September 2017 - Page 2 of 2 -

Understanding Pharmaceutical Serialization Track and Trace: Enhancing Visibility and Safety

Serialization is the process of assigning predetermined codes to each unit or container of medication you manufacture. The code or serial number assigns each product item a digital identity, which you can track and trace as it progresses throughout the supply chain. Pharmaceutical serialization is a common type which is used to track and trace and provide supply chain visibility for pharmaceutical drugs.

When designing a codification system, you can make your serialization codes as detailed as government regulations necessitate.

Additionally, you can incorporate information like the date of production, when and where the item was manufactured, a lot or batch number, the stock-keeping unit (SKU), a drug or product description, and the manufacturer’s Global Trade Identification Number (GTIN).

Leading solutions also provide built-in code structure flexibility that can accommodate customized application identifiers (AIs). GS1, the internationally-recognized system of standards, created a dynamic definition of AIs that gives you the freedom to include a wealth of information in your code.

Now that we’ve addressed the question, “What is serialization,” let’s examine why it’s important to the pharmaceutical industry and how you can tap into significant organizational benefits by adopting modern serialization software.

What Is Pharmaceutical Serialization?

To adequately define serialization, we must not only consider the meaning of the term but also discuss why serializing products is a critical business management process.

Over the last several years, regulatory entities such as the European Medicine Agency (EMA) and the U.S. Food and Drug Administration (USFDA) have implemented significant changes to pharmaceutical regulations.

Why Is Serialization Important in the Pharmaceutical Industry?

The FDA’s Drug Supply Chain Security Act (DSCSA) is the most notable of these changes. While the DSCSA was passed in 2013, its final phase of provisions will come into force in late 2023. Among other things, this act requires that pharmaceutical products be serialized to promote traceability and preserve product integrity.

Serialization techniques may vary slightly from one nation to another. However, all labels will include some basic product information, regardless of the country of origin. 

For instance, a product label will typically include the following:

  • A unique serial number
  • A batch number
  • An expiration date
  • An identification code

Performing pharmaceutical serialization reduces the risks of harm associated with counterfeit medicines seeping into the market. Additionally, serializing medications allows regulatory authorities to hold violators accountable, preserve the integrity of the pharmacological supply chain, and protect consumers.

From your organization’s perspective, pharmaceutical serialization plays an important role in compliance. The aforementioned laws impose harsh penalties on entities that fail to comply with labeling and serialization requirements.

Looking Beyond Compliance: The Benefits of Pharmaceutical Serialization

Now that we’ve answered the question, “What does serialization mean” and touched on the growing importance of this tracking and identification method, let’s shift our attention to the benefits of implementing a serialization strategy.

Pharmaceutical serialization is an effective way of ensuring adherence to regulatory requirements and safety guidelines. Countless entities within the pharmaceutical space use serialization software for data validation and compliance purposes.

That said, compliance is just one benefit of pharmaceutical serialization. It can also assist with the following:

Supply Chain Visibility

The pharmacological supply and distribution network is one of the most complex in existence. Historically, this complexity has made achieving end-to-end supply chain visibility difficult.

While pharmaceutical serialization won’t entirely solve the industry’s visibility problem, it will certainly have a big impact on overall supply chain transparency. By equipping products with unique identifiers, manufacturers can track materials, ingredients, and finished products as they progress through the supply chain. 

Serialization enables manufacturers to closely manage their logistics processes. They can use these insights to pinpoint potential bottlenecks, increase supply chain efficiency, and ensure the timely delivery of goods to consumers.

Combating Counterfeiting

According to the Centers for Disease Control (CDC), approximately 9%–41% of medicinal products sold in low-to-mid-income nations are counterfeit.

Comparatively, less than 1% of pharmaceutical products sold in the U.S. are counterfeit. The FDA’s stringent labeling and serialization requirements are a major reason why counterfeit medicines aren’t a major issue in the U.S.

