monitor inventory, and facilitate safe, timely delivery to any location. We designed AIM to be fast, flexible, and compliant in any country. At a time when the world is depending on supply chains to function at peak performance, AIM is a tool to help get vaccines properly delivered and dispensed.

Furthermore, our signature rfxcel Traceability System has proven itself in the pharma supply chain, helping ensure products are safe and legitimate and that consumers know exactly what they’re getting. Contact us today to learn more our solutions and how we can help you secure your supply chain, no matter what industry you’re in or where you do business.

How the COVID-19 Vaccine Track and Trace Systems Work in the United States

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On December 11, the Food and Drug Administration (FDA) issued an emergency use authorization for a COVID-19 vaccine in the United States. The Pfizer vaccine was the first vaccine made available to the public, followed by Moderna’s vaccine.

There are many challenges for U.S. track and trace systems monitoring COVID-19 vaccine shipments. There’s also the additional challenge of keeping tabs on who receives the vaccine and when, especially as the program is being conducted through both state and federal data networks.

Let’s take a look at how the United States is implementing its track and trace systems and address the unique challenges of vaccine distribution.

What track and trace systems are the United States using?

The United States is using federal immune registry systems and connecting them with a new project called the Immunization Gateway, or IZ Gateway. Put simply, the system enables providers, consumers, and other stakeholders to exchange immunization data. It’s sponsored by the Centers for Disease Control and Prevention’s Immunization Information Systems Support Branch and led by the U.S. Department of Health and Human Services (HHS) Office of the Chief Technology Officer.

IZ Gateway connects 64 Immunization Information Systems (IIS), which consolidate and “deduplicate” immunization information. IIS also have forecasting algorithms that can help people stay current on their vaccines. The IZ Gateway’s centralized technical infrastructure facilitates data exchange through an intelligent message router that connects the IIS to one another, connects large multi-jurisdictional provider organizations to the IIS, and connects the IIS to consumers.

The HHS says the IZ Gateway “aims to increase the availability and volume of complete and accurate immunization data stored within IIS and available to providers and consumers regardless of their jurisdictional boundaries.” Prisons and veteran’s affairs hospitals are also connected to the system.

The main challenge to the U.S. track and trace system

As we know, tracking and tracing the COVID-19 vaccine isn’t an easy task. There have been a variety of concerns, including securing pharma cold chain infrastructure and providing track and trace technology with real-time environmental monitoring, such as our rfxcel Integrated Monitoring solution.

However, two challenges have remained at the forefront of the conversation: the sheer scale of the immunization effort and the two-dose requirement. Although the IZ Gateway creates a nationwide network that can track if a person has received more than one dose, government, providers, and every other vested stakeholder should anticipate mistakes and inaccuracies and do everything within their power to optimize vaccine distribution and administration.

rfxcel’s Accurate Immunization Management (AIM) is one solution that can help. AIM is an automated, cloud-based solution that tracks the dispensing of vaccines in the supply chain. It seamlessly integrates with IIS, Electronic Health Records (EHRs), Allscripts, Nextgen, Urochart, Meridian, and iSalus, adding another layer of track and trace protection to vaccine distribution.

Final thoughts

COVID-19 vaccine distribution is an “all hands on deck” situation. Our signature rfxcel Traceability System has proven itself time and again in the pharma supply chain, helping ensure products are safe and legitimate and that consumers know exactly what they’re getting.

Now, AIM ensures that the right person gets the right vaccine at the right time. It can track COVID-19 vaccines — indeed, any vaccine — in any supply chain, monitor inventory, and facilitate safe, timely delivery to any location. We designed AIM to be fast, flexible, and compliant in any country. At a time when the world is depending on supply chains to function at peak performance, AIM is a tool to help get vaccines properly delivered and dispensed.

Contact us today to learn more about AIM, our rfxcel Traceability System and rfxcel Integrated Monitoring, and our other supply chain solutions.

Russia Pharma Serialization Update: “Notification Mode” Expedites Product Circulation

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Russia pharma serialization has been underway for a little more than three years. The country’s National Track and Trace Digital System, which is known as Chestny ZNAK and covers a dozen industries, has been continually tweaked and refined since it was created a little more than three years ago.

