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How rfxcel’s Track and Trace Solutions Secure the Government Supply Chain

rfxcel was formed in 2003 to help the pharmaceutical industry secure its supply chain. As we grew into and succeeded in new commercial business sectors, our leadership team made the strategic decision to enter the public sector and help our government secure its supply chain and protect the public health and safety.

Today, across all the industries we serve, our customers have come to rely on our flexible, customizable track and trace architecture to create solutions that best meet their business needs and adapt as they grow. Let’s see how our technologies help government be prepared for every mission-critical

Ensuring product integrity and public safety throughout the government supply chain

An attack on our food, pharmaceutical, or energy supply chains could be disastrous, and more government departments and agencies are realizing that protecting supply chains is a matter of national security. Like our commercial customers, government organizations can use our full stack of flexible, interoperable, and scalable solutions to see any product in real time, 24/7. Continue reading to find out how.

rfxcel’s Traceability System (rTS) is the core of our traceability solution. It comprises a suite of products that empowers government to link manufacturer serial numbers from production to each time a product changes ownership across the supply chain. All of our products are interoperable with existing government systems and sensors, so implementation is fast and secure.

One of those products is our rfxcel Integrated Monitoring (rIM), which tracks the physical movement and environmental conditions of items in real time as they move through the supply chain. Powered by Internet of Things (IoT) technology, it collects a tremendous amount of data that enables deep visibility into the supply chain from anywhere in the world. It can monitor mission-critical parameters such as temperature, deviation from prescribed routes, battery levels, shock, and tilt, allowing government to take action and prevent damage to products. It can also prevent diversion and theft, and help authorities locate bad actors that want to disrupt supply chain operations.

With rIM and our other solutions, rfxcel delivers unprecedented supply chain security by tracking products and verifying authenticity right down to the unit level. This results in readiness for first responders, law enforcement, and military forces, which can be prepared with the right equipment at the right time. Furthermore, regulators can expedite the identification and removal of counterfeit products, including medicines, from the supply chain.

Customizable for maximum security, accountability, and awareness

rfxcel’s solutions can be used individually or together as a seamless whole to support a comprehensive supply chain traceability and visibility strategy. For government, this means supply chain and related operations will remain secure, aligned, and fast.

No matter how it’s configured, rTS will strengthen the networks that distribute goods and services. It ensures supply chains have the tools to prioritize food, pharmaceuticals, and other vital supplies — during day-to-day operations and emergencies.

With rfxcel track and trace solutions, government can secure supply chains, prioritize critical capabilities, and maintain situational awareness. We provide the solutions and services that make supply chain networks safe and resilient and empower government to proactively manage operations and respond appropriately and quickly.

To learn more, contact our Washington, D.C.-based Government Solutions team today at gov@rfxcel.com or 925-824-0300. Also, take a minute (58 seconds, actually) to watch the video below, which is a succinct introduction to our government supply chain capabilities.

 

 

rfxcel MobileTraceability App for Pharma: Mobile Data Capture from Virtually Any Location Optimizes Supply Chain Logistics and Patient Safety

rfxcel is dedicated to optimizing the pharmaceutical supply chain. We want to remove boundaries, improve data capture and usage, and ensure patient safety.

With our new and improved rfxcel MobileTraceability application, pharma companies, dispensers, and pharmacies can do all of these things — and much more.

rfxcel MobileTraceability brings our industry-leading track and trace capabilities to virtually any location, including places that traditionally may not have had absolute visibility in your supply chain, such as distribution centers, warehouses, pharmacies, and hospitals. It also brings the power of a digital supply chain, moving you away from paper records and streamlining your operations.

The app integrates the power of our signature Traceability System (rTS) with the built-in scanning capabilities of mobile devices and scanners. With rTS tracking and reporting capabilities on a mobile device, the workflow of the pharma supply chain is simplified. For example, manufacturers and distributors can perform critical tasks quickly and easily, such as verifying shipments and receipts, and aggregating/disaggregating pallets and cases.

rfxcel MobileTraceability supports multiple platforms, from ruggedized devices with optimized scanners to consumer devices with built-in cameras, such as smartphones. Now you can select devices that meet your needs and budget without comprising on performance.

