June 2021 - rfxcel.com
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Dairy Traceability in 2021: The FDA, the Industry, and the Future

It’s June, and it’s definitely ice cream season! It was 96°F (35°C) at our headquarters in Reno, Nevada, yesterday. Naturally, when we think of ice cream, we think about dairy traceability. Dairy traceability ensures consumer safety and keeps vital supply chains moving.

Most of our readers can probably assume that their food was manufactured, processed, transported, and stored safely and in accordance with quality standards and safety regulations. But the World Health Organization estimates that 600 million people are sickened from contaminated food products every year — and as many as 420,000 die. Dairy products are among the biggest culprits, as they can carry pathogens that cause foodborne illnesses.

The implications are significant. And they illustrate why dairy traceability is so important. Let’s take a look at where we are with dairy traceability in 2021.

Dairy traceability: the industry perspective

Dairy traceability has been on the industry’s radar for quite some time. For example, the Innovation Center for U.S. Dairy has been an advocate since at least 2009, when its Globalization Report noted that traceability was, in so many words, the future of the dairy supply chain.

In 2013, the Center published Guidance for Dairy Product Enhanced Traceability. Now in its third iteration (July 2020), it addresses much of what the FDA wants, including establishing and maintaining records with key data elements (KDEs) associated with critical tracking events (CTEs). There’s also a 21-point Dairy Traceability Checklist that manufacturers can use to evaluate if they follow enhanced dairy traceability best practices.

Last, the Center created the U.S. Dairy Traceability Commitment, “designed by processors, for processors, to increase global competitiveness, help satisfy future requirements of the Food Safety Modernization Act (FSMA) and, in the rare event of a safety issue, quickly isolate products to protect public health and prevent brand damage.”

Dairy traceability: the FDA perspective

Traceability — including dairy traceability — and modernization have also been on the FDA’s radar. We’ve written about this before, so we won’t drill down into the details today. In a nutshell:

The new requirements, also known as the Food Traceability Proposed Rule, apply to many popular cheeses, including brie, camembert, feta, mozzarella, Monterey Jack, cottage cheese, ricotta, and queso fresco.

Dairy traceability in 2021

Just about a year after the FDA announced its New Era of Smarter Food Safety Blueprint and the Innovation Center for U.S. Dairy updated its Guidance for Dairy Product Enhanced Traceability, it’s clear the dairy industry and the FDA are trying to get on the same page.

Generally, the industry has been receptive to the FDA’s efforts. The International Dairy Foods Association, for example, supports the New Era of Smarter Food Safety Blueprint. Still, many in the industry say the Food Traceability Proposed Rule isn’t necessary because supply chain stakeholders have been modernizing and building traceability systems without a government mandate.

With that in mind, the International Dairy Foods Association submitted comments to the FDA asking it to revise the recordkeeping requirements, arguing that doing so would support more widespread adoption of dairy traceability across the industry, to the ultimate benefit of the public. The Association is also working with the FDA to ensure dairy manufacturers have the proper direction and tools that support more efficient food safety practices and dairy traceability protocols.

Final thoughts

This quick sketch of dairy traceability makes two things clear. First, the FDA is all-in on modernization and traceability. Second, the industry understands the need for dairy traceability and has shown its willingness to commit to maintaining a modern, traceable supply chain.

In this environment, rfxcel’s traceability solutions will help dairy companies in any market modernize their food safety protocols, facilitate end-to-end traceability in a digital supply chain, comply with evolving regulations, and maintain trust with customers. Contact us for more information about how we can help, and check back soon for more about traceability in the food supply chain.

 

rfxcel DSCSA 2023 Webinar Series: Sneak Peek #3

Our first DSCSA 2023 webinar is today, June 15, at noon Eastern Time! Registration is still open, so sign up now!

For the next three days, our Executive Global Advisor Brian Files, an expert on U.S. and international pharmaceutical compliance, will present key aspects of the DSCSA and answer your questions.