Some important updates to Russia pharma serialization were made public toward the end of 2020. Here’s a quick rundown of what the government announced.

“Notification mode” will simplify Russia pharma serialization processes

As we noted last year, Russia’s Drug Circulation Monitoring System (MDLP) was compelled to develop new reporting requirements after technical problems created serious issues in the pharma supply chain.

In late October, the MDLP moved into so-called “notification mode” to help supply chain actors continue importing, distributing, and selling medicines in the event of errors or failures in Chestny ZNAK’s reporting system. This applied to over-the-counter and prescription medicines manufactured in Russia or imported into the country, including from the Eurasian Economic Union (EAEU).

Then, in early November, Decree 1779, “On Amendments to the Regulation on the Monitoring System for the Movement of Medicines for Medical Use,” consolidated measures to simplify and expedite reporting. This is why notification mode has also been referred to as “simplification mode” for Russia pharma serialization.

In essence, stakeholders can proceed with distribution or dispensing 15 minutes after they submit the required product information to the Government Information System for Marking (GIS MT), which catalogs all marked goods, even if they do not receive confirmation that the information has been accepted/approved in the system. (The “product information” pertains to Russia pharma serialization requirements, such as serial numbers and Global Trade Item Numbers.) The decree also simplifies importation, giving custom officials a 2-hour window to request product information.

For now, these Russia pharma serialization rules are to remain in effect until July 1, 2021. After that, notification mode will stop.

Final thoughts

As the leader in Russia pharma serialization, rfxcel knows the regulations are stringent and challenging. To help, we offer useful resources online, like this refresher course and white papers and webinars that explain the regulations in easy-to-understand language.

These are great places to start, but the best way to ensure you’re prepared to comply with Russia pharma serialization laws is to talk with us directly. Consider our credentials:

  • We’re an official integration, software, and tested solution partner with the CRPT.
  • We’ve demonstrated that our solutions, including our signature rfxcel Traceability System (rTS) and Compliance Management (rCM), can meet the stringent Russia pharma serialization requirements and ensure you stay compliant.
  • rTS works seamlessly with Chestny ZNAK, including a Russian-language user interface that makes integration and startup much quicker.
  • We’ve prepared for Russia pharma serialization and Chestny ZNAK since 2018.
  • We’re one of the few providers with active pharma implementations in Russia.
  • We’ve tripled our workforce in Russia over the last year. Our team in Moscow provides our clients, which include major global pharmaceutical and consumer goods companies, the quickest time to market while fully automating their compliance reporting.

Contact us today learn more about how we can help you with Russia pharma serialization and Chestny ZNAK compliance. No matter how far along you are in your preparations to comply, you should talk to us — even if you’re already working with another provider. Our powerful software ensures you’ll be prepared and always be compliant with Russia’s complex regulations.

rfxcel Responds to Unprecedented Cold Chain Requirements and Logistics Challenges as COVID-19 Vaccine Distribution Nears

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Reno, Nevada, Dec. 2, 2020. rfxcel, the global leader in digital supply chain traceability solutions, continues to address cold chain and logistical challenges it anticipates will arise from the first widespread distribution of COVID-19 vaccines. The company has been preparing for a “vaccine surge” since the pandemic began to ensure it can respond to customer and industry needs when distribution begins to exert pressure on supply chains.

“The pandemic has revealed shortcomings in every supply chain, and we’ve seen increased competition for resources,” said rfxcel CEO and Co-Founder Glenn Abood. “We’ve worked with our global customers in pharma/life sciences, food and beverage, consumer goods, and government to keep their operations responsive and nimble. Now, we’re prepared to address additional stresses distribution of COVID-19 vaccines could create as the call for ‘all hands on deck’ commences and already scarce resources are redirected for the effort.”

rfxcel has provided traceability solutions since 2003. Its rfxcel Traceability System comprises discrete solutions that work in concert to harmonize, optimize, automate, and monitor supply chain operations, including serialization, compliance, environmental monitoring, raw materials traceability, and data analytics.