With these capabilities literally right in their hands, dispensers can:

  • Ensure only legally compliant items are dispensed
  • Scan and verify dispensed products
  • Decommission products
  • Scan sealed bags to automatically decommission all packs inside

The app also offers key benefits to pharmacies. Its simple user interface makes it easy to use, reducing the chance of errors and false override of alerts. It also facilitates intense collaboration and coordination externally and internally to:

  • Achieve regulatory compliance
  • Improve risk management, recall management, and inventory management
  • Automate and review distribution flows and processes
  • Create specialized receiving capabilities
  • Ensure patient safety with store returns and recalls functionality
  • Gain true end-to-end supply chain traceability

rfxcel MobileTraceability adapts to any workflow, transforming how you manage your supply chain. The pharma industry has unique demands, and a one-size-fits-all approach just won’t work. The app allows us to be as flexible as you need us to be and to deliver granular visibility and flexibility anywhere your supply chain goes. Contact us today to learn more about what rfxcel MobileTraceability can do for you.

How a Full-Stack Supply Chain Track-and-Trace Solution Benefits the Food & Beverage and Pharma Industries

The food & beverage (F&B) and pharma industries aren’t quite polar opposites, but they are very different. This includes their supply chains.

For example, F&B companies must get their products to grocery stores, hotels, airports, restaurants, and other “consumer-centric” clients, while pharma companies’ primary customers are hospitals, clinics, pharmacies, and other stakeholders in the health care system. Their products also have different environmental and compliance requirements.

But there are similarities. Both industries want to ensure the purity and safety of their products. Both want to get their products to end users quickly, securely, and on time. Both work with diverse trading partners, including wholesalers and distributors. Both want their supply chains to optimize operations and boost bottom lines.

And there’s one more similarity: Both can benefit from a full-stack supply chain solution — like our signature rfxcel Traceability System (rTS) platform.

What is a “full-stack” supply chain solution?

A full-stack supply chain solution gives customers a complete, integrated set of technologies to control their entire supply chain. rTS is a full-stack solution comprising software that empowers companies to see deeply into their supply chains in real time. It yields data that can optimize operations, and gives peace of mind because everything is managed and accessible in one secure, private cloud-based location.

Furthermore, full-stack solutions are easily customizable and system validation is automated based on customer requirements. Users determine the features they need and choose the appropriate components. For example, rTS includes solutions that are critical for both F&B and pharma, such as rfxcel Serialization Processing, rfxcel Compliance Management, and rfxcel Analytics. But it also includes products designed for each industry, such as rfxcel Raw Ingredients Traceability for F&B and rfxcel Verification Router Service (rVRS) for pharma.

What are the benefits of a full-stack solution?

Probably the greatest benefit of a full-stack supply chain solution is “all-in-one” power and convenience. Instead of a piecemeal approach to supply chain management — using different providers for different solutions — a full-stack solution centralizes your operations.

F&B and pharma companies have to ask themselves, “Do I really want to spend my time finding a different tool for every task? One for compliance, one for serialization, one for data analytics, one for scanning, and on and on and on?”

They also have to ask what problems this approach might cause. Can they be certain their solution providers can communicate with one another? Are the providers actually in competition with one another? Can they share data quickly and securely? If something goes wrong with one solution, will the problem cascade throughout the supply chain — and can they find the right person to fix it?

Another advantage is that a full-stack solution provider will understand your needs much better than a disparate collection of providers. They can analyze your entire supply chain, identify your needs, and tailor just the right combination of solutions to meet your goals. It’s a holistic approach that sees both the individual components of your supply chain and the end-to-end “big picture,” from manufacturing to the consumer.

Plus, you’ll have just one point of contact for all your inquiries and support. If you have a question or a problem, you’ll know that you’re contacting the right person and you’ll get answers quickly.

rfxcel’s full-stack traceability solutions in action

Let’s illustrate some benefits of our full-stack traceability solution by highlighting rTS, rIM, and our MobileTraceability app. With these, pharma and F&B companies have all bases covered in a seamless, integrated, end-to-end supply chain traceability solution.

With rTS, pharma companies will know they’re compliant with regulations everywhere they do business, such as the Drug Supply Chain Security Act (DSCSA) in the USA, the Falsified Medicines Directive (FMD) in the EU, as well as regulations in Russia, Saudi Arabia, China, Brazil, and other countries. F&B companies will know they’re meeting the requirements of the U.S. Food and Drug Administration’s Food Safety Modernization Act (FSMA), the UK’s Food Standards Agency, the Canadian Food Inspection Agency, and others. They’ll also be compliant with GS1 standards and their customers’ requirements.

