August 2019 - rfxcel.com
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rfxcel Continues Rapid Growth, Success in Russia

August 28, 2019. rfxcel, the global leader in supply chain track and trace solutions, today announced that it had doubled the size of its workforce in Russia and was pursuing deals in new industries, continuing its rapid growth in one of the world’s most important markets.

The new Russian staff joining rfxcel’s Moscow-based operations bring expertise in key areas of supply chain management and technology. Their experience includes project management and purchasing in the international automotive supply chain, telecommunications, liaising with developers and engineers to ensure they understand and meet customer requirements, business development, technical project administration and coordination, and customer training.

They build upon rfxcel’s established team of supply chain experts in Russia, led by General Director Victoria Kozlova. Ms. Kozlova manages the implementation of rfxcel’s robust track and trace solutions for the life sciences. She has almost two decades of experience in pharmaceutical and consumer goods supply chain management.

With the addition of this staff, rfxcel is poised to continue its expansion into other industries, most notably retail and branded goods. The company is currently in talks with a U.S.-based multinational branded clothing and footwear corporation to track its products from warehouses in the EU to points of sale in Russia. Other industries rfxcel is pursuing include food and beverage, luxury goods, and consumer goods.

rfxcel entered the Russian market with a roster of clients in the pharmaceutical industry. The longest-tenured supply chain track and trace solution provider in the life sciences, rfxcel is one of few providers with implementations in Russia. It is helping companies meet the country’s complex regulatory requirements, including strict serialization guidelines that will go into effect on January 1, 2020. Russia’s pharmaceutical market is expected to reach $38 billion by 2021.

“This is a very exciting time for us,” rfxcel CEO Glenn Abood said. “We have been committed to growing our presence in Russia, and things are really taking off. Doubling the size of our team, especially with such talented and experienced people, will make us nimbler, expand our geographic reach, and give us entrée to new markets and customers. We’ve made a name for ourselves in Russian pharma and compliance; we’re ready to take those successes and build on them in retail branded goods and other industries that can benefit from our proven supply chain technologies.”

To learn more about rfxcel’s growth in Russia or its innovative track and trace solutions, contact Vice President of Marketing Herb Wong or visit rfxcel.com.

Herb Wong, VP of Marketing

hwong@rfxcel.com

925-824-0300

 

About rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. The company is headquartered in the United States and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

Saudi Food and Drug Authority : A Quick Guide to Saudi Arabia’s Pharma Regulations

Saudi Arabia is the first of the six countries in the Gulf Cooperation Council to require drug traceability. Initiated by the Saudi Food and Drug Authority (SFDA), the Drug Track and Trace System (RDS) tracks all human registered drugs that are manufactured in Saudi Arabia or imported to the country.

SFDA is charged with ensuring the safety of human and veterinary drugs. It also oversees biological substances, chemicals, and electronic products. It has three primary objectives: preventing counterfeit drugs, improving drug availability, and achieving drug safety. To meet these goals, it is working to monitor all supply chain operations, gather reliable data about commonly counterfeited drugs, and utilizing technology (e.g., smartphones) so patients can get information about medications and receive real-time notifications about recalled drugs or similar warnings.

RDS is a standardized identification system that tracks drugs from the manufacturer to the patient. It adopts GS1 standards and applies to all pharmaceutical products on the Saudi market, including over-the-counter (OTC) medicines. According to GS1, Saudi Food and Drug Authority (SFDA) is working on similar requirements for medical devices and cosmetics.

Saudi regulations stipulate that all drugs must be marked with a GS1 Data Matrix barcode that contains, at minimum, the GS1 Global Trade Identification Number (GTIN), the expiry date, and the batch/lot number. This information must also be printed on labels. All transactions for drug packages must be reported to a national Drug Track & Trace System (DTTS), and all manufacturers licensed by the SFDA must acquire a Global Location Number (GLN).

Every registered drug in the Saudi market is assigned a Saudi Drug Code (SDC) that contains four variables: a fixed prefix, the year, a letter to identify the type of drug, and a serial number (e.g., SFDA12D001). The SDC will eventually replace the current code.

Furthermore, Saudi Food and Drug Authority will require products to be aggregated beginning October 1, 2019. All individual saleable units must be linked to the case they’re shipped in.

The SFDA and SDC requirements are complex and will be challenging for an array of stakeholders, including manufacturers, warehouses, and pharmacies. The aggregation requirement is particularly pressing, especially for companies that have not begun to prepare for the October deadline. To comply with the aggregation regulations, they’ll have to ensure their packaging lines are prepared, coordinate with trading partners, and have systems that can capture and report data to the DTTS.

rfxcel is ready to help your company comply with all Saudi regulations. We’re cultivating a presence in the region, including being an exhibitor at this year’s CPhI Middle East & Africa (MEA) conference in Abu Dhabi, United Arab Emirates. Our Traceability Platform (rTS) can help you keep track of all the products in your supply chain and ensure you’re complying with all SFDA and SDC requirements — or regulations in any country. Contact us for more information. Our supply chain experts are ready to help!

