July 2018 - rfxcel.com
EnglishFrenchGermanItalianPortugueseRussianSpanish
A Part of Antares Vision Group

rfxcel VRS Pilot Open to All Supply Chain Partners

San Ramon, CA July 31, 2018 – rfxcel, the global leader in track and trace solutions, announces the start of rfxcel VRS Pilot, which is now open to all pharmaceutical trading partners.  This is a major step in helping organizations meet the U.S. Drug Supply Chain Security Act (DSCSA) requirement for Saleable Returns.

rfxcel is already working with VRS participants from the “Big Three” wholesalers, manufacturers, repackagers, national/regional pharmacies and dispensers.  To support the readiness of the industry, rfxcel is taking the next step and is extending its VRS pilot to all DSCSA stakeholders.

“This is a significant commitment from rfxcel to meet a critical need in the pharmaceutical industry.  VRS is important to the success of DSCSA.  We realize that there are many who need to evaluate the readiness of their organization.  To facilitate this, rfxcel is taking an unprecedented step and opening up our VRS Pilot to all trading partners,” said Atul Mohidekar, Chief Technology Officer of rfxcel.

VRS is an industry initiative sponsored by the Healthcare Distribution Alliance (HDA). It allows pharmaceutical supply chain partners to quickly exchange data and verify the validity of a product being returned for sale.  The end goal of this effort is to ensure the authenticity of products and the safety of patients and consumers.

rfxcel VRS effort will support both Requestor and Responder scenarios to ensure end-to-end compliance. Using the Responder functionality, manufacturers and repackagers will be able to respond to verification requests. Distributors will be able to use the Requester functionality to verify authenticity of the resalable products.  A key requirement of VRS is the support for a Lookup Directory (LD), which enables quick delegation of requests to the proper owners. rfxcel will provide the LD functionality to facilitate routing of product authentication requests. rfxcel will also provide an option to use blockchain-based VRS and the LD solution to align itself with industry initiatives. With the combination of VRS, LD, Responder and Requester capabilities, rfxcel will be able to provide the full spectrum of verification functionality to manufacturers, repackagers and distributors to comply with the DSCSA law.

“rfxcel has always supported an open partner ecosystem.  We are committed to working with HDA, our customers and other pharmaceutical trading partners to help secure the supply chain.  This effort will save lives and it is imperative to have this in place for patients and consumers.  Opening up rfxcel VRS Pilot to the industry will help to accelerate this process,” said Glenn Abood, Chief Executive Officer of rfxcel.

 

To learn more about rfxcel  or participate in rfxcel VRS pilot please contact us at Contact Us.

 

About rfxcel

rfxcel is a supply chain track and trace company. rfxcel provides leading-edge track and trace solutions to help companies meet regulatory compliance requirements, protect their products, and brand reputation. rfxcel has been an industry leader since 2003, expanding to locations beyond the US to include the EU, India, Brazil, and Japan. rfxcel’s unique integrated track and trace software suite delivers better business outcomes and lowers supply chain costs.

 

rfxcel vrs

3 Months to DSCSA Serialization Enforcement

With only 3 short months to go, all manufactures and repackagers need to be ready for the FDA’s DSCSA serialization enforcement. Drugs sold in the United States must comply with the FDA’s Drug Supply Chain Security Act (DSCSA) deadline to have item-level serialization affixed or imprinted on unit-of-sale prescription drugs sold in the United States.   

On June 30, 2017, the FDA issued Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. This guidance informed supply chain stakeholders that the FDA would delay DSCSA serialization enforcement of product identifiers on prescription drug packages and cases until November 2018. This delay provided manufacturers additional time to put in place technology to generate product identifiers and avoid supply chain disruptions.

While product identifiers—commonly referred to as serialization—is the backbone of the DSCSA, it is just one of many requirements. Each node within the supply chain, from manufactures all the way down to dispensers, must meet a unique set of DSCSA requirements. These unique requirements have presented new challenges to companies of all sizes within the drug supply chain. Recently, many of those challenges came to light at a Healthcare Distribution Alliance (HDA) meeting, in which industry leaders exchanged their experiences and the many challenges that still lie beyond the November 27, 2018 serialization deadline.

 

How rfxcel is helping companies get ready for DSCSA serialization enforcement:  

The November 2018 deadline accelerates the need for rfxcel’s traceability solution. In order to achieve full compliance, members of the supply chain including manufacturers and wholesalers all the way down to dispensers need collaborative technologies that track and trace a product, no matter the maker or origin, throughout the supply chain. The DSCSA details how the manufacturer must start the process of tracing a product by producing the transaction history, transaction information, and a transaction statement of the individual batches and units. This information is then passed to each actor within the supply chain to continue the drug history. Serialization is the crux of the effort allowing for the eventual tracing back up the supply chain for returns and recalls.

rfxcel understands the intricacies of the supply chain and how easily a business can be consumed by compliance efforts. This is why rfxcel closely partners with customers to understand their business strategy and objectives without losing sight of regulatory compliance. This is achieved through establishing a clear project structure, open lines of communication, collaboration, approved technical requirements, and a ‘Gold Release’ implementation effort that does not disrupt business operations.