Using rIM to monitor products in real time as they move through the supply chain, both industries can ensure they’re meeting environmental requirements, such as temperature and humidity parameters. If a problem arises, rIM sends an alert and they can take immediate action.

Key actors at every node of the supply chain can use our MobileTraceability app to scan and record events, track products, and manage items down to the unit level. For example, using the app on a smartphone with a scanner, pharma stakeholders can verify, decommission, and aggregate serialized products at any stage of the supply chain. A F&B stakeholder can record data about raw materials (e.g., batch number, supplier, date of arrival, expiration, and analytics) and trace any ingredient that’s part of the finished good.

A full-stack supply chain solution has numerous benefits for F&B and pharma — as well as any other industry that wants to simplify, coordinate, and optimize its supply chain. To learn more about how our full-stack rTS platform can transform your supply chain, contact us today!

Selecting the Right Serialization Solution for You

Serialization solutions are not all created the same, and several factors must be taken into account when deciding which solution fits your needs.

Data integrity needs to be at the forefront of your decision making process. While nearly all solutions offer compliance and data validation, few provide continued data validation and verification after implementation. Continued data verification is immensely important, as errors do happen. Product master data needs to be accurate and aligned for an efficient and safe supply chain.  Having a serialization solution provider that works with you closely and catches errors before they get into the system or network is crucial.

A serialization solution provider needs be flexible for any product change processes that could create data inconsistencies between trading partners. Having a solution provider that works with all of your trading partners is important to create a system that meets all data and product standards.

Beyond data integrity – control, flexibility, trading partner connectivity, and scalability should all be key factors when picking a solution.

Most serialization and traceability software are built on cloud computing using either a multi-tenant or single-tenant architecture. Solution providers selling a multi-tenant architecture often over simplify this approach, selling it to their customers as a way to get automatic software upgrades with little or no effort. But, beware – these uncoordinated updates force customers into system upgrades with little or no coordination or consideration for their own system configurations. This can be incredibly disruptive to the customer and require revalidation and new system configurations. Conversely, single-tenant solutions give the customer control of when they implement updates, allowing them to upgrade at a time that is not only convenient for them, but allows them to ensure their configurations remain intact.

An effective serialization solution will also be flexible enough to fit all of your individual needs, while being scalable enough to cover all of your manufacturing and distribution needs. The solution should take into account what your systems require now and what they will require in the future as your company grows. Alongside flexibility and scalability, your solution should be connected to hundreds of other trading partners, allowing instant communication between network members and transmission of serialization and / or T3 data (transaction statement, transaction history, transaction information).

rfxcel’s solutions are built with our customers in mind. Our single-tenant architecture ensures that our solutions are flexible and scalable, all while ensuring our customers have complete control over their systems. We provide expert data monitoring to confirm that all of your products are properly serialized and traceable. Our solution uses over 100 data checks to verify your data and flags errors, giving you the time to fix issues before products ship.

The global supply chain never rests, and our global support and solution experts are available 24/7 to take your questions. Contact us today to learn more about our serialization and track and trace solutions or to talk with of our solution experts.

Serialization Solution

DSCSA Compliance

The United States has been taking initiatives to discourage the introduction and distribution of counterfeit drugs. With that goal in mind during November 2013, the Drug Quality and Security Act (DQSA) was introduced. DQSA is a federal framework to address supply chain security. The Drug Supply Chain Security Act (DSCSA) outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S.

The DSCSA compliance laws aim to facilitate the exchange of information at the individual package level about where a drug has been in the supply chain to:

  • Enable verification of the legitimacy of the drug product identifier down to the package level
  • Enhance detection and notification of illegitimate products in the drug supply chain
  • Facilitate more efficient recalls of drug products

Serialization for the US is centered on the Standardized Numerical Identifier (SNI). The SNI is a national registration and serial number for the medicinal product and each pack. Each unit must also carry the lot number and expiry date as a mandatory requirement. All data is a 2D data matrix code and printed on the pack. The serialization data are reported to the parties involved so that the flow of goods in the supply chain can be re-traced.
rfxcel Traceability Platform is designed according to the internationally accepted ANSI/ISA S95 standard. Meaning, an efficient track-and-trace solution should integrate with the packaging equipment, line controllers, and Central Repository via standard interfaces for seamless communication. This architecture ensures seamless information exchange in both directions. It is flexible enough to catch errors before unacceptable product accrue. For example, production can be stopped in instances of missing or inconsistent data to avoid manufacturing unusable (i.e. incorrectly serialized) products.