Saudi Food & Drug Authority

 

 

rfxcel to Exhibit at CPhI Middle East & Africa in UAE

rfxcel, the global leader in supply chain track and trace solutions, will exhibit at this year’s CPhI Middle East & Africa (MEA) conference in Abu Dhabi, United Arab Emirates. The company is cultivating business in the region, particularly pertaining to new serialization requirements from the Saudi Food and Drug Authority (SFDA).

More than 4,900 suppliers and buyers from across the worldwide pharma supply chain are scheduled to attend CPhI Middle East & Africa, which will be held September 16–18 at Abu Dhabi’s National Exhibition Centre. The annual event is a chance for pharma professionals to network and see the latest in pharmaceutical technology.

“rfxcel is going to CPhI Middle East & Africa for several reasons,” rfxcel CEO Glenn Abood said. “Of course, we’re excited to meet people and let them know about our innovative track and trace and compliance solutions. But we also want the industry to know we’re serious about working in the region and have proven technology to meet serialization requirements there, in Saudi Arabia, for example.”

The SFDA initiated a Drug Track and Trace System (RDS) to track both imported human registered drugs and those made in Saudi Arabia. The system adopts GS1 standards and applies to all pharmaceutical products on the Saudi market, including over-the-counter (OTC) medicines. All drugs must be marked with a GS1 Data Matrix barcode that contains, at minimum, the GS1 Global Trade Identification Number (GTIN), the expiry date, and the batch/lot number. This information must also be printed on labels. All transactions for drug packages must be reported to a national Drug Track & Trace System (DTTS), and all manufacturers licensed by the SFDA must acquire a Global Location Number (GLN).

Furthermore, every registered drug in the Saudi market will be assigned a Saudi Drug Code (SDC) that contains four variables: a fixed prefix, the year, a letter to identify the type of drug, and a serial number (e.g., SFDA12D001). The SDC will eventually replace the current code.

“The SFDA and SDC requirements are complex and will be challenging for pharma companies,” Abood said. “But rfxcel has experience around the world — in Russia, India, China, Brazil, the EU, and the United States — and has unrivalled track and trace and compliance capabilities that we want to bring to Saudi Arabia and other MEA countries. An array of stakeholders will be affected by the Saudi regulations. We want them to know rfxcel has the powerful solutions they need to be compliant.”

For more information on how rfxcel can help your company comply with the Saudi regulations or to learn more about rfxcel’s track and trace and compliance solutions generally, contact Vice President of Marketing Herb Wong or visit rfxcel.com.

 

Herb Wong, VP of Marketing

hwong@rfxcel.com

925-824-0300

 

About rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. The company is headquartered in the United States and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

rfxcel VRS Pilot for the Food and Drug Administration

rfxcel kicked off its FDA-approved Verification Router Service VRS pilot in June. The pilot is designed to quantify the readiness of the VRS network to meet the Saleable Returns Requirement of the Drug Supply Chain Security Act (DSCSA), which is scheduled to take effect this November. The FDA pilot builds on the VRS efforts of the Healthcare Distribution Alliance (HDA) and will systematically verify, measure, and report on the ability of the VRS network to meet the functional requirements of VRS.

As part of this effort, rfxcel has begun publishing its detailed VRS test cases with stakeholders, including VRS providers, manufacturers, and wholesale distributors. Although rfxcel initiated this effort, it is too important to belong to any one participant, and we are greatly encouraged by others in the pharmaceutical supply chain that have volunteered to participate in the pilot. For example:

  • Improved testing: Another VRS provider reviewed rfxcel’s testing approach and provided guidance to improve the approach and metrics.
  • Scanned barcodes: One of the Big 3 asked if barcode scanning could be incorporated in the pilot. An rfxcel customer offered to provide barcodes for scan testing and helped develop a testing approach.
  • Independent audit: A consulting firm volunteered to provide resources to review and audit the results of rfxcel’s testing to ensure accuracy and neutrality.
  • Improved specification: rfxcel identified a gap in the Lookup Directory (LD) synchronization specification and reviewed the findings with another VRS provider for confirmation. As a result of this effort, rfxcel will submit a joint recommendation to HDA to address the gap.

