October 2018 - rfxcel.com

rfxcel Celebrates Its 15th Anniversary

San Ramon, CA November 1, 2018,  – Today, rfxcel, the leader in track and trace solutions for global supply chains celebrates its 15th business anniversary. Over the last 15 years, rfxcel has grown from a small upstart focused on U.S. compliance to a global product track and trace provider with a footprint in Europe, India, Russia, Latin American, the Middle East, and Asia.

Founded in 2003 by Glenn Abood and Jack Tarkoff, rfxcel was created to help the Life Sciences industry secure and optimize its supply chain operations and deliver safe medicines to consumers. Since its founding, rfxcel has brought consumer-focused track and trace solutions to pharmaceutical manufacturers, wholesalers, distributors, and dispensers. In addition to its geographical expansion, rfxcel has extended its vertical reach to include Food and Beverage, Consumer Goods, and the Public Sector.

“We are now the longest-tenured pure-play track and trace company in the market today. I am proud that we continue to innovate and grow in a highly competitive global market. As I’ve looked back on our 15 years, I’ve reflected on our humble beginnings meeting at our local Starbucks to plan and strategize to now running a world-class supply chain company with hundreds of bright and talented people. I also remain heartened by the fact that we have retained so many of our original customers. That is a tribute to our best-in-class products and service. I am looking forward to the next 15 years!”  – Glenn Abood, rfxcel, Co-founder & Chief Executive Officer.

rfxcel prides itself in delivering flexible solutions that meet compliance standards while also providing additional value. In response to customer needs for greater supply chain visibility, rfxcel migrated from lot-level “ePedigree” to global serialization at the unit level, and expanded its product lines to include Internet of Things (IoT) Environmental Monitoring, Immunization Tracking, and Controlled Substances Tracking for government and law enforcement.

“We set out to create solutions to protect consumers. When we founded rfxcel, there were no complete pharmaceutical track and trace solutions on the market, and there were very few regulations governing pharmaceutical track and trace. We were ahead of the curve then and remain ahead of the curve now because we produce products with the consumer in mind.” – Jack Tarkoff, rfxcel, Co-founder & Chief Strategy Officer

About rfxcel

rfxcel is the most tenured track and trace provider in the market today. rfxcel provides leading-edge solutions to help organizations meet regulatory compliance requirements, protect their products, and brand reputations. For the last 15 years, manufacturers, wholesalers, and distributors throughout industry have trusted rfxcel to provide more than just compliance solutions; they rely on rfxcel’s platform for greater supply chain visibility and value. rfxcel is located across the globe in the USA, EU, Latin America, India, Russia, the Middle East and the Asia Pacific. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs.

Herb Wong

Head of Marketing


(925) 824-0300

Keys to a Successful Solution Implementation Effort

Over the last several years we’ve learned a thing or two about what separates a good or average system implementation effort from a successful solution implementation. Those that are great have a few things in common. Not surprisingly they all have great leadership, excellent communication and follow a plan.

In this blog, we’ll address some of the most critical steps to a successful solution implementation, and what we think is the recipe for success.

Selection is Everything

It’s very common for biotech and pharmaceutical companies to rely on solution providers for their serialization and compliance needs. Identifying and selecting the right solution provider is a lengthy and challenging process. The correct solution provider can mean successful long-term outcomes like supply chain optimization and cost savings, but choose the wrong solution provider, and your manufacturing lines could experience production and fulfillment issues or worse yet; they could come to a screeching halt.

Identify a Project Sponsor

While selecting right vendor is essential, it is just as important to identify the right internal project sponsor to work with the solution implementation team to communicate issues, risks, and status to their organization and work hand-in-hand with the vendor to resolve issues. The project sponsor is typically someone from within the business unit implementing the software, and they have overall internal responsibility and accountability for the success of the project. Finally, they ensure the solution provider delivers on the requirements identified in the Statement of Work or contract.

Create a Project Plan

It seems like a no-brainer, but often in haste to get started, project planning takes a back seat. A good solution provider will put together a project plan with activities and dates. The project sponsor should review the project plan with his /her internal team and make sure there are no issues. If there are dependencies, the project plan should reflect those dependencies.