‘Gold Release’ Implementation Plan: 

Larger pharmaceutical companies have been doing serialization for over 15 years. Even still, many of these companies had to adjust to the DSCSA serialization enforcement requirements. In late 2016, a number of these large pharmaceutical companies wrote to the FDA indicating they were facing challenges meeting the serialization deadline. The FDA wisely determined that if these large companies were having issues meeting the deadline, then smaller companies must be having similar issues. The FDA agreed to delay the deadline by one year establishing a new deadline of November 27, 2018.

Based on the issues many companies were having, rfxcel created an express on-boarding plan to expedite pharmaceutical companies’ compliance with the DSCSA. Dubbed the ‘Gold Release,’ rfxcel developed templates and compliance modules for rapid compliance implementation. The ‘Gold Release’ is a repeatable process that enables deployment events to occur faster and trouble free, providing a simple approach to meet compliance while controlling costs and minimizing business impact.

Supported with collaboration:

Historically, while the pharmaceutical supply chain has worked in a stove-piped fashion, traceability paired with the requirements of the DSCSA requires total collaboration across the industry. In that spirit, rfxcel leads collaborative efforts with working groups and classes among industry partners. Transparency and ongoing collaboration ensures that customers are able to learn and implement successful track and trace efforts. For example, rfxcel educates members on current and potential regulatory requirements, how to on-board new trading partners, and how serialization works.

Full-service approach:

Many small pharmaceutical companies face challenges with DSCSA serialization enforcement including master data management and data exchange with contract manufacturing organizations and wholesalers. rfxcel designates teams across the globe ready to support the entire serialization and track and trace process.

Regardless of size of the company, rfxcel will always find the most cost effective and easy to use solution to comply on time and build business value beyond compliance. When developing the supply chain strategy, rfxcel considers regulations like the DSCSA, and any global differences in associated product descriptions with related literature and support materials.

Awareness and understanding of guidelines and regulations for the serialization of pharmaceuticals products are critical. This awareness includes compliance with regulations (current and planned) that ensure the authenticity, safety, and security of the product.

 

About DSCSA:

The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. The goal is to  protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain.

 

About rfxcel

Headquartered in the United States, rfxcel is the leading cloud-based provider of serialization, and track and trace solutions. For over fifteen years, rfxcel has provided reliable and affordable solutions to meet global serialization and compliance requirements. With rfxcel’s relentless commitment to customer success and continuous innovation, companies can meet today’s compliance requirements and tomorrow’s business challenges.

rfxcel is the number one managed cloud company for Life Sciences. Everything rfxcel offers is managed by rfxcel not the customers. That’s because rfxcel believes:

  • Commitment to customer success promises a prompt, full-service method of addressing customers’ serialization needs.
  • Economies of scale are nice — but economies of expertise are even more valuable. The highest performance and cost-efficiency come when you combine infrastructure with specialized expertise and the exceptional customer service that we call HyperCare
  • Every customer has easy access to engineers, project managers and experts to help with planning, architecting, building, and operations.

Contact rfxcel for information how to meet your serialization, traceability and compliance requirements. rfxcel is a company committed to innovation and affordability in delivering best-in-class track and trace to Life Sciences across the globe.

 

No Leniency for Wholesale: Start Preparing Now to Meet the DSCSA VRS Deadline

The DSCSA VRS deadline is one of the most important milestones the pharmaceutical industry needs to meet. The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013, in doing so amending the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs.

Title II of the bill, the Drug Supply Chain Security Act (DSCSA) is designed to establish requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. It outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed. This will enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect consumers.

Adopting a phased approach, there are two key deadlines for different stakeholders: November 26th 2018 is the widely acknowledged deadline for pharmaceutical manufacturers and repackagers; however, given that the FDA has already pushed this deadline back once by a year (from November 2017), the second deadline is unlikely to be met with similar lenience.

On November 27th 2019, the DSCSA VRS deadline is enacted.  The wholesale industries must be compliant and only accept products that contain a serial number or product identifier, and they must verify this product identifier before they can go on to resell these goods. They must also be able to complete a validatable returns process.

To complete this process in specific regard to returned products that are saleable, the Verification Router Service (VRS) initiative was highlighted by the Healthcare Distribution Alliance (HDA) in its efforts to lead the industry in implementing the act. Essentially the VRS community consists of a third-party routing service, comprising requestors, responders, VRS providers, and a governance body to help manufacturers and distributors work together.