This is an amazing response, and rfxcel wants to thank the many organizations that are partnering with us to address this vital industry need. We can meet global compliance only if we’re all working together to help the pharma industry and our customers be prepared for regulations.

rfxcel will publish its VRS pilot report to the FDA, and we would love to share it with you too. If you would like to follow the progress of the pilot and all its participants, please contact us for updates about our VRS pilot.

Common Hurdles in Cargo Monitoring Logistics for Pharmaceutical Companies – and How to Clear Them

Now more than ever, ensuring the safety, quality, and timely delivery of pharmaceutical products to their final destination is a challenging and costly endeavor. With the tight regulation of supply chain systems, and the U.S. pharmaceutical market expected to grow to a value of $550 billion by 2020, pharmaceutical companies have little room for error when it comes to balancing careful cargo monitoring with reasonable cost output.

There’s no question that these companies face a number of hurdles in maintaining and tracking both the quality and the location of their cargo as it moves through the supply chain. From route and transition connectivity to en-route product quality, time-sensitive operations to environmentally-sensitive assets, real-time monitoring of cargo along the entire supply chain is more critical than ever. Fortunately, new technologies are providing solutions for those pharmaceutical providers ready to turn their supply chain problems into drivers of business success.

The Complexities of Temperature and Timekeeping

Monitoring cargo as it transitions between land, sea, and air routes is no easy feat, but ensuring that necessary conditions are maintained is a crucial part of transportation. Moving pharmaceutical products between the warehouse, suppliers, customers, and end users requires close attention to the environment in which it is being transported.

Factors such as temperature, light, tilt, and shock can all potentially damage cargo. For example, allowing drugs such as insulin to freeze and then thaw can compromise their integrity, and direct sunlight can cause irreversible damage. Considering the fact that half of all FDA drug approvals in 2017 were cold chain products, which means their transition through the supply chain requires careful temperature management, many of the drugs being transported require constant attention. In addition to this, the industry is moving towards biopharmaceutical products, such as personalized medicines and medications with high value and low volume, which have even more specific transportation needs.

So, we shouldn’t assume that keeping all drugs cold is a one-size-fits-all solution. There are new drugs on the market, including treatments for rare diseases that must be kept at body temperature.

In addition to their own strict temperature requirements, these drugs can also have shorter lifespans. They often require a different approach altogether than cold chain products, as they can’t endure the temperature spikes that may come in ambient containers. As pharmaceuticals continue to grow ever more diverse and complex, supply chain technologies must advance at the same rate to ensure quality is kept to standard.

Planning the transport of pharmaceutical goods from courier to courier also presents issues in terms of time-sensitive operations, as many products need to reach their destination within a specific timeframe to uphold their assured quality. Transitioning from different routes and modes of transport can cause delays, especially when the owner of the assets lacks real-time updates of the cargo’s location and must instead rely on shipping reports or out-of-date tracking solutions. The downside to this scenario is clear – if something goes wrong or a shipment is delayed, there is no way to immediately act accordingly.

Dated Solutions

There are available solutions to these cargo monitoring issues, but they are largely unable to provide pharmaceutical companies with the peace of mind that their goods are being kept in top condition from the beginning to the end of their journey. For example, some old sensors provide minimum visibility of goods but aren’t equipped to provide enough insight into the quality of the cargo as it passes through the supply chain. If a product were to arrive already damaged, manufacturers would only find out as a result of negative customer feedback – far too late for meaningful action.

More recently developed sensors are leaner and focus on real-time supply chain, yet they still lack effective tracking at the unit level.

With current real-time monitoring sensors, many pharmaceutical companies aren’t able to track the quality of the individual item. In the event of a problem that cannot be addressed while the cargo is en route, such as temperature fluctuations or light exposure, the whole order must be destroyed.

This is a scenario that can be entirely avoided with the use of item level sensors as part of a fully integrated serialization and real-time tracking solution. When the same situations occur – changing temperatures or inadvertent light exposure – pallets equipped with item-level sensors enable companies to track those products that have been negatively affected and those that have not. This type of monitoring drives greater efficiency, profitability, and ROI for pharmaceutical companies.

Handling and Preventing Instances of Theft

Theft of pharmaceutical products is not a new phenomenon. However, with the increase in valuation of many drugs over recent years comes a fresh need for companies to ensure that their cargo arrives safe and secure. Increasing health insurance prices coupled with a thriving black market also contributes to pharmaceutical theft, which can be hugely profitable for thieves. This is particularly urgent for sea cargo, which is on average 3.5 million tons every year, compared with 0.5 million tons transported by air.