Identify who will be responsible for updating the project plan and how often it will be updated and stick to it. Driving the schedule and activities helps to ensure implementation occurs on time – if the project plan deviates from the schedule – you’ll be able to communicate why and know the impact quickly.

Trading Partner Identification and Connection Requests

Identifying and alerting all trading partners before implementation not only helps the solution provider make quick work of onboarding trading partners, but also puts trading partners on alert for requests. Trading partners are busy too, and they work best when they know a request to connect is coming. Additionally, early identification of trading partners and their preferred method of connection identifies those with compatible systems and connections and those that do not. Knowing this will allow the implementation team to come up with strategies to address difficult connections and keep the project sponsor apprised of potential risks and issues.

Communicate the Status of Risks and Issues

One of the primary reasons system implementation projects fail is from lack of communication. Before implementation, it is wise to sit down with the project sponsor and solution provider’s leadership team to identify potential risks and issues.  For each risk assess the level of impact and outline a mitigation strategy. However, if a risk should ever become an issue, quickly elevate it to the project sponsor and leadership team. By the time a risk becomes an issue, it’s often too late to mitigate with little to no impact, so it’s best to have a plan to reduce risks to upfront and actively mitigate issues if they should occur.

Conduct Lessons Learned

It may sound cliché, but there is so much to be gained for both the customer and the solution provider by conducting a post-mortem or lessons learned. Even if implementation is a success, it is vital to document what went well. If the project was challenging, this step allows both parties to discuss what went wrong. If there are open issues, it will provide the vendor the opportunity to resolve it for the customer. A good solution provider will always work hard to resolve any issue and make sure things are right and fixed before handoff.

Final thoughts

While there are more steps to any serialization implementation effort, at a minimum follow these, with them you’ll avoid common pitfalls, without them, you’ll experience unnecessary delays and certain difficulties.

Contact us today to learn more about our approach to successful solution implementation, serialization and our track and trace solutions.


Act Sooner than Later to Prepare for Russia Serialization

Russian Federal Law No. 425-FZ, the law requiring serialization in Russia, gives pharmaceutical companies until January 1, 2020 to be fully compliant. This means pharmaceutical companies have less than a year and a half to comply with the most complex serialization requirements to date – without the Russia Serialization requirements fully established and written. 

What We Do Know: 

While it is unknown how the requirements for serialization in Russia may change over the next year, pharma companies who wish to sell their products in Russian markets cannot rely on there being another delay for the deadline. To ensure they can sell in Russia, companies must start to prepare for Russia serialization now. 

The requirements that have been put forth by the Russian government are some of the most complex serialization requirements yet. Currently, companies who wish to sell their products in Russia after January 1, 2020, need to make sure their products are traceable at a unit and a batch level from the creation and packaging of the product to the dispensing of the product. Beyond unit-level traceability, Russia has many requirements surrounding the aggregation of a product. Russia will require special reporting and documentation surrounding the disaggregation and aggregation of units and batches. 

While many serialization requirements for other regions – such as the EU FMD or the USA DSCSA – require only prescription medication to be serialized and traceable, Russia’s regulation requires all medication to be serialized and traceable, including over-the-counter medications. This is a major departure from the global status quo, and a departure that producers of over-the-counter medications are not prepared for. 

What Pharma Companies Need to Do: 

Companies that have not  started preparing for Russia serialization need to start immediately. The uncertainty surrounding the final regulations means that pharma companies need to be prepared for anything – their serialization solution needs to be agile and flexible.  

Due to the comprehensiveness and complexity of the serialization requirements, companies need to be able to produce the type of data Russia will require, as well as be able to produce serialization data for all of their products, including over-the-counter products. Companies that have not yet started converting their production lines need to do so immediately if they wish to sell in Russia. 

Contact us below to learn more about Russian serialization requirements and how rfxcel can help you meet them in time.

To learn more about Russian Pharma Compliance click here.