  1. TODAY, JUNE 15: The Verification Router Service: Aligning to the Standard
  2. Wednesday, June 16: ASN to EPCIS: Industry Change, Your Challenge
  3. Thursday, June 17: Authorized Trading Partners: The OCI Solution

We’ve already done sneak peeks about today’s Verification Router Service webinar and Thursday’s presentation about authorized trading partners. Here’s our last sneak peek about “ASN to EPCIS.” Enjoy! And remember to sign up for the series. All registrants can download the webinars starting next week.

What is the DSCSA?

The DSCSA went into effect on November 27, 2013. It calls for product tracing, product identifiers (PIs), authorized trading partners, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies). Full serialization will begin on November 27, 2023.

DSCSA requirements for electronic data exchange

Trading partners must provide transaction information (TI) and a transaction statement (TS) to the subsequent owner of a product “prior to, or at the time of, each transaction.” This information must “be exchanged in a secure, interoperable, electronic manner in accordance with the standards established [through FDA guidance].”

In 2023, TI must include product identifiers (PIs), which include serial numbers and expiration dates. This is part of the full serialization of the U.S. pharmaceutical supply chain.

The FDA puts a premium on these requirements, saying, “electronic, interoperable exchange of TI is … foundational to achieving electronic interoperable tracing and verification … .”

What is ASN?

An advanced shipping notice (ASN) tells what’s being shipped (e.g., number of items, shipment date, number of boxes, shipment weight, description of packaging) and how it’s being shipped (e.g., land, sea, air).

Why are people talking about ASN? Because it does not currently support DSCSA 2023 requirements for including PIs. What are the ramifications?

What is EPCIS?

The Electronic Product Code Information Service (EPCIS) is a global GS1 standard for exchanging Electronic Product Code (EPC) information and enables automatic communication and exchange of authenticated data.

Right now, it seems to be the pharma industry’s preference for meeting DSCSA requirements — but will it remain the frontrunner, or will another standard gain favor?

Final thoughts

Again, head over to our registration page so you can join Brian today, tomorrow, and Thursday. All the webinars begin at noon Eastern Time and will last up to 45 minutes (depending on how long our Q&A goes).

See you at the webinars!

DSCSA 2023 Webinar_June 15-17

 

rfxcel DSCSA 2023 Webinar Series: Sneak Peek #2

Full serialization of the U.S. pharmaceutical supply chain is coming on November 27, 2023. To help make sure you have the latest information and are doing everything you can to be prepared, we’re hosting the rfxcel DSCSA 2023 webinar series on June 15, 16, and 17.

Our Executive Global Advisor Brian Files, an expert on U.S. and international pharmaceutical compliance, will present three key aspects of the DSCSA and answer your questions. Sign up today!

  1. Tuesday, June 15: The Verification Router Service: Aligning to the Standard
  2. Wednesday, June 16: ASN to EPCIS: Industry Change, Your Challenge
  3. Thursday, June 17: Authorized Trading Partners: The OCI Solution

Here’s a sneak peek about DSCSA authorized trading partners (ATPs). Check back for one last sneak peek before Brian kicks off the webinars on June 15!

What is the DSCSA?

The DSCSA went into effect on November 27, 2013. In addition to ATPs, it calls for product tracing, product identifiers (PIs), and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies). As we said above, full serialization is scheduled to begin on November 27, 2023.

What are ATPs?

Under the DSCSA, manufacturers, wholesale distributors, repackagers, third-party logistics providers (3PLs), and dispensers are ATPs. They may engage in transactions only with other ATPs.

In other words, these supply chain actors and their trading partners must be ATPs. (In broad terms, a trading partner is an entity that accepts or transfers direct ownership of a product from or to a manufacturer, repackager, wholesale distributor, or dispenser.) If you are not an ATP, your access to the U.S. pharma supply chain will be severely restricted or denied altogether.