While air travel ensures that medical cargo can make its way quickly and safely to its final destination, the numerous handling points of this cargo make it difficult to monitor closely through the entire supply chain. “There are a lot of different stakeholders that handle the cargo. Each individual partner in the supply chain has to meet the standards,” says Glenn Abood, CEO of rfxcel. “Otherwise the quality of the supply chain can be lost.” It’s this scenario that leads to annual product losses of anywhere from $2.4 to $12.5 billion – a significant amount for a market totaling $300 to $400 billion a year.

The Role of Technology

While the hurdles facing the pharmaceutical companies in their cargo monitoring efforts are abundant, technologies exist that can help alleviate these issues – and even stop them altogether. In fact, global pharma track and trace solutions are expected to reach a value of $2.38 billion by the end of 2023. It’s clearly a market that’s in high demand, and there’s no question why. These advanced solutions allow companies to combat theft and counterfeit products, while preventing damage in the supply chain.

Perhaps the most eff ective and advanced of these solutions are those using Internet of Things (IoT) technology. IoT enables data to be sent from connected products over a virtual network, thereby streamlining logistics and keeping operations moving efficiently. IoT live monitoring can give companies valuable and abundant traceable inputs, such as the temperature, tilt, shock/vibration, humidity, speed, pressure, and motion of the vehicles and the containers they’re carrying, as they move along the supply chain. These amount to real-time updates about sensitive cargo that is accessible at any point along the supply chain, with alerts and notifications delivered to smart devices that allow for preemptive action.

Embedded sensor technologies facilitate the digitization of the pharmaceutical supply chain, meaning companies can monitor their cargo closer than ever before. By digitizing their responses, companies can manage their supply and ensure better supply chain collaboration efforts both within the company and with third party logistics partners (3PLs). Real-time monitoring, which is facilitated by IoT-based solutions, means that companies can intervene immediately if they see that there is potential for damage to the product while it is en route to its destination. No longer will cargo arrive to its final destination, only for buyers to be presented with a damaged load that they cannot use.

IoT technology can also provide companies with insights at each stage of the supply chain, granting them the ability to make data driven decisions about considerations like routes and carriers. This kind of end-to-end visibility and control means pharmaceutical companies can transform the supply chain from “a cost of doing business” and a source of regulatory risk into a true business opportunity. They’ll be able to pull predictive and prescriptive data from all parts of the supply chain, conduct innovative analytics, cut costs, comply with serialization laws, and ultimately better serve their customers.

In terms of preventing theft, the use of real-time GPS sensors that track the cargo from the manufacturer to the end-user means complete visibility. In the event that packages are taken off –route or delivered to the wrong address, the asset owner is alerted immediately and so can act quickly to protect the asset. In fact, many sensors that form part of IoT technology can offer granular data in near real time. When this is coupled with unit-level tracking, companies can see the exact location and status of their units as they are being transported. It also goes without saying that a monitoring IoT device on a particular container is a powerful deterrent to any would-be thieves.

Monitoring cargo can certainly be seen as an obstacle-ridden task for many pharmaceutical companies. But the future is bright. Innovative IoT technologies make it possible for these companies to not only overcome the many hurdles inherent to supply chain transportation, but to turn previous disadvantages in their favor. These advanced solutions allow companies to keep a closer eye than ever on their goods. This kind of visibility makes it possible to protect product quality, enjoy a strong competitive advantage, create long-lasting customer relationships, increase efficiency on operations, and ultimately boost ROI.

Author Biography

Tea Rajic is a multi-faceted professional with experience in diverse industries across North America, Europe, and Asia. With a professional history in product development, design and marketing strategy across B2B and B2C sectors, Tea has been working with rfxcel to help Life Science companies meet global regulatory requirements and bring value beyond compliance.

Not Just for Pharma Anymore: rfxcel Extends Track & Trace Solutions to Food & Beverage

rfxcel recently announced that it is extending its leading-edge track and trace solutions to the food and beverage industry. The company has served the pharmaceutical industry with integrated track and trace software, and said in a release that it is now offering its solutions to offer the food and beverage industry farm to fork product visibility.

“Like pharma, the food and beverage industry is under a tremendous amount of pressure to deliver products free of contamination, adulteration, fraud, and diversion,” Glenn Abood, CEO of rfxcel, said in a release. “Their supply chain operations must be lean, reliable, and automated in such a way that the supply chain learns and adapts quickly.”

Abood said that it makes sense for the company to offer its solutions to the food and beverage industry, and that its 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. The environmental tool is award-winning and helps protect products from contamination and enables the quick identification of products for recalls.

The company said its solutions give suppliers and retailers the ability to optimize their supply chains and keep the food in their supply chains safe, as well as enable the tracking of ingredients and raw materials through to finished goods, by lot or by item.

by Kristy Nudds

Editor, Food In Canada

Three Important Factors for Selecting a Reliable Serialization Software

The WHO estimates that roughly 10% of drugs in the global marketplace are counterfeit, with levels being much higher in developing countries (30-40%).