The company’s Integrated Monitoring (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. 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, location, humidity, light, and shock. It can alert users about route diversions and ensure logistics providers remain in compliance with delivery agreements.

rfxcel has also developed Accurate Immunization Management (AIM), an automated, cloud-based solution that tracks the dispensing of vaccines. It 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. Because it is automated, users can be up and running with virtually no training, ensuring quick implementation in mission-critical locations.

“We want to provide foolproof traceability,” Abood said. “Today, it’s more important than ever to be able to question, examine, and control every part of the supply chain, which is what our rfxcel Traceability System platform provides with solutions such as rIM and AIM.”

For more information about rfxcel’s Traceability System, rIM, AIM, and other solutions, contact Herb Wong, vice president of marketing and strategic initiatives, at hwong@rfxcel.com or 925-824-0300.

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies build and manage their digital supply chain, 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 track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.

Industry Reaction to Delayed Enforcement of DSCSA Saleable Returns

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The Healthcare Distribution Alliance (HDA) sponsored a meeting on October 28 with more than 100 pharma industry stakeholders to discuss how the Food and Drug Administration’s (FDA) 3-year delay of enforcing the U.S. Drug Supply Chain Security Act (DSCSA) Saleable Returns Verification Requirement will affect its constituents.

This was the first formal meeting about the FDA announcement and marked the beginning of industry discussion that will no doubt continue well into the future. Below are some of the key points raised at the meeting:

Continue with the VRS. The prevailing sentiment is to continue the Verification Router Service (VRS) effort. The enforcement delay was not intended to stop progress, but to give the industry time to ensure readiness.

The industry needs a plan. As one meeting participant correctly called out, the intent to make progress is not good enough. “We need a plan,” they said. To jumpstart this effort, rfxcel and other VRS providers will draft a 2021 road map to work toward DSCSA readiness. The road map will focus on the VRS, but may also address authorized trading partners (ATPs) and other requirements.

VRS is still a “go.” Will the pharma industry really need the VRS in 2023, the year the DSCSA stipulates full serialization of the pharma supply chain? After a healthy discussion, the consensus was that, yes, the VRS will most likely be necessary. Some in the industry anticipated the “retirement” of VRS in 2023 because wholesale distributors would at that time be performing their own verification of serial numbers. However, not all wholesale distributors agreed with this assessment.

Final thoughts

For details about the FDA’s October 23 announcement, see our blog post. And visit our website regularly for more updates about the Saleable Returns Verification Requirement and the VRS.

rfxcel is the industry leader in DSCSA compliance and the VRS. If you have any questions about the delay and what you need to do to be ready for 2023, contact us today.

FDA Delays Enforcement of DSCSA Saleable Returns Requirement

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Note: For the latest industry reaction to the FDA’s announcement, read our update here.

In a policy document published on October 23, the U.S. Food and Drug Administration (FDA) announced it was delaying enforcement of key aspects of the Drug Supply Chain Security Act (DSCSA) that will affect wholesale distributors and dispensers. The regulations were due to go into effect on November 27 of this year; now they won’t be enforced until November 27, 2023.

The delay, the second since 2019, pertains to the requirement to verify saleable returns under the DSCSA law. It also included guidance for wholesale distributors concerning transaction statements under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Here are the details.

Wholesale distributors: product identifiers

The FDA announced that it did “not intend to take action against” wholesale distributors that did not verify product identifiers before further distributing returned products as required under the DSCSA.

It explained that wholesale distributors, other trading partners, and stakeholders had expressed concern about industry readiness to implement the Saleable Returns Verification Requirement since the delay in November 2019. Specifically:

  • Challenges developing interoperable, electronic systems to enable verification and achieve interoperability between networks
  • More time needed to test verification systems using real-time volumes of returned product with all trading partners
  • Significant delays testing verification systems due to the COVID-19 pandemic, especially because logistics and supply chain experts were reassigned from DSCSA preparation to responding to the pandemic

Wholesale distributors: transaction statements

The FDA also addressed transaction statements under the FD&C Act. This is a little complicated, so we’ll take it one step at a time.

