October 2019 - rfxcel.com
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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!

How Asian Pharma Companies Can Comply with Russia’s New Serialization Requirements

Pharmaceutical companies in India, China, and Asia-Pacific Economic Cooperation (APEC) countries are already complying with serialization and traceability laws that mandate serialization and traceability. Most notable are the U.S. Drug Supply Chain Security Act (DSCSA) and the EU’s Falsified Medicines Directive (FMD).

Soon, however, Asian companies that want to do business in Russia will have to comply with that country’s new serialization requirements, which will be the most comprehensive in the world. The complex regulations go into effect on January 1, 2020, so companies that have not begun preparing need to start now.

To be compliant by the deadline, Asian pharma companies must do three things: assemble a dedicated project team, design and conduct a pilot phase, and find a trustworthy technology partner to help navigate the process.

Assemble a Dedicated Team

The road to compliance can be demanding, so it’s essential to have a dedicated team in place to maintain momentum and keep your plans on track.

Your team should be led by a project manager who is well-versed in the Russian regulatory landscape. They should also be skilled in appointing and managing a team that understands the importance of serialization. Your project team must have a comprehensive understanding of drug supply chains, including where ownership is passed from one party to another.

You must also have a clear vision of your IT landscape and data flow, and assign team members to be responsible for these facets of the process.

Design and Conduct a Pilot Phase

Conducting a pilot is crucial to make sure formal implementation goes smoothly. A pilot can uncover potential setbacks and provides a chance to discuss the functional requirements of being compliant. Importantly, Asian companies must ensure they have all the necessary equipment for labeling. For example, look at the needs for Data Matrix Codes and Electronic Data Interchange (EDI) labels, and assess if you’ll need an Electronic Document Management System (EDMS).

To launch a pilot phase properly, it’s also vital to have the right scanning equipment, cash software, and accounting systems, as well as a sophisticated IT solution. You should review what type of cash register and related software you’re using and verify how — and if — it will work with Russia’s new marking requirements.

Find the Right Technology Partner

When deciding on a technology partner to help meet regulation deadlines, be sure to choose one that has your best interests in mind. They must also be willing to work collaboratively to ensure flexibility to meet the final details of the Russia regulations, which have yet to be announced.

Your partner should be an experienced service provider that can adhere to tight timeframes, keep you in the loop about changing global regulations, and work with you to customize solutions that adapt to changes in the industry. Proactive, two-way communication is also a priority, and technical jargon should be kept to a minimum. It’s also important that your technology partner is committed to cybersecurity and data management, as you will be sharing large amounts of data.

Some Asian pharma companies may think it will be difficult to be ready for Russia’s serialization requirements (or any new pharma regulations). However, it’s a worthwhile investment in time and resources.

Russia’s pharmaceutical market is expected to reach $38 billion by 2021. Not complying with the new regulations would be disastrous for any Asian company’s bottom line, as they would be denied access to this lucrative market.

If you haven’t begun, there’s still time to be ready by January 2020. But you need to act now. Start by building your team, planning a pilot, and finding your technology partner. rfxcel can help you take the first critical steps. We have an experienced team in Russia, so contact us today to get started!

rfxcel to Speak at Pharma Logistics Conference in Sao Paulo

Sao Paulo, Brazil, Oct. 21, 2019. Vinicius Bagnarolli, rfxcel’s director of operations for Latin America, will speak about serialization best practices, preparing for Brazil’s National Medicine Control System (SNCM), and Supply Chain 4.0 at the Enterprise Business Development and Information (ebdi) Pharma Logistics & Cold Chain 2019 Conference October 23-24 in Sao Paulo.

rfxcel, the leader in digital traceability solutions for the pharmaceutical industry, has prioritized helping Brazilian companies prepare for SNCM, a medicine traceability system designed to establish mechanisms and procedures for tracking and tracing drugs in Brazil. The Brazilian Health Regulatory Agency (ANVISA) has been working on the regulations since 2009; they are scheduled to take effect in May 2022.

The conference, titled “Innovation and Regulation Together for the Growth of the Pharmaceutical Ecosystem,” will be held at Sau Paulo’s Villa Bisutti Casa do Ator hotel. It will feature panel discussions, lectures, plenary sessions, and networking events. Over two days, attendees will learn about regulatory affairs, how and where to invest in supply chain logistics technology, process management and integration, and experts’ predictions for Brazil’s supply chain.

Bagnarolli will speak on Day 1, stressing the importance of following supply chain best practices to prepare for SNCM, which requires unit-level serialization, tracking/tracing and monitoring products environmental conditions, and submitting detailed transaction data to the government. He will also review the processes, technologies, and machinery that will help companies be ready for the future, including Supply Chain 4.0 and blockchain. Discussing the benefits of track and trace solutions, he will highlight rfxcel’s industry-leading technology, including our signature rfxcel Traceability Solution (rTS) platform and rfxcel Integrated Monitoring (rIM), which can track more than a dozen environmental factors in real time.