In the U.S. alone, the FDA found that more than 50% of online drug purchases are fake. However, it’s not all bad news. Serialization solutions that can authenticate and certify medicines are making huge strides in helping eliminate these global problems.

With serialization software, pharmaceutical companies can reduce their risks and customers’ exposure to fake medicines. Serialization software minimizes the chances of product mix-ups during distribution and helps prevent the spread of counterfeit drugs. There are many benefits to the pharmaceutical industry, so how should you go about choosing the right serialization software?

There are three areas that you must consider when choosing a reliable serialization software:

First, your technical requirements, and how the vendor will meet or accommodate them; Second, the process of product implementation; Third, the people or team you will work with and their ability to be long-term partners. Take all three under consideration, and you’ll be on your way to choosing the best serialization solution for you.

Make sure the technology matches up.
Customers looking to get the best quality serialization product must be sure to look beyond the added features and prioritize the ability of the software to handle the data. Remember, features that are highlighted to sell the product can be beneficial, but the software will do you no good if it cannot handle your data.

It’s also important to check that the software offers continued data validation and verification after implementation, as well as before. Selecting a product that provides this can be hugely beneficial, as it allows for the correction of errors that may arise after implementation. Furthermore, to ensure an efficient and safe supply chain, product master data should be aligned and accurate.

Another area to research before choosing serialization software is how and where the system is maintained and hosted. Today, the vast majority of serialization software is either hosted in a public cloud or a private cloud often referred to as single or multi-tenant environments. Many serialization solutions are hosted in multi-tenant environments, which force customers to accept updates at the convenience of the vendor.

These vendors market their multi-tenant architecture as a way to get automatic software updates with little to no effort. However, be careful, this approach offers very little control to the customer and forced automatic updates often lead to chaotic end-user environments, leaving customers powerless if the update comes at a critical point in supply chain processes, which could lead to customers shutting down lines.

Finally, software providers using multi-tenant environment means that if one customer requires a new feature, then all customers get the new feature. This could be inconvenient at best and damaging at worst.

However, choosing software that operates in a private cloud or single tenant environment keeps all these problems at bay. With a single tenant architecture, you have control over your systems and your updates and can ensure your configurations remain intact.

In addition to giving you autonomy over upgrades and the addition of features, private clouds also allow you to run specific tests according to your chosen guidelines. Then, after completing the tests to make sure the upgrade is the right fit, you can install it on your terms.

Scrutinize the process as well as the product
Not only must you look in detail at the product you’re buying, but you must also prioritize the process behind the implementation. Make sure that the vendor’s team has a formal process in place to ensure they’re providing a fully validated system. It also pays to have your quality assurance team review the quality documents and process before implementation.

Without a doubt, the most critical aspect of the process is the implementation of the product. Many vendors shift this procedure to the customer, which can be extremely problematic, carrying the potential to induce significant delays. By doing this, the customer has to implement the system on their own with little consultation from the vendor should they run into any obstacles.

Companies that choose to cut costs by opting for a vendor that relieves themselves of this responsibility could end up paying for it in the long term. The time and manpower spent implementing unfamiliar software and overcoming the inevitable obstacles that come with it are considerable. While it is wise for the customer to be involved throughout implementation they should not be left holding the bag when it comes to installation.

Finally, before purchasing any serialization software carefully examine the service pricing model. It’s not uncommon for vendors to charge in relation to the length of the project.  This type of pricing model allows them to keep adding charges for ‘extras’ onto your final bill, which gives them little incentive to get it done well, quickly, and efficiently.

At rfxcel, we place tremendous importance delivering our software on time and on budget. Whether you use rfxcel or another company, consider firm fixed price contracts or time and materials. They provide more incentive for the vendor to complete implementation on time with no incentive to extend implementation.

Trust the people behind the process.
While less of a tangible box to tick, make sure that you and your vendor are on the same page. Set a clear project scope, timeline and schedule. It is crucial to work with a firm that you can trust and view as a partner, rather than one that seeks to install new software and move on. Make sure the vendor is prepared to work with you to resolve issues and is willing to be flexible to address any unexpected obstacles. Having a responsible partner that helps you find ways to solve issues that may arise, paves the way for smooth sailing on your way to serialization.

Now that you know the three most important factors when choosing serialization software -people, process and technology – you’re all set to start reviewing your serialization software options. By considering these three distinct yet equally important factors, you can be sure you’re purchasing a product that promises to serve all of your serialization needs.

Author: Vikash Pushpraj

Before joining rfxcel in 2017, Vikash spent many years successfully leading departments of product development and customer success at a number of software companies, such as PTC and Autodesk, where he was responsible for a product portfolio that generated ~$600 million annual revenue.