ATP requirements at a glance

To be considered an ATP,  manufacturers, wholesale distributors, repackagers, 3PLs, and dispensers must meet the criteria presented in the table below, which we’ve adapted from an August 2017 FDA publication.

ATP Requirements

Final thoughts

Be sure to join us on June 15, 16, and 17 for our DSCSA 2023 webinar series. Register today and submit your questions for Brian. You can also contact us to talk with one of our supply chain experts and see how our award-winning rfxcel Traceability System can ensure you comply with all DSCSA requirements.

See you on June 15!

DSCSA 2023 Webinar_June 15-17

Vinicius Bagnarolli with rfxcel Corporation Accepted into Forbes Business Development Council

Forbes Business Development Council Is an Invitation-Only Community for Senior-Level Sales and Business Development Executives

Reno, Nevada, June 10, 2021 (EINPRESSWIRE). Vinicius Bagnarolli, director of Latin American operations for rfxcel Corporation, part of Antares Vision Group and a global leader in digital supply chain traceability solutions, has been accepted into Forbes Business Development Council, an invitation-only community for senior-level sales and business development executives.

Mr. Bagnarolli was vetted and selected by a review committee based on the depth and diversity of his experience. Criteria for acceptance include a track record of successfully impacting business growth metrics, as well as personal and professional achievements and honors.

“We are honored to welcome Vinicius Bagnarolli into the community,” said Scott Gerber, founder of Forbes Councils, the collective that includes Forbes Business Development Council. “Our mission with Forbes Councils is to bring together proven leaders from every industry, creating a curated, social capital-driven network that helps every member grow professionally and make an even greater impact on the business world.”

As an accepted member of the Council, Mr. Bagnarolli has access to a variety of exclusive opportunities designed to help him reach peak professional influence. He will connect and collaborate with other respected local leaders in a private forum. He will also be invited to work with a professional editorial team to share his expert insights in original business articles on Forbes.com, and to contribute to published Q&A panels alongside other experts.

“I’m beyond excited to have been accepted by this prestigious group of leaders,” said Mr. Bagnarolli. “This re-enforces my personal commitment — and Antares Vision Group’s and rfxcel’s commitment — to always bringing new technologies, approaches, and industry wisdom to our customers and partners. Being part of the Forbes Business Development Council will definitely strengthen our position as a global leader in digital supply chain solutions.”

Mr. Bagnarolli added that he looked forward to sharing how Antares Vision Group’s complete track and trace solution and rfxcel’s signature Traceability System (rTS) help customers accelerate their transition toward digital and sustainable supply chains characterized by full transparency and visibility. “I not only want to learn from other members of the Forbes Business Development Council; I want to let them know about how we’re improving business operations for our customers.”

ABOUT FORBES COUNCILS

Forbes Councils is a collective of invitation-only communities created in partnership with Forbes and the expert community builders who founded Young Entrepreneur Council (YEC). In Forbes Councils, exceptional business owners and leaders come together with the people and resources that can help them thrive.

For more information about Forbes Business Development Council, visit forbesbizdevcouncil.com. To learn more about Forbes Councils, visit forbescouncils.com.

ABOUT RFXCEL

rfxcel, part of Antares Vision Group, 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. Founded in 2003, 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 GROUP