“I’m happy to have the opportunity to speak directly to the industry,” Bagnarolli said. “SNCM is 30 months away; this may seem like a long time, but companies have to act now to be ready to comply. I want people to know the value track and trace technology brings to the supply chain, and what other steps they can take to add value to their operations. The changes may seem complex, but implementing best practices now will ensure you’re ready for the future — for SNCM, Supply Chain 4.0, blockchain, artificial intelligence, and beyond — and can bring immediate value to your bottom line.”

Bagnarolli, who grew up in Porto Alegre, added, “I really want to emphasize that Brazil must embrace Supply Chain 4.0 now. rfxcel is ready to provide guidance on how to best approach the changes that are coming. The unique software capabilities we have developed over the past 15 years have helped companies around the world meet stringent compliance requirements, safeguard their supply chains, and expand their markets. I’m looking forward to talking about best practices, how to prepare for SNCM, and the future of our supply chain.”

To learn more about rfxcel’s innovative track and trace products, contact Vice President of Marketing Herb Wong or visit rfxcel.com.

Herb Wong, VP of Marketing

hwong@rfxcel.com

925-824-0300

 

About rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. The company is headquartered in the United States and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

rfxcel to Exhibit, Discuss DSCSA VRS at HDA Seminar in D.C.

rfxcel, the global leader in supply chain track and trace solutions and the pharma industry’s thought leader in the Verification Router Service (VRS), will exhibit at the Healthcare Distribution Alliance’s (HDA’s) 2019 Traceability Seminar October 21-23 at the Marriott Wardman Park Hotel in Washington, D.C.

The HDA is a sponsor of the seminar, an annual event that brings together healthcare supply chain leaders to learn more about implementation milestones of the Drug Supply Chain Security Act (DSCSA) — as well as innovative approaches and lessons learned — as distributors, manufacturers, and dispensers implement serialization and traceability technologies to further preserve the safety and security of the healthcare supply chain.

This year’s gathering occurs less than a month after the U.S. Food and Drug Administration (FDA) announced that it did “not intend to take action against wholesale distributors” that do not meet the DSCSA Saleable Returns Verification Requirement before November 27, 2020. This is a 1-year extension of the original deadline for wholesale distributors to verify a product identifier before further distributing a returned product.

rfxcel is leading an FDA pilot to measure VRS readiness, and is looking forward to hosting a discussion about the state of the VRS and the effects of the FDA’s deadline extension. The company will share the interim pilot report it has prepared for the FDA, which presents findings of the tests it has conducted across the VRS network of providers.

Herb Wong, rfxcel’s executive sponsor of the FDA VRS pilot, said, “We’re excited to talk about VRS and share the findings of our pilot. We also want to talk about the deadline extension, which we believe is the right decision because it will allow the industry to test more production-like scenarios. When you’re at the Traceability Seminar, visit our team at Booth 9 to talk about all the latest developments. No matter what, companies should continue with their planned VRS implementation efforts so they’ll benefit from the continued testing.”

rfxcel began its FDA-approved VRS pilot in June. It is designed to quantify the readiness of the VRS network to meet the DSCSA’s Saleable Returns Verification Requirement. The pilot builds on the HDA’s VRS efforts and will systematically verify, measure, and report on the ability of the VRS network to meet the functional requirements of VRS.

A key and unique aspect of the pilot is that rfxcel has been sharing the details of its VRS test cases with all VRS providers to ensure they have a common detailed set of test cases. rfxcel will continue to work with the providers to verify the test conditions to enable maximum readiness of the VRS network across all VRS providers.

rfxcel CEO Glenn Abood said the company was honored to participate in the HDA seminar and would be prepared to field questions. “We’re the longest-tenured track and trace solution provider in the pharma industry and the thought leader in VRS,” he said. “We’re ready to share our expertise and discuss our VRS pilot to measure and ensure the seamless interoperability between VRS providers across a broad range of use cases. Recent developments don’t change the fact that complete and consistent verification of the use cases is critical to successfully meeting the DSCSA Saleable Returns Verification Requirement. Companies should remain on course and use the extra time to ensure they’re ready for 2020.”

To learn more about rfxcel’s FDA VRS pilot, its VRS solution, and other innovative track and trace products, visit the company at Booth 9, contact Herb Wong directly, or book a meeting at rfxcel.com.

 

Herb Wong, VP of Marketing

hwong@rfxcel.com

925-824-0300

 

About rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. The company is headquartered in the United States and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

rfxcel to Demo Track & Trace Tech at PMA Fresh Summit

October 9, 2019. Members of rfxcel’s Food and Beverage Team will be at the PMA Fresh Summit 2019 to talk about the changing landscape of food production, distribution, and marketing, and how companies that harness supply chain data will win the future.