Vikash also has entrepreneurial experience from a number of successful start-ups and brings a renewed sense of vigour to his departments at rfxcel, often stressing the importance of time management and urgency in providing better customer service.

Company: rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. rfxcel is headquartered in the USA and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

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The digital supply chain is not just about compliance; it’s also about business value and optimization.

Implementing track and trace solutions in a dynamic environment such as India takes planning and forward-thinking precision. While the Indian government requires Indian pharmaceutical companies to comply with the Drug Authentication Verification Application (DAVA) regulation, companies are also preparing to comply with the European Union Falsified Medicines Directive (EU FMD) and the United States Drug Supply Chain Security Act (US DSCSA) for their exports. While companies are very compliance focused, it is exciting to learn about the most sophisticated technologies in the world, and how they will impact the pharmaceutical supply chain.

Starting with compliance

Many regulatory agencies, like DAVA and FMD, require manufactured prescription drugs to be serialized and uploaded into a national medicines database. India is one of the largest providers of drugs globally. Therefore, it is critical that Indian pharma meet statutory deadlines like the November 26, 2018, DSCSA and the February 9, 2019, FMD. Fail to meet these requirements and Indian pharma economy will likely suffer.

Early adoption often leads to a gain in market share. Furthermore, serialization and traceability can provide companies with the ability to know every distinct entity within their supply chain, what each product is, and its make-up. Serialization paired with innovative technologies, like Internet of Things (IoT) technology, can offer additional value beyond that of traditional track and trace software. With the help of IoT, companies can pinpoint in real-time the exact location of a product, the temperature, the various routes and handoffs, and where the product ultimately ends up. Such on-demand end-to-end visibility has critical high-value implications.

The future with Blockchain, Artificial Intelligence, and Machine Learning

Traceability companies are unlocking the benefits of technologies like blockchain, artificial intelligence (AI), and machine learning (ML) to digitize the supply chain operations.

One of the most exciting innovations in supply chain at the moment is blockchain. Traceability companies, such as rfxcel, are actively working to pilot blockchain efforts. We believe that track and trace systems provide the perfect environment to experiment with blockchain. Because blockchain is a secure immutable technology that operates through a peer-to-peer network, our solutions have established ecosystems to allow only credentialed trading partners to participate in the medicines supply chain. While the data is currently being passed via web services with AS2 or EPCIS, these regulatory ecosystems have demonstrated that there can be a trusted partner environment with clear handoffs. Once regulations are fully implemented, and the trading partner ecosystems are connected and collaborating, blockchain technology will start maturing for the pharmaceutical supply chain.

Digital supply chain is also being affected by artificial intelligence and machine learning.  Track and trace and compliance efforts have led to enormous amounts of data, too much for humans to decipher and make decisions. We’re actively working with our customers to help them implement artificial intelligence to use their data predict issues.  Paired with machine learning, systems will correct issues by making decisions without human intervention. Pharma companies will see faster and fully optimized operations, including demand forecasting, intelligent logistics, course corrections, anticipatory ordering.

Compliance – everything to gain and nothing to lose

We encourage the industry to view compliance as the key to unlocking enumerable supply chain benefits. The future beyond DAVA, DSCSA, and FMD compliance is exciting, but companies must first achieve compliance before they can get to the good stuff.  And selecting the right solution provider is the key.

 

Vikash Pushpraj is the Senior Vice President in charge for Professional Services, Cloud Operations, and Customer Success of rfxcel. Before joining rfxcel in 2017, Vikash spent many years successfully leading departments of product development and customer success at a number of Fortune 500 software companies, such as PTC and Autodesk, where he was responsible for a product portfolio that generated $600+ million annual revenue. Vikash also has entrepreneurial experience from a number of successful start-ups and brings a renewed sense of vigor at rfxcel, often stressing the importance of time management and urgency in providing overall customer success.

About rfxcel:

Founded in 2003, rfxcel is one of the first companies to focus on the safety of the pharmaceutical supply chain and bring advanced track and trace software to manufacturers, repackagers, wholesalers, distributors, and dispensers. rfxcel’s mission is to be the thought leader in traceability technology for Life Science, Food and Beverage and other industries.  rfxcel enables customers to better manage their business today and deliver value tomorrow. For more information, visit 

IoT Is the Key to Supply Chain Continuity, Visibility, and Productivity

As the global logistics and supply chain industry continues to grow — it is expected to reach $15.5 trillion by 2023 — pharmaceutical companies are facing more hurdles than ever to monitor their cargo as it passes through the supply chain.