Expanding pharmaceutical serialization standards can help combat counterfeiting in less-developed low-income countries. Putting a stop to the distribution and sale of fraudulent products will also enable manufacturers to preserve their reputations in international markets.

Serialization gives retailers, distributors, and end users a means of discerning whether products are part of a legitimate batch of medication. Scannable codes are a particularly convenient and useful authentication tool, as they’re difficult for counterfeiters to fake.

Coordinating Product Recalls

Despite a manufacturer’s best efforts, medical devices and drugs sometimes must be recalled and taken out of circulation. Without an effective pharmaceutical serialization strategy in place, manufacturers must cast a wide net. This leads to significant waste, as safe, effective products are recalled and disposed of.

Properly executed pharmaceutical serialization helps manufacturers determine precisely which batches were impacted so they can reduce waste and limit the scope of recalls. Serialization and labeling also enable manufacturers to coordinate with government agencies to maximize the efficiency of recall efforts.

Monitoring Consumption Rates

Through serialization and labeling, manufacturers can track products from the factory to the point of consumption. They can leverage these insights to monitor each batch, examine consumption volume, and keep up with demand.

As demand wanes, manufacturers can adjust accordingly to preserve liquidity and avoid over-ordering raw materials. If consumer demand spikes suddenly, the manufacturer can scale production back up to prevent shortages and ensure that patients have access to essential medications.

Challenges to Serialization

As you can see, pharmaceutical serialization is a critical component of compliance. This process also has an impact on client satisfaction, patient safety, and your organization’s profitability.

Efficient serialization processes will enable you to adapt effectively to fluctuating consumer demand, protect your brand image, and optimize supply chain visibility. However, before you can unlock the benefits of pharmaceutical serialization, you must first overcome several challenges, including the following.


Data aggregation is key to promoting traceability and supporting the steady flow of goods across the pharmaceutical supply chain. Aggregation is the process of consolidating information from each participant in your supply chain into a unified, secure, and accessible database.

Let’s say your organization is the third link in the supply chain. The first is the raw material supplier, and the second is the carrier that delivers those materials to your facility.

When you receive the materials, you must assimilate the information from the supplier and carrier into your database. You also need to supplement this information with your own data.


Facing a rapidly approaching deadline can lead to a mad dash to modernize your pharmaceutical serialization protocols. Feeling the pressure of these deadlines will speed up your adoption process, right? Yes and no.

While you may be able to quickly adopt some new technology, waiting until the last minute can cause you to overlook essential steps during implementation. As a result, you’ll have to backtrack to fix gaps in your serialization strategy.

If you haven’t already begun implementing pharmaceutical serialization technology and processes, now is the time to start.


Aggregating data will help you track and serialize whole boxes and pallets of products. But what happens if a customer needs a partial pallet or box? While you could raise your minimum order quantities (MOQ) to prevent this, doing so can deter purchases and negatively impact your sales volume.

When designing your serialization process, include an integrated repack phase so you can offer partial orders. When a picker scans the item serial numbers, the solution will repack the numbers and assign product data to the appropriate pallet or box.


While you may already have serialization software, that platform likely lacks the scalability and flexibility of more modern solutions. As a result, you may not have the technological infrastructure necessary to support efficient pharmaceutical serialization.

The good news is the solution to this hurdle is relatively simple: replace your aging legacy technology with the world’s most scalable and robust serialization software from rfxcel.

Our leading-edge, flexible serialization solution can help you meet today’s labeling requirements and prepare for the unexpected regulatory challenges of tomorrow. Rfxcel not only provides you with dynamic software but also assists with the implementation process so you can maximize your ROI while minimizing the procedural hassle.

Expedite Your Serialization Implementation Process with rfxcel

With the final phase of the DSCSA rollout rapidly approaching, your organization must ensure that it has the right serialization software to support its compliance. Otherwise, you’ll find yourself struggling to meet the stringent requirements of the FDA’s latest drug safety and traceability provisions.