Under the proposals, the responders – ie. the manufacturers –  are responsible for providing repository connectivity information to the VRS and providing appropriate responses to the requesters’ (ie. the wholesale distributors) verification requests by matching the product identifier received from the requester with the product identifier in their repositories.

This level of collaborations requires tools for manufacturers and distributors need to work together. And these tools require testing – in minutiae.

Today, various solution providers, including rfxcel are in the process of providing a VRS. By the end of Q2 2018, industry testing is expected to start. The industry testing will consist of two rounds of testing, where there will be updates and modifications to the VRS specification to accommodate learning’s from the first test. Final revisions and refinements of the VRS will go in place with the final report published by the end of Q4 2018. Therefore, the VRS is expected to be available in early 2019, in readiness for the November deadline.

Lessons learned

However, as mentioned, it’s unlikely that the FDA will be lenient with this second deadline. It is therefore important to be aware that the duration of the testing depends on a lot of different things. It is going to be dependent on the readiness of your trading partners to start testing, and be determined by the quality of the data you received. You will need to expect some problems and be able to account for that within your schedule.

Analysing the recent HDA meeting back in February, we have put together our top tips to ensure you meet the upcoming DSCSA deadline:

  • Start talking with your providers, NOW! If you haven’t started implementing solutions yet or looking into your options, this is the perfect time to start.
  • If you are selecting vendors, make sure you understand the level of service provided by these providers. Everyone has a different way of managing the implementation process, so it’s not all the same.
  • Understand the total cost of ownership or the total cost of implementation. Make sure you have resources in the budget for that so you’re not surprised when the project starts.
  • We recommend that engage your trading partners to mutually understand the impact of your plans. This is probably the most important phase that you’ll need to go through. Your trade partners have different schedules, they may have different commitments to other customers that they are exchanging information with. So as part of this, make sure you understand the proximity exchange and make sure you reach out to your key suppliers in time.
  • Finally, the HDA does require continued testing implementation regarding serialized items. Make sure that you schedule ample time to test the implementation. Run through the proper test cases with your trade partners as part of the on-boarding process.

To learn more about the DSCSA VRS deadline and rfxcel’s VRS pilot project please contact us.

 

Legal Note *We are very familiar with the DSCSA requirements and the DSCSA implementation we are not familiar specific trading partners or contracts or business requirements. As a result we do recommend that you have them all reviewed by your legal team to make sure that DSCSA law and DSCSA VRS deadline might apply for your specific situation.

DSCSA VRS deadline

Walmart EVP and Amgen SVP Join rfxcel’s Board of Directors

San Ramon, CA  July 18, 2018 – rfxcel, leading track and trace software provider, announced today that Chris Sultemeier, formerly from Walmart, and Martin Van Trieste, formerly from Amgen, have joined rfxcel’s Board of Directors.

Chris Sultemeier brings over 30 years of leadership experience in supply chain operations to the rfxcel organization.  Chris was the Executive Vice President of Logistics at Walmart, as well as the President and CEO of Walmart Transportation LLC. During his tenure, he was responsible for all domestic and global distribution and fulfillment.  Chris received the prestigious Sam M. Walton Entrepreneur of the Year Award for his efforts on sustainability. Chris also serves as an instructor at MIT’s (Massachusetts Institute of Technology) Master’s Degree program for Supply Chain/Logistics/Transportation.

“I spent a life time working to improve supply chain efficiency; working with the industry leader, Walmart, I was fortunate to spearhead many new innovations which have now become common place.” says, Chris Sultemeier.  “I look forward to bringing this experience to a new leader, rfxcel, who will bring improved visibility and control to the supply chain across a wide-range of industries.”

“Chris’s expansive knowledge of supply chain tracking and optimization, combined with rfxcel’s world-class traceability platform will bring new business value to many organizations.  Chris’s vision and enthusiasm for transforming the supply chain is infectious and I am excited to welcome him to the rfxcel’s Board of Directors.”, says Glenn Abood, CEO.

Also joining the rfxcel board is Martin Van Trieste.  He is currently the Immediate Past Chair of the Parenteral Drug Association (PDA) which is committed to developing scientifically sound, practical technical information, and expertise to advance pharmaceutical and biopharmaceutical manufacturing science and regulation so members can better serve patients.

Martin’s experience includes serving as Chief Quality Officer and SVP of Quality at Amgen, as well as VP of Quality at a number of large biopharmaceutical companies. Martin’s decades of experience provide rfxcel with a varied and comprehensive knowledge of the industry.

