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Falsified Medicine Directive: What makes rfxcel different?

What are the serialization and compliance needs in Europe and how can rfxcel help with Falsified Medicine Directive?

There is a huge need globally for serialization and associated services, particularly for Pharmaceutical companies in Europe. There are several thousands of Pharmaceutical companies in Europe that have to get ready for a tight deadline on February 9, 2019. This deadline is right around the corner and Pharmaceutical companies need professional service providers that will get this job done right and on time.

People in the industry, recognize rfxcel as one of those companies that can get that job done. Pharmaceutical companies need, reliability, dependability and technical excellence to get them ready for their obligations. The Falsified Medicines Directive (FMD), it is different than the Drug Supply Chain Security Act (DSCSA) and it contains a number of wrinkles, bits and pieces, data requirements that people need to get ready for. Pharmaceutical companies need to have a system that can cope with a spectrum of requirements.

If a US Manufacturer with a built-in serialization compliance formatted with US DQSA, is it also set to go in in the European Market?

Europe is different in the sense that the overlying data architecture is similar, it is a GS1 based data framework that his being used so global trade out serial numbers, lot numbers, expiry etc. However, the big differences in the FMD are in which the data is captured. In the US it is transaction by transaction and it builds up over time. In Europe, with some exceptions, the manufacturers upload the data when they create serial numbers and the pharmacist verifies that number is true and they dispense the product. The in-between supply chain is not universally checked as it is in the US. In some case it is checked but every transaction like in the United States.

The second major difference; in Europe manufacturers have to make their products tamper evident. The Drugs Supply Chain Security Act (DSCSA) is silent on the physical packaging. However, in Europe the box has to be sealed and ensure it stays closed.

About Glenn Abood: Abood is the CEO and founder of rfxcel. He has been providing track and trace solutions for the Pharmaceutical industry in US, Europe, India, Brazil  for over 13 years. Glenn focuses on building a company with industry leaders and experts  including, Mark Davison.

About Mark Davison: Davison is a serialization and track and trace expert in the European market with over 15 years experience bringing solutions to the Pharmaceutical industry.

How can a sensor the size of a nickel help stop food poisoning? rfxcel and Verizon’s advanced Environmental Technology helps proactively monitor the supply chain; keeping the food safe.

For any food provider, the quality of their product is of the utmost importance to stop food poisoning. Fish industries, such as Organic Oceans, are seriously affected by the conditions in which their products are handled and shipped to their clients. The moment the fish gets out of the water, it’s a race against time. Bacteria can multiply to high enough levels that cooking it could not destroy all of them. Research shows that 3,000 Americans die each year from food-borne diseases and 128,000 people hospitalized. It is therefore essential for food providers, such as Organic Oceans, to control the environmental conditions in which their product is delivered to the consumers. To provide top quality fish, it is essential for the fish to stay in an unbroken cold chain (a temperature-controlled supply chain). Sometimes the product arrives and the cold chain has been interrupted. It is essential to identify where in the cold chain that occurred. The Environmental Monitoring Technology helps these food industries to have control over the entire delivery process hence ensuring the client gets the product in excellent condition. Food has to be fresh. It’s that simple.

rfxcel and Verizon developed an advanced environmental monitoring system based on IoT technology to track environmental conditions in real-time. A nickel-sized sensor can securely track the product and measure everything from changes in temperature to humidity. It enables companies to monitor and protect anything they ship and ensures that the shipped and delivered product has the same top quality. Who would think that such a tiny sensor could help keep the food chain safe?

About rfxcel Environmental Monitoring (IoT) Software:
rfxcel has developed the Environmental Monitoring Software which provides a rich set of over thirteen (13) monitoring capabilities or sensors to track a diverse set of industry needs. Examples of this include not only temperature monitoring but also Geo-Fencing to ensure that shipments do not deviate from predetermined routes or shipping/receiving locations. Sensor capabilities such as Device Jamming to detect if the signal is being intentionally blocked as the first step to diversion. Also, Light Monitoring (for visible and invisible light waves) to ensure that a sealed container is not opened until it arrives at the point of destination. rfxcel continuously monitors incoming data to ensure data quality with the mission to give organizations real-time insights into their supply chain process. The software sends real-time notification if a problem occurs so customers can act immediately.

For more information about the Environmental Monitoring Software please visit here or book a quick 30 min demo.

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.

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 Software) with 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.

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 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.

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.

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.