Listed since April 2019 on the Italian Stock Exchange in the AIM Market, the Antares Vision Group guarantees protection of products, people and brands through inspection systems for quality control, Track & Trace solutions for anti-counterfeiting and supply chain transparency, smart data management tools for maximized efficiency and digitalization of the supply chain, from raw materials to the final consumer. The Antares Vision Group is active in the pharmaceutical market and in Life Science in general (biomedical devices and hospitals), in beverage, food, cosmetic and in consumer-packaged goods. The Group reaches over 60 countries in the World with complete and flexible solutions, hardware, and software, with related services and counts 7 Italian sites (Brescia, Parma, Piacenza, Latina, Collecchio, Mestrino e Vicenza), 22 company sites worldwide (Germany, France [3], USA [7], Latin America [2], UK, Spain, South Korea, India, Russia, Hong Kong, China, Croatia and Serbia), 3 Innovation and Research Centers (Italy) and a worldwide network of more than 40 partners. Thanks to the twenty years of experience in vision technologies of the two founding partners, the Antares Vision Group is the supplier of 10 out of 20 leading pharmaceutical companies in the world, with more than 25.000 inspection systems, that ensure everyday product safety and quality, 6.500 quality controls and more than 3.500 serialization modules on lines installed all over the. With the aim of continuing and supporting the growth and development strategy, during 2019 participation agreements were finalized with T2 Software, a Brazilian company specialized in smart data management solutions, and Orobix, an Italian company leader in artificial intelligence services, as well as the acquisition of 100% of FT System, leader in control and inspection in the beverage sector. In 2020, Antares Vision acquired 82.83% of Tradeticity, a Croatian company specialized in software management of traceability and serialization processes, 100% 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, 100% of Applied Vision, a global leader in inspection systems for glass and metal containers in food & beverage. In March 2021, Antares Vision acquired 100% of rfXcel Corporation, specialized in software solutions for digitalization and supply chain transparency based in the U.S., and 100% of Pen-Tec and Tecnel, through FT System, increasing specialization in Food & Beverage inspection sector. In 2019 Emidio Zorzella and Massimo Bonardi won the Ernst & Young “Entrepreneur of the Year” award for innovation.

FOR FURTHER INFORMATION:

Antares Vision PR Specialist

Davide Antonioli, davide.antonioli@antaresvision.com | M. +39 339 8124446

rfxcel Vice President of Marketing and Strategic Initiatives

Herb Wong, hwong@rfxcel.com | 925-791-3235

 

rfxcel, Part of Antares Vision Group, and MVC Launch the Traceability Hub for the Kingdom of Bahrain to Track End-to-End Pharma Supply Chain

Travagliato (Brescia), June 3, 2021 (MarketScreener). Antares Vision Group, the international leader in the pharmaceutical sector for track and trace hardware and software solutions (anti-counterfeiting and supply chain transparency), with an established presence in inspection systems (quality control), and active in smart data management (production efficiency and end-to-end supply chain digitalization, from raw materials to the final consumer), announced today that its subsidiary rfxcel has successfully implemented an end-to-end Traceability Hub to monitor and secure the Kingdom of Bahrain’s global pharmaceutical supply chain process. The initial value of this contract is approximately 4-6 percent of Antares Vision FY 2020 pro-forma revenues.

Bahrain’s National Health Regulatory Authority (NHRA) and Supreme Council of Health selected Medical Value Chain (MVC) and its partner rfxcel to provide the first GS1-compliant system to track its entire pharmaceutical supply chain on a blockchain platform. The end-to-end Traceability Hub delivers complete visibility into every node of the Kingdom’s supply chain, from the manufacturer of origin, importers, wholesalers, and distributors to pharmacies, clinics, and hospitals — all the way to individual patients.

The objective of the NHRA Bahrain Traceability Hub is to achieve following:

  • End-to-end traceability for all medicine imports to Bahrain
  • Bahrain pharma supply chain to meet the global track and trace requirements and GS1 standards
  • Complete visibility and repository of medicine inventory and supply-chain info from manufacturers to agents/importers to wholesalers/distributors to pharmacies/hospitals and to patients/consumers
  • Increase patient safety
  • Detect and stop counterfeit medicines
  • Analytics of medicine imports and consumption in Bahrain
  • Manage product recalls and shortages efficiently and quickly

Glenn Abood, rfxcel CEO, said, “The end-to-end Traceability Hub offers an array of other benefits for all pharmaceutical supply chain stakeholders. The Hub is the first of its kind in the Gulf Cooperation Council. It creates a single source of truth for all medications, which means improved patient safety, better flow of information, and more accurate inventory management. It is also a powerful tool to prevent counterfeit and substandard drugs from reaching the market.”