“I am excited to join rfxcel in its mission to provide serialization, and track and trace technology to protect patients and consumers.  As a former SVP of Quality, I was drawn to rfxcel because of its commitment to quality.  rfxcel’s solution provides the most extensive verification of data in the industry. This commitment to quality data is essential to protecting consumers and the supply chain.”

“rfxcel has had the privilege of working with Martin over a number of years.  He has demonstrated the capacity to think strategically and deliver tactically.  We look forward to the new insights and leadership that Martin will bring to the rfxcel’s Board of Directors.”  said Glenn Abood, CEO.

 

For more information about rfxcel’s Board of Directors:

Herb Wong, VP of Marketing

hwong@rfxcel.com

www.rfxcel.com

 

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. Their platform enables companies to protect patients, comply with regulatory mandates, and gain visibility into their supply chain. rfxcel’s relentless commitment to customer success and continuous innovation ensures that companies can meet today’s requirements and tomorrow’s challenges.

Walmart, rfxce'sl Board of directors

Countdown to Complying with the Serialization Requirements of the Falsified Medicines Directive

Winning the numbers game: Countdown to complying with the serialisation requirements of the Falsified Medicines Directive

The Falsified Medicines Directive’s (FMD) February 2019 deadline is fast approaching. Those who don’t serialize by this deadline will be unable to sell their products in Europe.

The regulations set forth by the FMD state that every Marketing Authorization Holder (MAH) must upload serialization codes to the European Medicines Verification Organization.

But serialization isn’t a straightforward numbers game, and not all solutions are created equal. rfxcel has provided this document to help you determine how you need to serialize and what you need out of your serialization partner.

Serialization is a daunting, frustrating journey, but having the right solution and the right partner can make a world of difference.

This document aims to help you:

  1. Understand the regulation
  2. Identify the right partner for a serialisation solution
  3. Take these actions

European Union Falsified Medicines Directive Is Nearing

The European Union Falsified Medicines Directive (FMD) is close to taking full effect. On February 9, 2019, all regulations regarding serialization and traceability become enforced. Failure to comply with these regulations will inevitably cause product launch delays. No serial number means no sale.

Serialization will be a necessity for sale of virtually all prescription only medications in Europe. But it is not enough to just print a serial number onto every batch.

Each individual unit must contain a 2D data matrix barcode that contains a unique Global Trade Item Number (GTIN) that refers to a specific stock-keeping unit, a unique serial number, the batch number, and the product’s expiry date. Some countries require even more information.

Further, each individual product needs to be able to be traced from manufacturer all the way to the pharmacist’s point of sale. For the pharmacist to be able to reference this information, each unique barcode will be logged with the European Medicines Verification Organization (EMVO) hub.

The process for becoming compliant is not short, and putting off starting the serialization journey is dangerous, especially as the EMVO on-boarding queue starts to bottleneck as more and more companies enter that stage in their serialization process. Acting fast can save months of time and ensure compliance by the February 2019 deadline.

But choosing the right partner with the right serialization solutions can help this otherwise onerous process, as well as help with compliance in other regions, as deadlines for serialization in other countries are also fast approaching.

With our 60 day implementation plan, rfxcel provides a quick on-boarding plan for all of your serialization needs. rfxcel’s solutions are secure as well as comprehensive, providing compliance for a multitude of regions, including the EU.

For more information on the European Union Falsified Medicines Directive and compliance needs, rfxcel provides a number of resources, including a comprehensive whitepaper found here

European Union Falsified Medicines Directive

Webinar: Serialization Requirements in Russia

THIS WEBINAR ENDED. YOU CAN ACCESS THE RECORDING BELOW.

———

Thursday, July 19th, 2018
13:00 BST – 14:00 CEST – 7:00 am CDT – 9:00 am Brasilia

Please join rfxcel for a webinar in which we will share what we have learned thus far regarding serialization in Russia. The “Federal State Information System for Monitoring of Drugs Circulation from a Manufacturer to a Final Consumer with the Use of Labeling (FSIS DCM)” has established a set of standards for pharmaceutical offerings produced for the Russian market. Even with a pilot program in place, the final requirements have not yet been decided.

This webinar is presented by a major multinational customer of rfxcel working on serialization and complying with regulators. During this session, attendees will have the opportunity to write in questions that will be followed-up on via email after the conclusion of the webinar. If you are unable to attend at the scheduled time, we encourage you to register anyway. We will be sharing this recording with all registered attendees.

About rfxcel: 

rfxcel is the leading provider of FMD solutions for manufacturers, CMOs, distributors, and dispensers. The EMVO-certified platform enables you to protect your patients, comply with regulatory mandates, and gain visibility into your supply chain. rfxcel’s relentless commitment to customer success and continuous innovation ensures that you can meet today’s requirements and tomorrow’s challenges.

PLEASE FILL OUT FORM TO ACCESS WEBINAR RECORDING: