September 2017 -

rfxcel Drives EU Expansion with Industry Experts

rfxcel will expand its capability to enable Life Sciences companies to meet serialization and regulatory compliance needs in the European territories. The company, which already has a presence in 4 continents, announced on Monday that it will accelerate its global expansion to operate throughout Europe.

rfxcel is staffed with industry leaders that understand the importance of data accuracy, global compliance and serialization processing. This approach has made rfxcel the leader in traceability and serialization.

Mark Davison is a leading expert and published author in Serialization and EU Pharma technologies. He will head up the rfxcel team in the European territories as the Senior Director of Operations for Europe.

“Data accuracy matters in serialization. Unfortunately, experience tells us that most solution providers only push data and events through without verifying if it meets regulations, or even check for duplication in generating serial numbers. At rfxcel we believe that customers need to think of accurate data processing from the beginning and we provide a more active data validation approach as standard.” – Mark Davison, Senior Director of Operations Europe.

rfxcel will be hosting a discussion at the Pharma TrackTS! 2017 conference in Berlin September 28th and 29th. Mark Davison and rfxcel’s Chief Strategy Officer, Jack Tarkoff, will be speaking about the importance of data validation and its effects on supply chain management.  

As the pioneer and leader in track and trace solutions for the Life Sciences, rfxcel provides solutions to ensure customer success and secure their business. rfxcel is excited to help fulfill the serialization and compliance needs within Europe.

For more information contact us:
Herb Wong, VP Marketing

Key Industry Terminology

Key Industry Terminology

rfxcel is the leading enterprise software for supply chain and traceability. Major pharmaceutical companies, independent CPOs/CMOs, and wholesalers rely on rfxcel’s expertise in compliance software and support. rfxcel has specialized in core pharmaceutical areas including compliance, tack and trace, serialization and environmental monitoring. Along with a global team and strategic partnership with Verizon, rfxcel has become the #1 independent traceability solution . rfxcel supports its customers in their decision making with rfxcel’s unique 360° approach encompassing capabilities covering global and local markets. rfxcel is committed to its primary mission of supporting customers needs regarding compliance regulations. With absolute visibility into customers’ products, rfxcel is provides value beyond compliance, improving patient safety, customer control and peace of mind.

Comprehensive Guide to DSCSA Compliance and Requirements

The Drug Supply Chain Security Act (DSCSA) instituted sweeping changes to how prescription drugs are shipped, distributed, traced, and verified.

The U.S. Food and Drug Administration (FDA) began rolling out the requirements a decade ago. And though the Agency announced that an “extended stabilization period” would be in effect until November 27, 2024, all stakeholders should continue preparing for the full serialization of the supply chain.

If your organization is a part of the pharmaceutical supply chain, you need to familiarize yourself with DSCSA regulations, especially those that come into force in 2024.

This guide will provide a high-level overview of the provisions of DSCSA, including technological solutions that can support your compliance and prospective challenges you may encounter along the way.

Understanding DSCSA: A Quick Review

The DSCSA is part of the Drug Quality and Security Act (DQSA), which Congress enacted in November 2013. The DSCSA outlines steps to achieve pharmaceutical product tracing by creating an interoperable system between pharmaceutical supply chain members, including:

  • Manufacturers
  • Wholesale distributors
  • Dispensers
  • Repackagers
  • Healthcare organizations

The purpose of the DSCSA is to limit the spread of illegitimate products and protect consumers. These requirements will also help regulators detect and remove potentially dangerous drugs from the supply chain.

DSCSA standards began taking effect as early as 2015. However, the more significant changes, such as unit-level tracing requirements, didn’t go into effect until several years later.

Key Components of DSCSA Compliance

To achieve compliance with DSCA regulations, members of the pharmaceutical supply chain must take the following steps:

  1. Facilitate product identification (serialization) at the package level
  2. Provide transaction statements for product tracing
  3. Verify product identifiers for certain prescription drugs
  4. Become authorized trading partners (ATPs) and electronically verify that their trading partners are also ATPs

DSCSA Compliance Timeline

The FDA has been rolling ou the DSCSA requirements in phases over the last decade. Notable milestones of the DSCSA include the following:

  • On January 1, 2015, the DSCSA required all pharmaceutical manufacturers to print lot numbers on prescription drug packaging.
  • On November 27, 2018, the DSCSA required repackagers and manufacturers to include expiration dates and serial numbers on packaging.
  • On November 27, 2019, the DSCSA required wholesalers to verify prescription drugs before reselling them; they can only buy and sell products with the appropriate barcodes and serial numbers and must capture serialized product data for tracing purposes.
  • On November 27, 2020, dispensers had to enact authentication policies to verify all medicines before purchasing them or selling them to consumers; they’re also required to store all transaction data.

Under the original timeline for DSCSA compliance, November 27, 2023, was the deadline for full compliance. However, as we said above, the FDA postponed enforcement by one year, to November 27, 2024.

Compliance Requirements for Different Stakeholders

DSCSA compliance requirements vary for each stakeholder.

Pharmaceutical Manufacturers

  • Product tracing
  • Serialization

Wholesale Distributors

  • Verification of product authenticity
  • Investigation of suspicious products
  • Notification of any suspect products


  • Verification of product authenticity
  • Maintaining transaction information


  • Repackaging and relabeling pharmaceuticals in accordance with DSCSA guidelines

Understanding the unique requirements your organization must meet is key to achieving and maintaining DSCSA compliance.

Technological Solutions for DSCSA Compliance

DSCSA compliance software is the key to gathering product transaction information and relaying data to trading partners. Examples of DSCSA compliance software include:

  • Serialization tools
  • Internet of Things (IoT) and RFID technology for real-time tracking and monitoring
  • Compliance management systems for recordkeeping

To achieve compliance, your organization must leverage several complementary technologies. For instance, serialization tools will allow you to assign a standardized numerical identifier to each product, and IoT technology will support real-time package tracking as drugs travel through the supply chain.

Data Management and Integration

To manage the large volume of serialized products and associated data, you and your trading partners must collaborate in an interoperable manner. Data interoperability means your systems can exchange, share, and consume data with one another — all in compliance with DSCSA regulations.

While achieving interoperability is essential for DSCSA compliance, you must also be conscious of data security and privacy considerations. This is especially important for dispensers, which deal directly with HIPAA-protected patient data.

Regardless of what role your organization plays in the supply chain, it’s important to do your part to protect sensitive data and keep it out of the wrong hands.

Training and Education for DSCSA Compliance

Keeping your personnel up to speed on evolving regulations is vital to compliance success. To do this, you must design and implement a comprehensive training and education program. Additionally, you must ensure that your trading partners are also educating their staff on DSCSA compliance requirements.

When designing education programs, strive to deliver information and guidance in a digestible way. Instead of inundating your team with massive amounts of information, host a series of sessions to maximize retention. As new regulations are announced, modify your training content to keep staff apprised of the latest requirements.

Auditing and Validation

You can never assume compliance when dealing with complex regulatory frameworks like the DSCSA. To protect business continuity and avoid penalties, it’s imperative to engage in regular self-auditing. You should also consider partnering with a third-party provider to obtain an objective perspective on your state of DSCSA compliance.

Audits will help you validate compliance systems and identify potential weaknesses in your operations and strategy. You can use these insights to make improvements, maximize efficiency, and be prepared in case of a regulatory inspection.

Common Challenges

A variety of potential obstacles lie on the road to DSCSA compliance, including:

  • Difficulties associated with identifying compliance risks
  • Dealing with non-compliance issues
  • Balancing compliance costs with the benefits of maintaining ATP status
  • Staying ahead of regulatory changes

Despite these challenges, you can maintain compliance by combining robust data management technologies with a proactive approach. Working with the right solution provider will help ensure you’re always compliant.

Looking Beyond Compliance

Try not to view DSCSA compliance as another administrative hoop to jump through; instead, consider it a competitive advantage. Adapting to the evolving regulatory landscape can future-proof your organization and grant you full access to emerging business opportunities.

No matter how you look at it, DSCSA compliance is an investment in the longevity and success of your business and your partners’ businesses, and securing the safety of pharmaceutical supply chain.