Act Sooner than Later to Prepare for Russia Serialization


Item-Level Traceability Can Transform Food Businesses

The food industry is undergoing massive changes. Consumer behaviors are changing the way food companies’ source and manufacture foods. A growing amount of food dollars are looking to brands that can make – and validate – claims of local, organic, sustainable and a host of other value-added food attributes. In this environment, companies operating in the food and beverage industry need to have deep insight into their supply chains to compete. Companies that don’t know what’s happening to their products in the global marketplace are at risk, and their supply chains aren’t the assets they should be.  

Digital, end-to-end serialized traceability originally developed and deployed across the global pharmaceutical industry to fight fraud and counterfeiting, provides an essential tool in winning the food game in the new food economy. End-to-end serialization helps to ensure that companies are protected today, and ready to adapt to the challenges of tomorrow. 

Serialization is the process of creating a unique identifier or code for every item sold. Some estimate that serialization can add four orders of magnitude to supply chain visibility in a single step. How? Well, once products are serialized a batch is no longer just thousands of undifferentiated packs, but single, traceable items that have quality metrics associated with their data. Data about the product starting with harvest through its journey to consumer can be tracked at every stage of the supply chain.  

Serious leaders in the food and beverage industry understand that item-level traceability is the future and are beginning to take advantage of what it has to offer. Importantly, the costs for implementing serialization solutions are coming down at the same time the benefits are becoming indispensable. 



Food companies rely on brand promises to drive consumer loyalty, but Food Fraud – including mislabeling and brand counterfeiting – costs businesses $30-$40 billion a year globally. Counterfeiting in high-value products like specialty foods and spirits costs brand value. By labeling products with a unique code, consumers can validate the authenticity of products. Serialization helps to ensure that returned products are authentic, allowing for retailers or distributors to put items back on the shelf with confidence.  



No matter the rigor of food safety protocols, product recalls due to contamination or adulteration are still possible. However, by serializing each product, the size and scope of any recall can be reduced. Each item has a unique identifier that is put into a case which has its own unique identifier. When these cases are loaded onto a pallet, the pallet receives another unique number. By creating and following these parent-child relationships through aggregation and then de-aggregation and distribution, targeted, surgical recalls become possible, ensuring that only impacted product is pulled, while allowing for a safe product to stay on the shelf. 



Getting accurate, real-time data about a product’s disposition is the driver behind the informed decision making that will allow tomorrow’s winners to leverage item-level traceability for competitive advantages. 

That visibility enables a better understanding of the product flow to improve logistics and transportation efficiency, including reverse logistics, and quicker and better decisions for demand forecasting and production planning.  

Being able to see exactly where products are and how long they have been there can reduce losses due to shrink, out-of-stocks and other ills of inaccurate/incomplete inventory. Companies can identify exact locations of bottlenecks in production or key QC points of failure.  Any issues from customers or even consumers can be traced back to the individual item. Just-in-time inventory can become a reality. 



As end-to-end digital traceability becomes the expectation of consumers, serialization will open the door to unlocking the potential of innovative food brands eager to connect with their customers in new and powerful ways.   

By leveraging the unique code on each pack, marketers can use specified incentives and targeted digital messaging to connect with consumers. Companies can talk to consumers to communicate specific messages about ingredients, provenance, harvest date and other relevant information that can help build trust, including handling/testing data for the very item in hand. Couponing, incentives and other brand messages can build brand loyalty and provide targeted incentives to keep consumers coming back – the key to brand development.  

Serialization has become the primary requirement in the pharmaceutical industry, and well-known companies leverage the benefits of item-level track and trace. The leaders in the food industry can realize many of these same benefits. As we’ve seen in other markets, it’s only a matter of time before the benefits of serialization become indispensable.  


food traceability

rfxcel Announces FMD Compliance Solution for Dispensers

San Ramon, CA, October 10, 2018,  –  rfxcel, the global leader in track and trace solutions, has released its compliance solution, rfxcel Code Check (rCC), designed to address the specific requirements of the Falsified Medicines Directive (FMD) for pharmaceutical dispensers and hospital pharmacies.

By February 9, 2019 all pharmaceutical dispensers in the European Economic Area (EEA) must be able to electronically verify and decommission prescription medicines before dispensing. rfxcel has applied its fifteen years of traceability expertise and work with pharmacists to develop a simplified, pharmacy specific workflow that addresses the FMD validation process.