Section 582 of the FD&C Act requires manufacturers, repackagers, wholesale distributors, and dispensers to exchange transaction information, transaction history, and a transaction statement — known collectively as “T3 information” — for transactions involving certain prescription drugs.

Section 581 of the FD&C Act requires transaction statements to include a statement that the entity transferring ownership — wholesale distributors in this case — had systems and processes in place to comply with verification requirements under Section 582.

Now, “prior to November 27, 2023, [the] FDA does not intend to take action against” wholesale distributors whose transaction statements do not include the statement required under Section 581. See pp. 7–8 of today’s announcement for full details about this change.

Distributors & Dispensers: product identifiers for suspect/illegitimate products

Distributors have also received a 3-year reprieve concerning requirements for product identifiers. The FDA said it did “not intend to take action against distributors that do not verify product identifiers prior to further distributing returned product.

Furthermore, the FDA won’t take action against dispensers that “do not verify the statutorily designated portion of product identifiers of suspect or illegitimate product before November 27, 2023.” Section 582 of the FD&C Act stipulates how dispensers must investigate suspect and illegitimate products.

Final thoughts

If you’re a wholesale distributor or dispenser and have questions about these changes to the saleable returns verification requirement — or anything else about the DSCSA — we can help. rfxcel is the industry thought leader in DSCSA compliance, including the Verification Router Service (VRS), and we are ready to help you make the most of this extra time.

Contact us today and our supply chain experts will show you how our award-winning rfxcel Traceability System will fully prepare you for the DSCSA. We’ll answer your questions, address your concerns, and customize a solution that will ensure you’re compliant. The extra breathing room is nice, but the time to act is now.

DSCSA 2020: November Is Coming & It’s Time to Comply

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Note: The FDA has delayed enforcement of the DSCSA for dispensers and wholesale distributors. Read the details here.

The next deadline for the U.S. Drug Supply Chain Security Act (DSCSA) is November 27. That means there’s only a little more than a month to comply. DSCSA 2020 means different things to different stakeholders. Here’s what you have to do if you’re a dispenser or a wholesale distributor.

DSCSA 2020 for dispensers (pharmacies, clinics, hospitals, healthcare systems, etc.)

If you’re a dispenser — an independent pharmacy or a pharmacy in a hospital, clinic, grocery store, or anywhere else — DSCSA 2020 means that you must be able to authenticate and verify all the medicines you buy before you can sell them to consumers.

You must meet two key requirements by November 27:

  1. You can buy and sell only products encoded with product identifiers (PIs). A PI contains a lot number, an expiration date, and the product’s standardized numerical identifier (SNI). The SNI includes the National Drug Code and a unique alphanumeric serial number.
  2. You must verify every product at the package level, including the SNI.

Because the clock is ticking and we want to help, our DSCSA Strategic Advisor Brian Files is hosting a special DSCSA 2020 Q&A session this Thursday, Oct. 15, at 12 p.m. PST/3 p.m. EST. Send your questions today, and Brian will answer them in this live Zoom event.

If you haven’t begun to prepare, Brain will tell you it’s critical to start now. Contact us. We have a proven a track record of success with DSCSA compliance. We have in-house DSCSA experts who will analyze your needs, explain what you need to do, and build a scalable solution tailored to your operations.

Also keep in mind that you must also be able to exchange “T3” information about every drug you buy and who handled it each time it changes ownership in the United States. T3 information” includes Transaction Information (TI) about a product (e.g., proprietary or established name or names and the strength and dosage form); Transaction History (TH), an electronic statement with the TI for every transaction going back to the manufacturer; and a Transaction Statement (TS), which is an electronic statement confirming the entity transferring ownership. We know all about T3 information. Read more about it here.

DSCSA 2020 for wholesale distributors

If you’re a wholesale distributor, DSCSA 2020 means must verify returned products before you can reintroduce them to the supply chain. You’ll do this through the Verification Router Service (VRS), an automated system that verifies if a PI is valid. You’ll initiate a verification request to a manufacturer to verify the PI of the returned product.

There are multiple VRS providers, and each is responsible for determining if a specific group of PIs is valid.  You can call any VRS provider to verify if a PI is valid, but if they do not manage the PI in question, they will automatically route your verification request to the provider that does. All of this happens in real time, and VRS ensures that information is accurate and up to date.

rfxcel is the thought leader in the DSCSA saleable returns verification requirement and the VRS. We implemented a VRS pilot for the Food and Drug Administration and extended industry testing of the VRS. Contact us today, and we’ll share our expertise in supply chain track and trace, serialization, and compliance solutions to make sure you’re ready for DSCSA 2020. We’ll also be happy to share our final report about the FDA pilot.

Final thoughts

The DSCSA was enacted to promote patient and consumer safety by facilitating product tracing in the pharma supply chain and ensuring the authenticity of products. DSCSA 2020 is the next step in verifying drugs.

November 27 will be here before you know it. If you’re a dispenser or a wholesale distributor, we can help. Reach out to us now and our supply chain experts will show you how our award-winning rfxcel Traceability System can ensure you comply with DSCSA 2020.

rfxcel Welcomes Lincoln Manning as Chief Revenue Officer

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Reno, Nevada, Sept. 17, 2020. rfxcel, the global leader in digital supply chain traceability solutions, today announced that Lincoln Manning has joined its executive team as chief revenue officer. Mr. Manning will be responsible for all aspects of revenue generation, including worldwide sales, ecosystem partnerships, sales operations, and systems engineering for the company’s verticals, which include the life sciences (pharmaceuticals and medical devices), food and beverage, government, and consumer goods.

“We are glad to have Lincoln on our team,” said rfxcel CEO and Co-Founder Glenn Abood. “He brings a wealth of experience from diverse industries that he’ll be able to leverage across rfxcel. We are particularly excited about his devotion to and excellence in anticipating what customers need and doing what it takes to ensure they succeed. This is one of our corporate values.

“Lincoln also has a track record of building and strengthening sales teams. Our sales teams are solid in every market, but Lincoln will take them to the next level, helping us maintain our leadership where we’re already established and build our presence where we’re still growing.”

Prior to joining rfxcel, Mr. Manning held executive-level positions at software and digital marketing companies. He led sales, marketing, and customer success teams to increase revenue, reinvent business ecosystems, navigate post-merger corporate change, and reset reseller channels.

“There couldn’t be a more perfect time to be joining rfxcel,” Mr. Manning said. “Our mission of keeping the supply chain safe in key verticals is more important today than ever. I believe rfxcel is uniquely positioned globally to ensure products are safely delivered to patients and consumers, because of our agility and ability to respond to customer needs in today’s ever-changing environment.”

Mr. Abood co-founded rfxcel with Chief Strategy Officer Jack Tarkoff in 2003, so Mr. Manning joins the company as it celebrates 17 years of supply chain innovations and growth. Recent successes include conducting major pharma pilots for the U.S. Food and Drug Administration and the Brazilian government; tripling the size of its team in Russia and being named an official software and integration partner of the Center for Research in Perspective Technologies (CRPT), which operates Russia’s National Track and Trace Digital System (Chestny ZNAK); releasing the latest version of its award-winning rfxcel Traceability Solution; increasing its presence in the Middle East; and being named 2020 Software Company of the Year by Nevada’s Center for Entrepreneurship and Technology (NCET).

“Lincoln’s joining us at a busy time,” Abood said. “We’re keeping our customers’ supply chains running during the pandemic, improving our products and developing new solutions, and expanding our operations globally. Lincoln will be a huge asset as we continue to secure and optimize the pharma, food and beverage, government, and consumer goods supply chains. By strengthening our commitment to our customers, he’ll strengthen rfxcel. We’re all excited to have him on the team.”

For more information about rfxcel’s solutions, contact Herb Wong, vice president of marketing and strategic initiatives, at hwong@rfxcel.com or 925-824-0300.

 

About rfxcel

Founded in 2003, rfxcel provides leading-edge software solutions to help companies build and manage every aspect of a digital supply chain, 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 track and trace, environmental monitoring, regulatory compliance, serialization, and visibility. The company is headquartered in the United States and has offices in the United Kingdom, the EU, Latin America, Russia, India, Japan, the Middle East, and the Asia-Pacific region.