Critical priorities include maintaining precise environmental conditions, monitoring for damage or delays, and preventing counterfeit and theft. It should come as no surprise that managing these challenges on such a massive scale requires the latest technology.

Fortunately, the Internet of Things (IoT) has the power to alleviate a lot of these supply chain issues. And the market isn’t going to slow down any time soon: Global pharma track and trace solutions are expected to reach a value of $2.38 billion by the end of 2023.

Essentially, IoT enables data to be sent in real time from connected products over a virtual network, streamlining logistics and keeping operations moving efficiently. These solutions allow companies to prevent damage and delays all along the supply chain, and combat theft and counterfeit products.

Let’s take a deeper look into why it’s in the interest of every modern pharma company to get on board with IoT technology if they want to ensure continuity, visibility, and productivity in their supply chain, and, by extension, patient safety.

Continuity
Many pharmaceutical products must reach their destination within a specific time frame to assure their integrity. Transitioning from different routes and modes of transportation can cause delays, especially if the owner of the assets lacks real-time updates of the cargo’s location and must instead rely on shipping reports from other parties or obsolete tracking solutions. The owner is forced to entrust their products to a variety of couriers, with no real way to verify the status of the shipment until it arrives at its final destination.

The implementation of IoT technology provides pharma companies with insights at each stage of the supply chain, enabling them to make real-time, data-driven decisions about routes, carriers, and other vital considerations. This allows, for example, the “smartening” of warehouses and optimization of routes.

Furthermore, IoT technology allows companies to pull predictive and prescriptive data from all parts of the supply chain, conduct innovative analytics, cut costs, ensure meeting compliance requirements, assure patient safety, and ultimately better serve their customers. Companies will enjoy greater continuity with their products arriving consistently on time and intact, resulting in satisfied buyers and an improved reputation for the sellers.

Visibility
Unit-level visibility is more essential than ever. Temperature, light, tilt, shock, and other transport variables can damage cargo. For example, light detection inside containers is an indication of product tampering or alteration, products such as insulin need to be kept at a certain temperature and out of direct sunlight, and certain cold chain shipping containers require batteries that will be compromised if they’re not kept level. In fact, nearly all 2017 FDA drug approvals were cold chain products, which require careful temperature management throughout the entire supply chain process. Many of these are treatments for new diseases, making it even more important that they are well cared for.

Not all current monitoring sensors and data loggers can track the quality of individual items in real time, meaning many pharma companies aren’t able to truly safeguard their products during shipment. In the event of a problem that cannot be addressed while the cargo is en route, such as temperature fluctuations or light exposure, the whole order must be destroyed.

However, IoT live monitoring gives companies valuable and abundant traceable inputs, such as the temperature, tilt, shock/vibration, humidity, speed, pressure, and motion of the vehicles and the containers they’re carrying as they flow through the supply chain. This means, for example, if there is a temperature excursion or inadvertent light exposure on pallets equipped with item-level sensors, companies can track those individual products that have been affected. This type of monitoring drives greater efficiency, profitability, and return on investment.

Companies utilizing IoT technology get real-time updates on the status of their cargo, including location and environmental conditions, from anywhere in the world. Accessing these updates from the comfort of a smart device, a lead technician can diagnose a problem and send the requisite information to proactively fix it, regardless of how far they might be from the shipment.

Productivity
Theft of cargo remains a major criminal undertaking and, with millions of dollars’ worth of pharmaceutical supplies being stolen each year, it’s delivering a major blow to productivity and revenues. Not only does it disrupt the supply chain, it causes huge financial losses and can affect team morale. So, with the increase in valuation of many drugs in recent years comes a fresh need for companies to ensure their cargo arrives safe, intact, and secure.

IoT technology allows companies to exercise vigilance over their assets, with enabled sensors sending advanced data in real time. Couple this with unit-level tracking, and companies can see the exact location and status of their units as they are being transported. Live GPS tracks location and can verify if drivers are doing unauthorized pickups, raising flags for potential theft activity and identifying trends on carriers and routes. If anything, unusual happens, the owner of the asset is notified and can respond in a timely manner. With the implementation of IoT technology and the resulting drop in cargo theft, pharma companies enjoy greatly increased productivity.

The often-vast distances between “Point A” and “Point B” present challenges to effectively managing cargo. For industries as large and complex as pharmaceuticals — where time, care, and security could cost millions of dollars — efficiency is key. Advanced solutions made possible by IoT technologies allow companies to keep a closer eye than ever on their products, protecting quality, creating long-lasting customer relationships, and ultimately boosting their return on investment.

Author: Glenn Abood

Glenn Abood is the Founder and CEO of rfxcel. Glenn is known for his steadfast and thoughtful approach to building rfxcel, along with being able to motivate and build relationships with everyone, leading to company success and the establishment of key partnerships and alliances in the industry. For more than 15 years, Glenn’s focus has been on creating an agile company capable of developing reliable, leading-edge traceability, which has grown to be one of the most reliable and recognizable traceability companies in North America, Asia, Europe and Latin America.

Company: rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. rfxcel is headquartered in the USA and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

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Steps to Compliance: How Best to Prepare for Russia’s 2020 Pharma Regulations

Preparing for Russia’s regulation requirements might seem like a mountain to climb, but it’s a necessary journey for companies that want to remain in or enter the 10th largest pharmaceutical market in the world.

With the global market expected to reach $39 billion by 2021, it’s no surprise that Russia wants to tighten its oversight of the pharma supply chain and work to eliminate counterfeit and low-quality medicines. Notably, unlike other countries, Russia will require complete serialization and traceability of over-the-counter (OTC) medicines.

With such complex serialization regulations looming — they go into effect on January 1, 2020 —companies that have not proactively started preparing need to act now if they want to meet the deadline for complete unit- and batch-level traceability. Let’s look at four ways you can help ensure your organization will be compliant by the New Year.

Establish a dedicated project team and manager
You must make sure that everyone understands the importance of serialization: Without it, you won’t be able to sell products in Russia after January 2020. For your bottom line, compliance means cost reductions through more efficient logistics management and a diminished impact on profits from counterfeit and falsified products. And of course, compliance means access to lucrative international markets.

Pharmaceutical companies seeking to commercialize in Russia should be establishing dedicated project teams and project managers to maintain the momentum of preparing for compliance. Project teams should have a comprehensive understanding of how drugs move through the supply chain, from beginning to end, including where ownership is passed from one party to another.

You should appoint team members who are responsible for ensuring your company has a clear vision of its IT landscape and how your data flows. This means understanding the operation system being used at each stage of the supply chain and how it connects actors.

Conduct a pilot phase
A pilot phase can make a huge difference to formal implementation. It can reveal potential setbacks, and is a chance to discuss and debate the exact functional requirements needed to be 100% compliant by January 2020.

The pilot phase is also an opportunity to confirm that you have all the equipment necessary for the new labeling information. For example, it’s vital to look at the needs for Data Matrix Codes and Electronic Data Interchange (EDI) labels, as well as assess if you’ll need an Electronic Document Management System (EDMS).

You should also look at what kind of cash register and related software you have and how they will work with the marked products. If you have any doubts about this, speak with your supplier to ensure their equipment is ready to be fully compliant. To launch a pilot phase properly, you should have the right labeling and scanning equipment, cash software, accounting systems, along with a sophisticated IT solution.

Make sure you have the right technology partner
Chances are you’ll have to partner with a technology company to meet regulation deadlines, so you should choose one that has your best interests in mind. Engage with a partner that is willing to work collaboratively to develop a system that can bend to accommodate the yet-to-be-announced final details of the regulation and also meet future requirements.

Your partner should be a recognized, experienced provider that demonstrates credibility and can prove that they’re able to stick to tight time frames and deadlines. A great partner will prioritize your success (as well as their own), keep you aware of changing global regulations, and collaborate with you to customize solutions that adapt to changes in the industry and the wider marketplace. They must have a proactive, “can-do” attitude; a “break-fix” approach will not work.

Clear, two-way communication is another top priority. Regular calls, updates, and meetings will maintain your relationship. Interactions should be free from confusing technical jargon. And if the direction of your business shifts, your partner needs to utilize technology to assist the transition.

Importantly, as you’ll be sharing significant amounts of your data, you need to make sure your tech partner has an iron-clad commitment to cybersecurity and data management. You should be asking any potential partner about its processes and procedures in these critical areas — and getting the right answers — before agreeing to work with them.

Last but not least: Act now!
Russian serialization will be here in about six months. Every pharma company that has not begun preparing needs to act now. Because serialization has far-reaching implications that transcend international borders, being ready requires a comprehensive management process. The best partners will support your organization as 2020 approaches if you show you’re committed to being prepared, communicate clearly, and budget ample time for onboarding.

Author: Victoria Kozlova 

Victoria Kozlova is a general director at track and trace software company rfxcel

Company: rfxcel

rfxcel is a track and trace software provider with leading-edge solutions to help organizations track their entire supply chain, meet regulatory compliance requirements, and protect products and brand reputations. For the last 15 years, manufacturers, wholesalers, distributors, and dispensers have trusted rfxcel to provide complete compliance and traceability solutions. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs. rfxcel is headquartered in the USA and has offices in the EU, Latin America, India, Russia, the Middle East, Japan, and the Asia-Pacific region.

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