Mark Davison, Senior Operations Director Europe, rfxcel, comments: “The Falsified Medicines Directive will soon impact all pharmacies in Europe, and will require dispensers to verify pack features – tamper evidence and data matrix code – prior to dispensing medicines to the patient. This involves an established and ongoing connection to their National Medicines Verification System (NMVS) as well as a scanner capable of reading the data matrix codes printed on medicine packs. As an accredited FMD service provider, rfxcel can facilitate a secure connection to any NMVS, while rfxcel Code Check (rCC) addresses all the functions required under FMD.”

Functionality within rfxcel’s FMD software has been adapted to build a workflow uniquely designed to enable dispensers to manage split packs, aggregation to bag level during preparation of prescriptions in advance, re-commissioning of items from no-shows, and other pharmacy-specific activities impacted by FMD. In addition, rfxcel Code Check (rCC) offers seamless integration with standard data matrix scanners and is available standalone or as an integrated solution with all major pharmacy software providers, providing a range of options and reducing risk.

Mark concludes: “Organisations in the medicine supply chain, including pharmaceutical dispensers, urgently need clarity and support if they are to meet the complex requirements of the FMD by February 2019, especially amidst continued uncertainty around Brexit. More specifically, they need guidance from experienced solution providers with traceability expertise. The FMD is endlessly challenging, but rfxcel Code Check (rCC) builds these requirements into existing pharmacy workflows and offers a great opportunity to improve patient safety and supply chain efficiency.”

Demonstrations of rfxcel Code Check (rCC)  will be available to visitors to the Pharmacy Show, 7th & 8th October 2018, Birmingham NEC, UK.

rfxcel to Present FMD Compliance Solution at UK Pharma Show

San Ramon, CA October 2, 2018, — Global track and trace software provider, rfxcel, is attending the upcoming Pharmacy Show, which takes place on Sunday the 7th and Monday 8th of October 2018 at The NEC in Birmingham, where it will present its latest FMD compliance solution, rfxcel SNAP, designed specifically to meet the needs of pharmaceutical dispensers.

By February 9, 2019 all pharmaceutical dispensers in the European Economic Area (EEA) must be able to electronically verify and decommission prescription medicines before dispensing. For UK pharmacies, this means new rules for coding and verifying, decommissioning and recommissioning prescription medicines, as well as facing continued uncertainty around Brexit and the UK’s role as a major exporter of medicines. rfxcel is able to help the industry meet these challenges with its simplified, pharmacy specific workflow that addresses all aspects of the FMD validation process.

In addition, Mark Davison, Senior Operations Director Europe at rfxcel, will be hosting a speaker session entitled, “FMD compliance: a simple guide to getting your pharmacy ready for February 2019”.  This session will take place between 12:45 and 13:15 on Sunday 7th October in The Pharmacy Technology Theatre.

Mark will outline the practical expectations that the Falsified Medicines Directive (FMD) is placing on UK pharmacies. Cutting through the hyperbole and misinformation around FMD and Brexit, Mark will focus on the knowledge you need to ensure compliance.

In the session, delegates will benefit from the following learning outcomes:

  • Understand FMD and how it impacts UK pharmacies
  • Get clarity on Brexit and ‘what-if’ scenarios
  • Understand what FMD solutions and tools are available
  • Get proven tips to become FMD compliant… quickly!

Delegates to the event will be able to see demonstrations of rfxcel SNAP and rfxcel’s FMD compliance software at Stand PE26 as well as get a chance to discuss, debate and share the latest issues with rfxcel experts.

Serialisation Requirements: Why risk it? FMD is not going away! Are you ready?

The Falsified Medicines Directive (FMD) imposes strict serialisation requirements on pharmaceutical manufacturers, distributors and dispensers. By February 2019, Marketing Authorisation Holders (MAHs) will need to start uploading serialisation codes for almost all their prescription medicines to the European Medicines Verification Organisation (EMVO) hub for authentication with pharmacists at the point of sale. Those that can’t will simply be unable to sell their products in Europe.

More than thirty countries in the European Economic Area will have new rules for coding and verifying prescription medicines. Despite the significance of the regulation, there are some pharmaceutical manufacturers – and many pharmaceutical dispensers, including community and hospital pharmacies – who have yet to put a strategy in place to assure compliance.