Serialization isn’t just crucial for pharmaceutical compliance. It also influences patient safety. By engaging in serialization, you can prevent bad actors from perpetrating your supply line and releasing illegitimate medications under your brand name.

Fraudulent activities endanger consumers and threaten your organization’s reputation. Fortunately, you can protect consumers, preserve your brand image, and ensure compliance with the DSCSA by partnering with a forward-thinking serialization software provider like rfxcel.

We offer a variety of labeling, tracing, and serialization solutions designed to meet the unique needs of the pharmaceutical sector. 

Contact rfxcel today to learn more about our suite of solutions.

Traceability in HDA

rfxcel has been a member of the Healthcare Distribution Alliance (HDA) post the enactment of the Drug Supply Chain Security Act (DSCSA) in 2013. The law nulled all previous pedigree requirements to unify track and trace requirements of prescription medications distributed throughout the United States.

HDA represents 34 distribution companies, 145 manufacturer and 50 service providers in the US and International markets. Partnering with HDA means connecting with more than 200,000 licensed health care providers . However, It is not the size of the organization that matters, it is the mission.

Since 1876, HDA has been working to protect patient safety through securing the supply chain and advocating for public policies and business processes. The healthcare supply chain already relies on rfxcel for secure serialization, data management, and reporting, so partnering with HDA to deliver an industry ecosystem is well aligned with our expertise and strategic vision. HDA has been essential in providing a network of industry leaders to partner with. rfxcel understood early on that partnering with others would add value to the company as well as its customers.


DSCSA objectives:

  • Establish unit-level traceability requirements for the entire supply chain with 10 years  
  • Issue standards across states and enhance federal & state authority to issue licenses
  • Initiate processes for identifying suspicious and illegitimate products

rfxcel objectives:

  • Promptly solve current and imminent supply chain business demands
  • Support open collaboration within the supply chain ecosystem
  • Adapt to customers and their business processes
  • Provide a complete compliance solution for the supply chain

HDA recently completed a pilot study to examine different methods of verifying product identifiers for distributors and manufacturers in the supply chain. The close partnership with HDA and technical advancement is helping rfxcel to conduct and understand the technologies and processes required to implement future DSCSA requirements. rfxcel customers will always be ready to meet compliance today and tomorrow.

rfxcel continues to support the HDA. rfXcel will be at the 2017 HDA Education: Traceability Seminar November 8-10, 2017 in Renaissance Washington, DC where rfXcel will be sponsoring and exhibiting.

rfxcel Raises $30 Million in Series B Financing

San Ramon, CA, August 3, 2017  rfXcel, the leader in Track and Trace and regulatory compliance solutions, today announces it has raised $30 million in a round of funding led by Kayne Partners. Kayne Partners is the growth private equity group of Kayne Anderson Capital Advisors, L.P., an alternative investment firm managing over $25 billion in assets.


rfXcel plans to use this investment to accelerate the delivery of innovative supply chain solutions; increase resources to extend its successful Internet of Things (“IoT”) partnership with Verizon; and expand its global geographical presence in the Americas, Europe, Middle East and Asia Pacific. Founded in 2003, rfXcel has been providing mission-critical solutions to life sciences customers longer than any provider in this space. Because of its tenure and commitment to innovation, rfXcel offers the most feature-rich solution and flexible platform in the market.


rfXcel offers customers a long-term strategic solution to gain insight and visibility into their supply chains,” said Leon Chen, Managing Director of Kayne Partners, who will join rfXcel’s board of directors as part of this financing. “rfXcel has developed a track record of building great technology and partnering with customers in life sciences and other industries to build strong business relationships and solve complex challenges.”


We are excited to team with Kayne Partners,” said Glenn Abood, Co-Founder and CEO of rfXcel. “rfXcel has the longest track record in meeting the supply chain visibility and regulatory needs in the life sciences industry. This partnership allows rfXcel to accelerate its market growth and extend its leading edge technology. With the accelerated changes in technology and shifting market needs, rfXcel will continue to lead the industry with its technology platform and laser focus on customer success. Our mission is to protect patients and combat the illegal counterfeit pharmaceutical market and this capital provides us with the means to broaden our reach in this battle.”