Final Thoughts

If you haven’t achieved full DSCSA compliance, there is still time to be ready. The good news is you don’t have to tackle things on your own. Finding a trusted solution provider is the best way to fuel your compliance journey and be sure you’re ready by November 2024.

Not sure where to begin? rfxcel can help you meet the DSCSA requirements. Our powerful, user-friendly serialization, traceability, and verification technologies can be customized to meet your unique needs.

Contact us today to see how it works. One of our DSCSA experts can show you a demo, answer your questions, and explain how we can collaborate as partners to ensure your organization is prepared.

Seven Secrets of Serialization

Seven Secrets of Serialization

Do you know what’s happening to your products out there in the global marketplace? That knowledge could be the difference between security and vulnerability for you and your customers. Traceability has become a key tool for quality improvement in several industries and is a vital weapon in the war against counterfeits. Your supply chain peers tell us that implementing and managing traceability or serialization software is one of their key concerns. It is indeed a challenge but by learning from their experience, and using an experienced vendor, it doesn’t have to be as difficult as you think.

At rfxcel, we design software systems to handle supply chain traceability in fast-moving, highly regulated and fully validated environments like the pharmaceutical industry. In this short white paper, we’ll share some of our design philosophy and some practical things we’ve learned along the way during customer implementations.

Data Matters in Serialization (Part 6 of 6) – 60 Day Serialization Implementation Plan

rfxcel can generally implement your system within 60 days. We do this not by cutting corners but by designing lean systems and processes and by employing people who are trained and experienced. Mark Davison, EU based serialization expert for rfxcel, discusses the importance of serialization initiatives being tailored to each business to ensure a smooth serialization implementation. His experience has allowed him to witness systems take many months to get ready when in theory it was should have been quick. The difference between a smooth implementation and a costly, lengthy implementation, is ultimately contributed by the vendor.

Many companies find issues arise at the design stage. This is a great time to contact a solution provider to assist process from the beginning with your serialization software. Thinking about serialization process and requirements, master data, or serialization implementation processes gets complicated and should be done with an expert partner.

rfxcel is assisting customers much more beyond the setup process. The team of experts can ensure a quality job from the very beginning. Experts are available to talk to and advise with legal regulations and anything that you need to get you ready. It is an important phase in the health and the life cycle of your products and an your IT systems. (Hear from our VP of Professional Services on rfxcel implementation serialization plan)

At rfxcel we stand behind our promise, we can deliver most systems that are standard with in 60 days. If there is doubt that a company’s  implementation is going to take 1 year and a half, it is a good time to speak to a provider that can deliver.

If you have been halfway through a really painful implementation and you don’t think it is going to work, come talk to us. We know what we are doing, we have people who have systems that are tested and proven. And we will help your through every step of the process. The standards we have on our teams are higher than normal to ensure that the customer is guided through the implementation smoothly. Whether your company is big, small, simple or complex, our teams can work at finding the best solution to compliance.

Data Matters in Serialization (Part 5 or 6) – Data Validation in Pharmaceutical Serialization Software

It is nonnegotiable for a vendor to provide full data validation your serialization. For example, if your production line generates 100 duplicate serial numbers, rfxcel system will catch that and flag it. Some major serialization vendors push the data validation responsibility to you. Mark Davison, EU based serialization expert for rfxcel, discusses the differentiators between serialization and track and trace solution providers in regards to data validation in Pharmaceutical Serialization Software. One of the critical things that companies need to think about is, how to build data checks into their system. How to make sure that garbage in, does not equal garbage out in Pharmaceutical Serialization Software?


It is essential to build data validation steps into the framework of the system so that if the system is outputting data that is wrong it will not affect a company’s productivity. The system must be able to catch bad data and prevent it from getting into the supply chain. However, not all Pharmaceutical Serialization Software will do that. Some systems will pass on that data and it will go down the pipe and onto your business partners and onto your supply chain and cause damage.


Purchasing a system that does not validate the data is very risky.  It is advised to ask before purchasing a solution when and how they will check the data. The serialization software solution (Learn more about rfxcel Serialization Softwarewith accurate data will provide you much value beyond compliance.