Emidio Zorzella, Antares Vision Group CEO, said, “I am honored that the Kingdom of Bahrain chose Antares Vision Group in partnership with MVC to secure and optimize its pharma supply chain. In the near future, we expect to announce national traceability hubs in other countries to track pharmaceutical, agricultural, and consumer products.”

MVC President Leo Giacometto said, “When we set up our company to provide a blockchain-enabled track and trace platform to provide customs clearances and supply chain financing, we needed the absolute best track and trace solution and most experienced team in the market; that is rfxcel, now part of Antares Vision Group!”

ABOUT RFXCEL

Part of Antares Vision Group, 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. Founded in 2003, 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 GROUP

Listed since April 2019 on the Italian Stock Exchange in the AIM Market, and from 14 May 2021 on Mercato Telematico Azionario (MTA) STAR segment, the Antares Vision Group guarantees protection of products, people and brands through inspection systems for quality control, Track & Trace solutions for anti-counterfeiting and supply chain transparency, smart data management tools for maximized efficiency and digitalization of the supply chain, from raw materials to the final consumer. The Antares Vision Group is active in the pharmaceutical market and in Life Science in general (biomedical devices and hospitals), in beverage, food, cosmetic and in consumer-packaged goods. The Group reaches over 60 countries in the World with complete and flexible solutions, hardware, and software, with related services and counts 7 production facilities in Italy (Brescia, Parma, Piacenza, Latina, Padua and Vicenza), 22 foreign subsidiaries (Germany [2], France [2], USA [5], Brazil [2], United Kingdom [2], India, Russia [3], Hong Kong, China, Ireland, Croatia and Serbia), 3 Innovation and Research Centers (Italy) and a worldwide network of more than 40 partners. Thanks to the twenty years of experience in vision technologies of the two founding partners, the Antares Vision Group is the supplier of 10 out of 20 leading pharmaceutical companies in the world, with more than 25.000 inspection systems, that ensure everyday product safety and quality, 6.500 quality controls and more than 3.500 serialization modules on lines installed all over the. With the aim of continuing and supporting the growth and development strategy, during 2019 participation agreements were finalized with T2 Software, a Brazilian company specialized in smart data management solutions, and Orobix, an Italian company leader in artificial intelligence services, as well as the acquisition of 100% of FT System, leader in control and inspection in the beverage sector. In 2020, Antares Vision acquired 82.83% of Tradeticity, a Croatian company specialized in software management of traceability and serialization processes, 100% 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, 100% of Applied Vision, a global leader in inspection systems for glass and metal containers in food beverage. In March 2021, Antares Vision acquired 100% of rfxcel Corporation, specialized in software solutions for digitalization and supply chain transparency based in the U.S., and 100% of Pen-Tec and Tecnel, through FT System, increasing specialization in Food & Beverage inspection sector. In 2019 Emidio Zorzella and Massimo Bonardi won the Ernst & Young “Entrepreneur of the Year” award for innovation.

For further information:

ANTARES VISION S.P.A.

Via Del Ferro, N. 16

25039 – Travagliato (BS)

Alessandro Baj Badino, Investor Relator

Tel.: +39 030 72 83 500

E-mail: Investors@antaresvision.com

RFXCEL

Herb Wong, Vice President of Marketing and Strategic Initiatives

Tel.: +1 925-791-3235

E-mail: hwong@rfxcel.com

IR ADVISOR

IR Top Consulting

Via Bigli, N. 19

20121 – Milano

Tel.: +39 02 45473884

Maria Antonietta Pireddu: m.pireddu@irtop.com

Antonio Buozzi: a.buozzi@irtop.com

 

 

rfxcel to Integrate Spherity Credentialing Service into Its VRS Solution for DSCSA Authorized Trading Partner Compliance

Beginning in June, rfxcel customers can use the service to confirm their authorized trading partner status in saleable return verifications.

Reno, Nevada, June 3, 2021 (EINPRSSWIRE). rfxcel, part of Antares Vision Group and a global leader in digital supply chain traceability solutions, today announced it would integrate the Spherity Credentialing Service into its Verification Router Service (VRS) solution, enabling companies to verify their authorized trading partner (ATP) status per requirements in the U.S. Drug Supply Chain Security Act (DSCSA).

rfxcel customers can begin using the service in June. As mandated by the DSCSA, only ATPs will be permitted to exchange information in the U.S. pharmaceutical supply chain starting on November 27, 2023.

The Spherity Credentialing Service uses blockchain technology to establish a secure, verifiable digital enterprise identity for every ATP. By integrating the service into its VRS solution, rfxcel customers can ensure secure, authenticated data exchange with other ATPs and verify they have the credentials required by the DSCSA, including state licenses and U.S. Food and Drug Administration Entity Identifiers (FEIs).

Herb Wong, vice president of marketing and strategic initiatives at rfxcel, said the partnership builds on the relationship built with Spherity in the Open Credentialing Initiative (OCI), a user group comprising industry stakeholders working on rolling out, standardizing, and exploring credential-based implementations in the pharmaceutical supply chain.

“rfxcel is excited to partner with Spherity to ensure the integrity of both the physical and digital supply chain,” he said. “The Spherity Credentialing Service is the most comprehensive effort to address the upcoming ATP requirement for DSCSA and is a good match with our industry-leading VRS solution. Spherity’s leadership in the OCI was impressive, and rfxcel looks forward to offering our customers these complementary solutions this summer.”

Spherity CEO Dr. Carsten Stöcker said, “rfxcel, as an innovation pioneer in the industry, and Spherity have been a good fit from the very beginning, since the start of the collaboration. We are now very proud that rfxcel is offering our new Spherity Credentialing Service to their customers and look forward to delivering further integrations to establish trust in supply chains.”

For more information about the rfxcel-Spherity partnership, rfxcel’s solutions for DSCSA compliance, including the VRS, and the OCI, contact Vice President of Marketing and Strategic Initiatives Herb Wong at hwong@rfxcel.com and visit rfxcel.com, or Antares Vision PR Specialist Davide Antonioli at davide.antonioli@antaresvision.com and visit AntaresVision.com.

ABOUT RFXCEL

Part of Antares Vision Group, 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. Founded in 2003, 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 SPHERITY

Spherity is building decentralized digital identity management solutions to power the fourth industrial revolution, bringing secure identities to enterprises, machines, products, data and even algorithms. We provide the enabling technology to digitize and automate compliance processes primarily on highly-regulated technical sectors like pharmaceuticals, automotive and logistics. Spherity’s decentralized cloud identity wallet empowers cyber security, efficiency and data interoperability among digital value chains. Spherity is certified according to the information security standard ISO 27001.

ABOUT ANTARES VISION GROUP

Listed since April 2019 on the Italian Stock Exchange in the AIM Market, the Antares Vision Group guarantees protection of products, people and brands through inspection systems for quality control, Track & Trace solutions for anti-counterfeiting and supply chain transparency, smart data management tools for maximized efficiency and digitalization of the supply chain, from raw materials to the final consumer. The Antares Vision Group is active in the pharmaceutical market and in Life Science in general (biomedical devices and hospitals), in beverage, food, cosmetic and in consumer-packaged goods. The Group reaches over 60 countries in the World with complete and flexible solutions, hardware, and software, with related services and counts 7 Italian sites (Brescia, Parma, Piacenza, Latina, Collecchio, Mestrino e Vicenza), 22 company sites worldwide (Germany, France [3], USA [7], Latin America [2], UK, Spain, South Korea, India, Russia, Hong Kong, China, Croatia and Serbia), 3 Innovation and Research Centers (Italy) and a worldwide network of more than 40 partners. Thanks to the twenty years of experience in vision technologies of the two founding partners, the Antares Vision Group is the supplier of 10 out of 20 leading pharmaceutical companies in the world, with more than 25.000 inspection systems, that ensure everyday product safety and quality, 6.500 quality controls and more than 3.500 serialization modules on lines installed all over the. With the aim of continuing and supporting the growth and development strategy, during 2019 participation agreements were finalized with T2 Software, a Brazilian company specialized in smart data management solutions, and Orobix, an Italian company leader in artificial intelligence services, as well as the acquisition of 100% of FT System, leader in control and inspection in the beverage sector. In 2020, Antares Vision acquired 82.83% of Tradeticity, a Croatian company specialized in software management of traceability and serialization processes, 100% 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, 100% of Applied Vision, a global leader in inspection systems for glass and metal containers in food & beverage. In March 2021, Antares Vision acquired 100% of rfxcel Corporation, specialized in software solutions for digitalization and supply chain transparency based in the U.S., and 100% of Pen-Tec and Tecnel, through FT System, increasing specialization in Food & Beverage inspection sector. In 2019 Emidio Zorzella and Massimo Bonardi won the Ernst & Young “Entrepreneur of the Year” award for innovation.