About rfXcel:
rfXcel is the leading provider of SaaS based track and trace solutions that enables customers to protect patients and meet their compliance needs while getting insights and visibility into their supply chain. Its relentless commitment to customer success and continuous innovation ensures that customers meet their requirements and protect those who depend on them.


About Kayne Partners

Kayne Partners is a leading provider of capital and connections to rapidly growing companies in North America. Since its inception more than a decade ago, it has invested over $600 million in platform investments and add-on acquisitions. Kayne Partners seeks to partner with driven entrepreneurs as a non-control minority investor and provide transformative capital to these high growth companies. Kayne Partners is the growth private equity group of Kayne Anderson Capital Advisors, L.P.

For more information, visit


About Kayne Anderson Capital Advisors, L.P.

Kayne Anderson Capital Advisors, L.P., founded in 1984, is a leading alternative investment management firm focused on niche investing in upstream oil and gas companies, energy and infrastructure, specialized real estate, growth equity and both private credit and diversified liquid credit. Kayne Anderson manages over $25 billion in assets and employs over 300 professionals in eight offices across the U.S.

Kayne Anderson is headquartered in Los Angeles with offices in Houston, New York City, Chicago, Denver, Dallas, Atlanta and Boca Raton.

For more information, visit



Kayne Partners:
Leon Chen, Managing Director
310.282.2834 or

Herb Wong, Head of Marketing
925.791.3235 or

rfxcel Names Brian Bilyeu Vice President of Sales

San Ramon, CA, January 4, 2017- rfxcel, the leader in serialization, traceability, and DSCSA and global compliance for the Pharmaceutical and Life Sciences industries, today announced the promotion of Brian Bilyeu to Vice President of Sales. Mr. Bilyeu joined rfXcel in 2015 during that time he has been instrumental in contributing to the company’s unprecedented growth within the pharmaceutical industry. As Vice President of Sales, Bilyeu will be responsible for leading rfXcel’s sales team and developing new business opportunities both domestically and globally. Mr. Bilyeu brings over 30 years of leadership experience in sales & sales management, supply chain operations and IT leadership.

“I am looking forward to this expanded role and continuing to be part of an innovative organization that maintains its success by focusing on the needs of customers,” said Brian Bilyeu.

“Brian’s promotion is well-deserved recognition of the role he has played in the development and exponential growth of key accounts,” said Glenn Abood, Founder and CEO of rfXcel. “Brian’s leadership and experience make him ideally suited to lead our sales force and the continued growth in our core vertical markets.”

About rfXcel:
rfXcel Corporation, headquartered in San Ramon, CA is a leader in improving the safety, quality, and security throughout the Life Sciences supply chain. rfXcel provides supply chain product traceability that reduces operating costs, increases revenue and significantly decreases the potential introduction of counterfeit drugs. Our private cloud-based rfXcel Traceability System (rTS) is an easy to use solution that provides timely, accurate supply chain tracing information and requires no upfront data manipulation to implement. Unlike other solutions, rTS validates your tracking data and our private cloud solution eliminates the need for re-validation, you choose when to upgrade. Compliant with DSCSA and global government regulations, you will have complete visibility and traceability through your supply chain. Partner with rfXcel to access the most flexible, feature-rich traceability solution available today.

rfxcel, Be4ward to Hold DSCSA Serialization Webinar for CMOs

San Ramon, CA November 2, 2016 – rfXcel and Be4ward announce that they will co-host an informative webinar on November 16, 2016 for Contract Manufactures. This session will help clarify some of the confusion Contract Manufactures are facing when it comes to meeting the DSCSA requirements by November 17, 2017. The webinar will address the key areas of the law that must be met, practices to incorporate, what trading partners are looking for, and how you can accelerate compliance while creating value for your company.