A smart serialization solution will provide you the tools to look forward into what is next. What can a company do with data collected once they are compliant? Maximizing customers’ ROI after investing into rfxcel Traceability System is important to us because there is much to gain beyond compliance.


Serialization is a compliance driven issue today but tomorrow there is huge business value in the processes. The serialization tools can make the difference between a positive ROI and a really messy, expensive serialization experience.

Data Matters in Serialization (Part 4 of 6) – A Serialization Software for Regulatory and Compliance Requirements & Beyond

It’s important to choose a vendor that has the people and the software to provide you a complete serialization and traceability solution. rfxcel’s implementation specialists have the knowledge and technical background to integrate into various systems you need. Mark Davison, the EU based serialization expert for rfxcel, continues the discussion with an emphasis on choosing a track and trace solution that is more than meeting the regulatory compliance for pharma and biotech products (Learn more about rfxcel Regulatory Compliance Software). It is one of the last mentioned topics in the serialization meeting but takes a lot of time when implementing and deploying the system.

The modern pharmaceutical supply chain is not the monolith it was 50 years ago. Most drug companies don’t make their own product, in most cases they outsource resources including their packaging. This causes most companies to have multiple business partners that have to be involved in the supply chain and ready to exchange data.

The process of data exchange both to and from systems will impact the implementation process once a serialization provider is selected.  It is crucial that the solution provider has a clear understanding of business partners, data processing and a company’s overall requirements for reporting the data throughout the business partner network. How a company manages that process could mean the difference between an easy and difficult implementation.

rfxcel develops simple interfaces to help prepare companies and partners for quick and efficient implementation.  Thinking of requirements for your system is a great start for a clear and fast start with your project management team at rfxcel. And it will maximize data validation process in the software that you don’t have to do later.

Data validation is absolutely critical in serialization and one of the trickiest things to get right. In the Pharmaceutical serialization, the law is pretty clear in most major jurisdictions about how you have to validate the data and in fact, good automated manufacturing practice from the International Pharmaceutical Engineering is pretty clear on how companies should go around validating a system in specific ways. Not only do rfxcel teams work with your partners, they understand U.S. Drug Supply Chain Security Act (DSCSA) or the E.U. Falsified Medicines Directive (FMD) so companies don’t have to worry about them.

There are many ways that companies take shortcuts with cloud-based systems. These shortcuts work well that some environments but not so well in highly regulated pharmaceutical supply chain environments. A heavily regulated and validated environment requires a company to prepare for audits and heavy fines that come with poor data reporting.

At rfxcel, we understand this risk, so we emphasize a secure and stable system that is reliable; day after day, week after week. It is not a one-time implementation and one time fix, it is a lasting solution that is reliable and stays up to date with the evolving supply chain regulations so you don’t have to worry about it.


Data Matters in Serialization (Part 3 of 6) – Serialization Implementation Plan & Support

Data attributes and reporting requirements differ between markets. National system requirements, with short deadlines, can appear from nowhere. Your software provider needs to be able to see the road ahead, cope with the bumps today and get ready for what’s around the corner tomorrow. Mark Davison, an EU based serialization expert for rfxcel, discusses the importance of an implementation plan in serialization and full support from track and trace vendors (learn more rfxcel Implementation Serialization Plan). Mark has been in the biotech and Pharma industry for more than 10 years and has witnessed the legal changes in the external environment regarding serialization, track and trace and pharmaceutical supply chain regulations.

The industry evolved from 10 years ago where there were multiple different suggestions, different legal initiatives and different philosophies of how to trace product through the e-pedigree years. Companies theorized  50 plus solutions to providing a safer supply chain. Currently, there are industry standards that guide the Pharmaceutical industry in regards to implementation and serialization, track and trace systems. The tools and products have evolved to become compatible across different markets that have implemented these standards.

Nevertheless, there are still significant geographical requirements, variations, deadlines, and changes that affect how a company does business. It is important to choose a solution provider that understands these standards and can integrate your supply chain to the appropriate markets. Companies should ask about the implementation plan in serialization and show documentation on the process.