The introduction of serialisation, designed to ensure the authenticity and traceability of individual medicines, promises to improve patient safety and create exciting opportunities for digital health. However, failure to comply with the EU regulation that mandates it means you cannot legally ship your product. No code, no trade. And those in the driving seat are MAHs. We’ve had two-and-a-half years of the three-year implementation window: now, what’s left to do?

Its key to mention, that those of you waiting for Brussels or Brexit to cancel FMD are wasting your time. Even if there is a delay, FMD is not going away and the UK is tied to it until at least Dec 2020.

It is clear that not everything will be ready by February 2019, especially at Pharmacy level, but that doesn’t mean the whole project will stop.

Therefore, rfxcel have put together their top tips to rapidly implement a cohesive serialisation solution.

Simple FMD projects work best.

Only make system linkages you need. Usually (for manufacturers) that means MAH to CMO and MAH to EMVO. For distributors and dispensers it means to your national system (NMVO). While it would be possible to integrate your FMD solution with your ERP software, warehouse system, dispensing software – even your Apple watch if you want to – right now the focus should be entirely on the critical path for FMD compliance. Starting with a standalone approach as part of a roadmap to deeper integration is the best balance of risk and ROI.

Spend money on those that matter.

For every euro spent on vendor technology, several euros need to be spent on your own people and processes to bend them into shape. Don’t skimp on this bit. Pack-level traceability changes everything all along the supply chain. If people carry on with old ways of working your FMD project will fail: expensively.

Experience outweighs the price.

Saving a few thousand euros using unproven, but cheap serialisation vendors, is a false economy if you can’t sell or dispense products by next February. It is too late for home-made solutions or inexperienced me-too suppliers. Competition means that prices are already pretty keen amongst the market leaders. Don’t chase the last cent.

You still have some time.

There is still some time to get ready if you just need software to manage and report serial numbers (e.g. to the European Medicines Verification Organisation, EMVO) or if you’re a downstream distributor or pharmacy needing to verify and decommission packs. If you haven’t started, but can make quick decisions and take standard options, ACT NOW, and you could have your software implemented within the next few months.

Take action before regulators remove your right to trade.

The fact remains that many companies are still some distance from being fit for purpose. The complexities of serialisation mean that a failure to act now could make it extremely difficult to complete implementation in time for the FMD deadline, or at least to guarantee a seamless end-to-end process.

Moreover, with the fees for registering with EMVO and other affiliate repositories increasing, the internal costs of your project will inevitably rise the longer you wait. However, the biggest price of non-compliance will be your inability to ship product. So why risk it?

Contact us below to learn more about serialisation requirements and how rfxcel can help you meet them in time.

rfxcel Extends Solutions to Food & Beverage

San Ramon, CA October 11, 2018, – rfxcel, the Leader in Track and Trace Solutions for the pharmaceutical market, announced today that it is extending its leading-edge track and trace solutions to the Food and Beverage industry. Like the pharmaceutical market, the Food and Beverage industry seeks innovative technologies to protect their consumers and brand reputations from contamination, adulteration, and fraud.  rfxcel’s track and trace solutions offer farm to fork product visibility, providing unprecedented supply chain insights.

Glenn Abood, CEO of rfxcel said “The Food and Beverage industry is similar to pharma. Like pharma, the Food and Beverage industry is under a tremendous amount of pressure to deliver products free of contamination, adulteration, fraud, and diversion. It’s a highly competitive, regulated market with little room for error. Their supply chain operations must be lean, reliable, and automated in such a way that the supply chain learns and adapts quickly. Our track and trace solutions do just that. We are an industry leader in track and trace. Not only does it make sense for us to offer our solutions to the Food and Beverage industry, but I am also pleased that our entry into this segment is a continuation of our founding principle, which is to deliver safe products to consumers.”

rfxcel’s complete end-to-end solution offers Food and Beverage Traceability, Serialization Processing, Ingredients Traceability, Finished Goods Traceability, Compliance Management, Blockchain Enabler, and Environmental Monitoring. rfxcel’s award-winning Environmental Monitoring tool helps to protect products from contamination and enables the quick identification of products for surgical recalls.

rfxcel’s solutions implemented separately or in toto, provide valuable supply chain insights starting at harvest, ending with consumers, and all points in-between. rfxcel’s solutions give suppliers and retailers the ability to optimize their supply chains and keep the food in their supply chains safe; and enable the tracking of ingredients and raw materials through to finished goods, by lot or by item.