The team will showcase rfxcel’s latest track and trace innovations, including its signature rfxcel Traceability System (rTS), an improved rfxcel MobileTraceability app, and the rfxcel Integrated Monitoring (rIM) solution. These products work together to yield real-time validated data at the unit, case, pallet, and lot levels. They harness mobile technology and the Internet of Things (IoT) for the most complete view of your production while ensuring you are always compliant with regulators and your customers.

“We have always enjoyed the PMA Fresh Summit 2019,” said rfxcel CEO Glenn Abood. “This year, we’re focusing on the power and importance of data, and we’re especially excited because we’ll be showing technology that’s tailor-made for the food and beverage industry. For example, our rIM solution yields an array of rich data, from cut-to-cool time to in-transit conditions on land, sea, and air. And our rfxcel MobileTraceability app enables any user to execute full supply chain visibility from the palm of their hand and from any location.”

rfxcel’s MobileTraceability app captures and reports data when and where it happens. Currently available for Android devices and most handheld mobile scanners, it lets users see everything, everywhere — in the field, at the dock, on the production floor. It can create new events such as quality inspection results so users can capture non-traditional traceability data or create/track the workflow that best suits their business needs. Expect an iOS version in the near future.

The Food and Beverage Team will be running a live demo of rfxcel’s powerful rIM solution. Using IoT-enabled sensors and the power of rTS, rIM captures critical data about more than a dozen environmental conditions (e.g., temperature, humidity, light, tilt) and sends real-time updates for 24/7 monitoring of perishable goods. rIM is more than cold-chain monitoring: It’s a sensor-agnostic solution that can be configured to solve the unique challenges of any supply chain.

Attendees can also request a demo of the rTS platform, which has been proven in the strict regulatory environment of the pharmaceutical industry, where bad data can threaten more than business — it can threaten lives. rTS features a best-in-class serialization solution and can track units, cases, pallets, and lots. The demo will show how rTS tracks all raw material lots as they travel from different farms to a central processing facility and are transformed into a new product for distribution.

“It’s an exciting time at rfxcel,” Abood said. “Our data capabilities are exciting; there is so much technology coming to food supply chains as companies realize the value of visibility. We unify all of those initiatives into a single platform. Be sure to stop by Booth 4829 to see what we can do.”

To learn more about rfxcel’s MobileTraceability app, rIM, rTS, and the company’s other innovative track and trace solutions, see us at the PMA Fresh Summit 2019 on October 17-19, contact Herb Wong, or visit rfxcel.com.

Herb Wong, VP of Marketing

hwong@rfxcel.com

925-824-0300

 

About rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. The company is headquartered in the United States and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

Join rfxcel at the PMA Fresh Summit Convention + Expo!

rfxcel’s Food and Beverage team will be the PMA Fresh Summit October 17-19 at the Anaheim Convention Center in Anaheim, California. Visit us at Booth 4829 to talk about the changing landscape of food production, distribution, and marketing, and how companies that harness supply chain data will win the future.

We’ll be exhibiting our latest track and trace innovations, including our signature Traceability System (rTS), an improved MobileTraceability app, and our Integrated Monitoring (rIM) solution. These products work together to yield real-time validated data at the unit, case, pallet, and lot levels. They harness mobile technology and the Internet of Things (IoT) for the most complete view of your production while ensuring you are always compliant with regulators and your customers.

We’re All About the Data

This year, we’re focusing on the power and importance of data. We’ll be showcasing data-centric technology that’s tailor-made for the food and beverage industry. For example, we’ll be running a live demo of rIM, so stop by and see everything it can do. Here’s a teaser:

  • It yields an array of super-rich data, from cut-to-cool time to in-transit conditions on land, sea, and air.
  • It uses IoT-enabled sensors and the power of rTS to capture critical data about more than a dozen environmental conditions.
  • It sends real-time updates for 24/7 monitoring of perishable goods.
  • It’s more than cold-chain monitoring: It’s a sensor-agnostic solution that can be configured to solve the unique challenges of any supply chain.

You can also request a demo of our rTS platform, which features a best-in-class serialization solution and can track units, cases, pallets, and lots. You’ll see how it tracks all raw material lots as they travel from different farms to a central processing facility where they’re transformed into a new product for distribution.

Furthermore, rTS has proven itself time and again in the strict regulatory environment of the pharmaceutical industry, where there’s simply no room for bad data. We want to show you exactly what it can do for your food and beverage operations.