The session will be co-presented with Stephen McIndoe, VP and serialization expert at Be4ward. Stephen will show how to accelerate the process to meet the fast approaching DSCSA deadline.

“There are many issues to master in preparing for DSCSA serialization deadlines”, said Glenn Abood, Founder and CEO of rfXcel. “rfXcel has helped a range of providers meet their serialization requirements with seamless integration on our private cloud network that was built from the outset for maximum speed and scalability. With the ability to integrate with any ERP system without the need for middleware platforms we can help CMO’s meet the November 2017 deadline. With database normalization and validation we reduce data redundancy and improve integrity while connecting you to your trading partners with ease.”

Don’t be left behind, register today for this informative webinar at: or


About rfXcel:

rfXcel Corporation, headquartered in San Ramon, CA is a leader in improving the safety, quality, and security throughout the Life Sciences supply chain. rfXcel provides supply chain product traceability that reduces operating costs, increases revenue and significantly decreases the potential introduction of counterfeit drugs.  Our private cloud-based rfXcel Traceability System (rTS) is an easy to use solution that provides timely, accurate supply chain tracing information and requires no upfront data manipulation to implement.  Unlike other solutions, rTS validates your tracking data and our private cloud solution eliminates the need for re-validation, you choose when to upgrade. Compliant with DSCSA and global government regulations, you will have complete visibility and traceability through your supply chain. Partner with rfXcel to access the most flexible, feature-rich traceability solution available today.


About Be4ward:

Be4ward is a niche consultancy company helping pharmaceutical, biotech and medical device companies and their supply base improve their serialization, labeling and artwork capabilities. Be4ward help clients define the most efficient business processes, organization design and, being completely independent, help them select and implement the most appropriate service providers and IT systems to meet their needs. If you would like more information about this topic, please contact Stephen McIndoe on email at Corporate website:

rfxcel to Deliver DSCSA Compliance Solution to Premier Inc.

rfXcel SNAP product will be made available to all Premier members at preferred pricing

San Ramon, CA, July 26, 2016 – rfxcel, the leader in serialization, traceability, and DSCSA and global compliance for the Pharmaceutical and Life Sciences industries, today announced it has reached a new group purchasing agreement with Premier Inc., a leading healthcare improvement company. Under the agreement, rfXcel will offer rfXcel SNAP, its DSCSA compliance software solution specifically for dispensers, to Premier acute care, continuum of care and REACH™ members at pre-negotiated and preferred pricing and terms.

Premier, which operates a national group purchasing organization (GPO), enables better care and outcomes at a lower cost for its approximately 3,600 U.S. hospitals and 120,000 other providers. rfXcel SNAP is the easiest and most automated compliance management solution for pharmaceutical dispensers to comply with DSCSA regulations. The application is designed to make it simple, easy and fast to receive and enter product information from manufacturers and/or wholesalers and distributors. Premier members have the opportunity to join thousands of other dispensers across the US in using rfXcel SNAP to help them comply with DSCSA dispenser regulations and gain peace of mind.

“We’re pleased Premier members have selected rfXcel SNAP as a recommended DSCSA compliance solution for the Premier alliance. rfXcel SNAP is already bringing value to thousands of dispensers, and our agreement with Premier further demonstrates our dedication and commitment to helping pharmaceutical dispensers become DSCSA compliant and ultimately helping to ensure patient safety,” commented Glenn Abood, Founder and CEO of rfXcel. “We look forward to helping Premier deliver on its mission of enabling better care and outcomes at a lower cost for its members.”

About rfxcel

rfXcel Corporation, headquartered in San Ramon, CA, is a pioneer in creating Product Serialization, Traceability and Compliance private cloud solutions for the Life Sciences industry. Leading manufacturers, distributors, packagers, dispensers and retailers leverage rfXcel solutions to meet global government regulations, track and trace product throughout supply chains, and enhance patient safety.



Jack Tarkoff

rfxcel Corp.