Unlocking Efficiency in the Supply Chain: The Role of L1-L5 Solution Provider

Posted on by rfxadmin

Jargon. For better or for worse, it’s a fact of life — more so for people like us who work in the highly technical field of supply chain management. From ANSI to XML, an alphabet soup of shop talk can rain down upon us without warning, often leaving us scratching our heads (or at least searching online). L1-L5 solution provider? What does that mean?

And if we say rfxcel is an L4 and L5 solution provider, what does that mean? With as little jargon as possible, let’s find out.

What does the “L” stand for in L1-L5 solution provider?

The “L” in “L1-L5 solution provider” stands for “level,” as in the level of serialization in a supply chain. To put a finer point on it, it means the level of serialization and information management in a supply chain. And if you hadn’t guessed, there are five levels:

  • Level 1: Device
  • Level 2: Packaging
  • Level 3: Site
  • Level 4: Enterprise
  • Level 5: Network

The list above progresses from the smallest or most localized level, the L1 device level, to the most expansive and all-encompassing level, the L5 network level. Generally, L1, L2, and L3 are grouped together because they’re happening where products are created and packaged; L4 and L5 are paired together in the realm where those products enter the greater supply chain to make their way to their final destinations.

When talking about L1-L5, let’s work backwards from largest to smallest. This way, we can “zoom in on” the details and put everything in a more vivid context.

Level 5: Network

L5 is where rfxcel has its roots and where we built our reputation for supply chain excellence. The network level is where all serialization and regulatory data is managed, including with your trading partners, regulatory authorities and their repositories, and customers. It ensures you’re communicating with partners and complying with regulations.

Level 4: Enterprise

rfxcel’s roots also run deep in L4, which manages and verifies all your serialization and regulatory data/compliance reporting before sending it to L5. It also generates your serial numbers and manages all your business processes. When you design your solutions for L1, L2, and L3, you must decide how they will integrate with your L4 solution.

Level 3: Site

This is where we enter your actual manufacturing facilities and processes. L3 manages the line systems (i.e., L2) at your site to ensure that they are working optimally. L3 is optional; if present, it serves as the “middle man” between L4 and L2, requesting serial numbers from the former and allocating them to the latter.  L3 will also verify the L2 data before it is submitted to L4.

Level 2: Packaging

L2 systems control the L1 hardware and manage the serial numbers which are printed and applied on packages by L1 devices. L2 systems will communicate with the L4 (or L3,f present) to send/receive serial numbers as needed.

Level 1: Device

L1 comprises devices on a packaging line that enable serial numbers to be affixed to packaging and products, such as barcode printers, label printers, and labelers. It also includes cameras and scanners used for quality control, such as visual inspections of products and labeling.

rfxcel is an L4 and L5 solution provider that integrates with L2 and L3

As we said above, we’ve built a reputation for excellence for L4 and L5, the enterprise and network levels. This is our business: Creating innovative software solutions that optimize key supply chain requirements and functions — from the nuts and bolts of serialization and regulatory compliance to environmental monitoring and data analytics — and bring true end-to-end track and trace capabilities to any supply chain.

Our solutions ensure you’re communicating with all your trading partners, all regulatory bodies and their repositories, and your customers. We’ll help keep your lines running smoothly. We’ll yield rich, actionable data that you can use to improve your operations, connect with your customers, and build consumer trust and brand reputation.

We create one uniform, harmonized supply chain that takes care of everything from unit-level serialization and global compliance network needs to closing the last mile all the way to the person buying your product.

Final thoughts

All levels are important. They rely on one another to make things work. When you’re planning a serialization solution, you have to think very carefully about how they’ll interact and communicate.

rfxcel makes sure your data is accurate, travels quickly between and among levels, and meets the requirements of your partners and government authorities — no matter what systems you have in place now or will get in the future. Interconnectivity and interoperability are the cornerstones of all our implementations.

If you have questions about L1-L5, are looking to build a solution, or are considering switching solution providers, contact us today to talk with one of our supply chain experts and see what our award-winning rfxcel Traceability System can do.

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