Going Mobile: Manage Your Supply Chain and Engage Consumers with Data

We’re excited to bring our MobileTraceability app to this year’s Fresh Summit! Powered by rTS, it captures and reports on data when and where it happens. Available for Android devices and most handheld mobile scanners, it lets users see everything, everywhere — in the field, at the dock, on the production floor. It can create new events such as quality inspection results so users can capture non-traditional traceability data or create/track the workflow that best suits their business needs.

Beyond that, MobileTraceability lets you connect with consumers at the critical moment of purchase. As you know, consumers buy on attributes. They demand to know where their products come from. They want to know their food is safe to eat and authentic. Plus, they have an almost unlimited number of choices.

The MobileTraceability app communicates value to consumers. It makes your products stand out from the crowd. Using its rich, actionable data, you can:

  • Build consumer trust by empowering them to validate the authenticity and provenance of your products
  • Deliver product insights that capitalize on shoppers’ increasing scanning habits
  • Deliver the data and attributes that matter to your consumers, including expiry date, temperature data for a product’s lifecycle, harvest date, and grower certifications
  • Incentivize feedback through individual rewards enabled through rfxcel’s serialization solution
  • Drive engagement, brand development, and feedback into production
  • Build brand loyalty and increase wallet share in a 1:1, cost-effective, and dynamic manner

So, Are You Ready?

Are you ready to drive new growth using powerful data from rfxcel technology? Do you want to optimize your track and trace capabilities? What about realizing 1:1 consumer engagement?

We’ll be at the PMA Fresh Summit all three days, from October 17 to 19. We want to meet with you. Come by Booth 4829 or contact us today to book an appointment.

See you in Anaheim!

 

 

Join rfxcel at the HDA 2019 Traceability Seminar!

rfxcel will be at the Healthcare Distribution Alliance’s (HDA’s) 2019 Traceability Seminar October 21-23 at the Marriott Wardman Park Hotel in Washington, D.C. Stop by Booth 9 to meet our team and learn the latest from the industry’s leader in supply chain track and trace solutions!

The annual Traceability Seminar brings together healthcare supply chain leaders to learn more about implementation milestones of the Drug Supply Chain Security Act (DSCSA) — as well as innovative approaches and lessons learned — as distributors, manufacturers, and dispensers implement serialization and traceability technologies to further preserve the safety and security of the healthcare supply chain.

Get the Latest News about the DSCSA VRS

We’re looking forward to hosting a discussion about the state of the Verification Router Service (VRS)!

As you probably know, rfxcel is leading the U.S. Food and Drug Administration’s (FDA’s) pilot to measure readiness for the VRS. We’ll share the interim pilot report we’ve prepared for the FDA, which presents findings of the tests we’ve conducted across the VRS network of providers.

We began our VRS pilot in June. It’s designed to quantify the readiness of the VRS network to meet the DSCSA’s Saleable Returns Verification Requirement. The pilot builds on the HDA’s VRS efforts and will systematically verify, measure, and report on the ability of the VRS network to meet the functional requirements of VRS.

A key and unique aspect of the pilot is that we have been sharing the details of our VRS test cases with all VRS providers to ensure they have a common detailed set of test cases. We’ll continue to work with the providers to verify the test conditions to enable maximum readiness of the VRS network across all VRS providers.

Hear What the Extension of the DSCSA Saleable Returns Verification Requirement Means for Your Business

This year’s Traceability Seminar comes less than a month after the FDA announced that it did “not intend to take action against wholesale distributors” that do not meet the DSCSA Saleable Returns Verification Requirement before November 27, 2020. This is a 1-year extension of the original deadline for wholesale distributors to verify a product identifier before further distributing a returned product. (Read our recap of the FDA announcement here.)

As the pharma industry’s thought leader on VRS, rfxcel is ready to talk about this development. Based on what we’ve learned from our VRS pilot, we believe the FDA made the right decision because it will allow the industry to test more production-like scenarios.

No matter what, companies should continue with their planned VRS implementation efforts so they’ll benefit from the continued testing. Companies that wait will not benefit from the extended test cycles and (like previous delays in enforcement) will end up competing for limited resources when the new deadline approaches.

Be sure to ask us questions and get copy of our interim report so you can navigate the DSCSA over the coming months.

A Final Thought: Trust rfxcel to Ensure You’re DSCSA-Compliant

Book an appointment now or just come to Booth 9 at the Traceability Seminar to see how our VRS pilot is measuring and ensuring the seamless interoperability between VRS providers across a broad range of use cases. rfxcel is the longest-tenured track and trace solution provider in the pharma industry and is leading the way on the VRS. We’re ready to share our expertise!

The FDA extension doesn’t change the fact that complete and consistent verification of the VRS use cases is critical to successfully meeting the DSCSA Saleable Returns Verification Requirement. Companies should remain on course and use the extra time to ensure they’re ready for 2020. rfxcel’s team of experts and our leading-edge trace and trace solutions are all you need to ensure you’re always compliant.