“It has never been easier for consumers to enjoy food from other countries or for retail chains to import foods to serve their customers. Moreover, while consumers enjoy choice, they’re equally committed to transparency, provenance, and authentication of the food they eat. Our solutions, and in particular our Environmental Monitoring solution, provide the critical components for companies to realize true track and trace, secure their supply chains, and deliver the transparency the consumer expects.” – said Todd Fabec, Sales Director, Food & Beverage, rfxcel.


About rfxcel

rfxcel is a world-class 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, LATAM, India, and APAC. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs.


Herb Wong

Head of Marketing


(925) 824-0300


Serialization and Validation with rfxcel (Part 3 of 3)

Watch the short interview with Mark and Amit to learn more about our system’s architecture for data quality in a supply chain. Contact us for a quick demo.

MARK DAVISON: Head of Europe for rfxcel Corporation – a global leader in traceability solutions. He has started EU and Russia operations for rfxcel, devising the regional strategy, hiring staff and managing fast growth. He was voted onto Medicine Maker magazine’s Power List of 100 most influential people in pharma manufacturing and development. He has technical expertise in anti-counterfeiting technologies and vendor selection, including authentication, serialization, and traceability.

AMIT SEWAK: Responsible for contributing to the rfxcel’s mission and vision by designing, strategizing, assessing, planning and implementing the performance improvement programs to meet the needs of the organization. He provides leadership and strategy in regulatory, compliance and technical guidance to staff for digital IoT products. He functions as the Management Representative that maintains oversight responsibility for all Quality Management Systems.

Since every system, even a well validated one, is prone to errors that are flowing from outside, Mark and Amit speak about the engineering of rfxcel’s system which is designed to catch as many of those errors as possible.

Over the last three years rfxcel has consistently been able to identify almost 96% of our issues up front, before they get to our customers. Our product has the ability to pick out duplications and transmission errors between fields which other systems pass through. One of the attributes of our system is its monitoring ability which is tailored to your compliance needs.

With rfxcel you can pick a solution which partners with you and allows you to have the growth you need, while the system expands as well.

Serialization and Validation with rfxcel (Part 2 of 3)

Watch the short interview with Mark and Amit to learn more about the compliance factors and requirements that are essential when evaluating a software vendor for serialization. Contact us for a quick demo.

MARK DAVISON: Head of Europe for rfxcel Corporation – a global leader in traceability solutions. He has started EU and Russia operations for rfxcel, devising the regional strategy, hiring staff and managing fast growth. He was voted onto Medicine Maker magazine’s Power List of 100 most influential people in pharma manufacturing and development. He has technical expertise in anti-counterfeiting technologies and vendor selection, including authentication, serialization, and traceability.

AMIT SEWAK: Responsible for contributing to the rfxcel’s mission and vision by designing, strategizing, assessing, planning and implementing the performance improvement programs to meet the needs of the organization. He provides leadership and strategy in regulatory, compliance and technical guidance to staff for digital IoT products. He functions as the Management Representative that maintains oversight responsibility for all Quality Management Systems.

In this interview Mark and Amit discuss what questions you should be asking when evaluating a solution provider for serialization.

There are three key compliance factors you should take into consideration when evaluating software vendors for serialization, according to Amit.

The first one is maintaining your validated statement. If the vendor keeps providing you with continuous updates, you need to constantly validate to maintain the state of compliance which can be a very laborious and costly task.

The second factor to consider is how well the risk is being controlled on your end.  If the vendor keeps providing you with the risk process upfront, you as the recipient can make your own risk decisions.

The third factor to take into consideration is the transparency of the improvements that the vendor makes to the software, keeping you up to date with all the changes and improvements.

rfxcel ensures the transparency for the manufacturers, distributors and dispensers, providing the best quality of data.