Not only do companies need a solution provider to understand the industry but they must be experts in navigating the changes as the market evolves. History has show the complexity and dynamicity of the industry that requires companies to do much more than simply connect to a hub. rfxcel is a solution provider that will be the backbone of your company IT and serialization department. We ensure the needs of a business are fully supported by a compatible and flexible system.

rfxcel is the solution provider that has been in the serialization and track and trace industry the longest and has a team of subject matter experts. Most importantly we are here to help you with this complex system and take the burden off so you can focus on the things you enjoy doing.


Data Matters in Serialization (Part 2 of 6) – Single vs Multi Tenant Systems in Serialization

Serialization experts often get asked to clarify the difference between Single vs Multi Tenant Systems in Serialization solution providers and why should companies invest in one system over another. Mark Davison, EU based serialization expert, discusses, Single vs Multi Tenant Systems in Serialization, the differentiators between serialization and track and trace solution providers.

To make a truly informed decision about solution providers, companies need to understand and plan out their requirements from the beginning. For example, Pharmaceutical companies need to ensure that the solution they purchase is validated with EU Annex 11 and 21 CFR part 11 for the the U.S. Drug Supply Chain Security Act (DSCSA) or the E.U. Falsified Medicines Directive (FMD) respectively. Pharmaceutical companies must also ask whether their suppliers can validate their system and ensure compliance. Companies need to ask solution providers; how will they ensure to be compliant? Do they follow industry standards? Is the system stable in the long run? Will they be there to support and carry the validation burden?

Typically, these systems will boil down to two different options for a solution provider to host and manage your system:

  1. A single tenant system which is under a private cloud where there is a single product instance that companies control and decide when and how it is updated. This also allows the company to customize its features according to its requirements and needs.
  2. A multi-tenant system which is under a public cloud infrastructure, where a company shares the environment with other companies and the solution provider decides when that environment is updated and patched. Companies don’t have any control over when to accept product changes and updates. Meaning the system can be down at any moment and without any backup.

From our experience here at rfxcel, validation engineers in the pharmaceutical serialization and track and trace industry want to control the environment quite tightly.  So having the choice of how and when to do that is very important for your journey to meeting compliance requirements.

Here at rfxcel, we believe that the customer should be in control. They should have the ability to decide how to lock down the system, and when to to make and document changes. This is important because in the end, it will be up to them to prove to the regulators who, when and how they do business. And with total control over the data, companies can pull the needed information for audit.

Think of what hoops your company has to jump through with regulators to make sure you get what you need out of the system to ensure patient safety and maintain data integrity.


Data Matters in Serialization (Part 1 of 6) – Value Beyond Compliance

Mark Davison, EU based serialization expert for rfxcel, discusses serialization and added value beyond compliance in the pharmaceutical industry. He has been in the pharmaceutical serialization and track and trace industry for over 10 years and has seen serialization evolve in the pharmaceuticals supply chain. After all these years, companies are discovering the added value beyond compliance of certain implementations and certain serialization software solutions over others.

He provides insights regarding compliance and serialization programs for complying with the law and the specific jurisdictions in the E.U. Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA). The discussion focuses on added value beyond compliance, business benefits and using data beyond compliance.

Let’s start by focusing on the basic question such as, What does serialization actually mean?
Many companies believe all they need to do is add a unique identifier to products to comply with the regulations. Serialization seems simple, but beneath the process, things get difficult. Complexity and depth start when integrating trading partners. However, intelligent integration with the help of an experienced serialization solution provider can reduce business risk, magnify supply chain visibility and business value.

Further, products in supply chain change different ownership. Thus, brand owners need to manage the data that is associated with that unique entity. The difficulty continues with verifying data for full integrity as it passes through different ownership. This is why you need to think very carefully about who you trust to manage these risks on your behalf and who your serialization solution provider needs to be.

Ensuring products stay accurate in the supply chain should be your main priority. The FDA and other global regulatory bodies are emphasizing the importance of accurate and reliable data in ensuring drug safety and quality. With the increase of the pharmaceutical supply chain resolution comes a big risk of bad data. At rfxcel, we ensure every event is checked and verified for you to avoid these issues in today and in the tomorrow.

Mark touches how rfxcel’s track and trace solution focuses on data processing to achieve data accuracy.