FOR FURTHER INFORMATION

Antares Vision PR Specialist

Davide Antonioli, davide.antonioli@antaresvision.com | M. +39 339 8124446

rfxcel Vice President of Marketing and Strategic Initiatives

Herb Wong, hwong@rfxcel.com | 925-791-3235

rfxcel DSCSA 2023 Webinar Series: Sneak Peek #1

Full serialization of the U.S. pharmaceutical supply chain is coming in November 2023. That may seem like a long way off, but time flies and it will be here before you know it. To help make sure you’re working toward that deadline and doing everything you can to be prepared, we’re hosting the rfxcel DSCSA 2023 webinar series on June 15, 16, and 17.

Our Executive Global Advisor Brian Files, an expert on U.S. and international pharmaceutical compliance, will present three key aspects of the DSCSA and answer your questions. Sign up today!

  1. Tuesday, June 15: The Verification Router Service: Aligning to the Standard
  2. Wednesday, June 16: ASN to EPCIS: Industry Change, Your Challenge
  3. Thursday, June 17: Authorized Trading Partners: The OCI Solution

Here’s a sneak peek about the DSCSA Verification Router Service (VRS). Check back for more sneak peeks leading up to Brian’s other presentations in our rfxcel DSCSA 2023 webinar series!

What is the DSCSA?

The DSCSA went into effect on November 27, 2013. It calls for product tracing, product identifiers (PIs), authorized trading partners, and verification requirements for manufacturers, wholesale distributors, repackagers, and dispensers (pharmacies). As we said above, full serialization will begin in November 2023 (the 27th, to be exact).

What is the DSCSA saleable returns verification requirement?

Under the DSCSA saleable returns verification requirement, wholesalers must verify saleable returns before they can be reintroduced to the supply chain. This is done by verifying the drug’s PI, which comprises a Standardized Numerical Identifier (National Drug Code and a unique alphanumeric serial number), a lot ID, and an expiration date.

How does the DSCSA saleable returns requirement work?

A wholesaler must initiate a verification request (to a manufacturer) to verify the returned products. The manufacturer must provide a verification response within 24 hours. Wholesalers are called requestors and manufacturers are called responders.

The VRS and the DSCSA saleable returns verification requirement

The VRS enables the rapid, secure exchange of data between requestors and responders to meet the DSCSA saleable returns verification requirement. It’s an automated service that verifies if a PI is valid. A solution provider enables the verification requests to be routed between wholesalers and manufacturers.

Final thoughts

Be sure to join Brian on June 15 for “The Verification Router Service: Aligning to the Standard,” the first in our rfxcel DSCSA 2023 webinar series. Register today and submit your questions for Brian. You can also contact us to talk with one of our supply chain experts and see how our award-winning rfxcel Traceability System can ensure you comply with the saleable returns verification requirement and other key DSCSA requirements.

See you on June 15!

DSCSA 2023 Webinar_June 15-17