The DQSA affects:

  • Manufactures
  • Wholesale distributors
  • Repackagers
  • Third-party logistics
  • Pharmacies

DSCSA compliance implementation phases
Lot-level management
Started on January 1, 2015, for manufacturers, wholesalers, and repackagers, and July 1, 2015, for pharmacy (hospitals and retail): Share the 3T’s: Transaction Information (TI), History (TH), and Statements (TS) at the Lot (or Batch) level of identification.

Item serialization
Mid-term (2017–2019): Manufacturer/repackagers serialize packages of drug products using a product identifier (GS1 Global Trade Item Number® (GTIN®) or NDC), serial number, lot number, and expiration date.

Serialized item-level traceability
By November (2023), make available information that would allow supply chain partners to trace the ownership back to the initial manufacturer or repackager.

DSCSA COMPLIANCE REPORTS
The DSCSA compliance transactions or changes in ownership includes the following elements:

1. Transaction information (TI)‐includes the name of the product, strength and dosage form, NDC, container size, number of containers, lot number,
transaction date, shipment date and the name and address of the businesses previous and subsequent owner.
2. Transaction history (TH)‐ an electronic statement that includes the transaction information for each prior transaction back to the manufacturer.
3. Transaction statement (TS)‐electronic confirmation by the entity transferring ownership of the product.

Each business is required to provide the TI, TH, and TS to the subsequent owner for each transaction. Each party, buyer or seller, must capture and maintain the TI, TH, and TS for each transaction for six years.

Transaction statement confirms that the product is authorized under the DSCSA compliance laws and received the product from an authorized party.

  • TI and TS from the previous seller are received
  • Shipping only legitimate product
  • Systems and processes to perform verification
  • Did not knowingly provide false transaction information
  • Did not alter the transaction history

How can rfxcel help?
With over 14 years in the traceability business, rfxcel understands the need to fulfill these regulatory requirements. Pharmaceutical and biopharmaceutical companies need a reliable track-and-trace solution to have a strong process workflow.

rfxcel provides the following solution requirements:

  • DSCSA compliance with international anti-counterfeiting requirements
  • Support of GS1 labeling information
  • Management and randomization of serialization numbers in operations
  • Management of modular aggregation for item, bundle, pallets
  • Integration with centralized track-and-trace repositories
  • Verified product that is EPCIS certified
  • Handling of packaging orders and batch information
  • Dialogs to create, discard, aggregate, and disaggregate units and hierarchies
  • User management, including rights management & audit trail
  • Recording and reconciliation of used and unused serialization numbers

The industry trusts rfxcel Traceability Platform for its scalability and reliability. rfxcel meets the needs of serialization, DQSA compliance requirements, business value and competitive advantage.

rfxcel Traceability Platform offers:

      • rfxcel Integration Server – an integration engine to merge external systems with rfxcel products. These external systems can include ERP Systems (e.g. SAP, Oracle, IBS), Packaging Systems and Edgeware (e.g. Optel), Country-specific Drug Data Repositories and more
      • rfxchange – the ecosystem that connects formatted and mapped data to DQSA hub and any other global repository
      • Data processing and validation ensures no bad data gets into the hubs
      • Scan: scanning capabilities, shipping, receiving
      • Seamlessly data exchange and formatting for DSCSA requirements
      • Collaboration and integration with all partners, customers, and other solution providers
      • Works with multiple file formats (XML, SAP iDoc, PML, EDI, or any custom data types and file formats)

Contact us for a 20-30 minute demo.

Blockchain Technology in Pharmaceutical Supply Chain

Interview with Ramana Pinnam, Director of Product Management, about blockchain technology in the pharmaceutical industry

Perhaps you have heard tale of the up and coming technology called blockchain. Maybe you are an expert on blockchain technology and how it fits into the world of pharmaceuticals. Or perhaps you are like most of the world and you are unsure about what to make of blockchain and frankly you are afraid to ask anyone to explain. If that describes you, never fear! We recently had a fantastic opportunity sit down with Ramana Pinnam, Sr. Director of Product Management here at rfxcel,  after he presented at the 2017 HDA Traceability Seminar. Hopefully this conversation sheds as much light on blockchain technology as it has for us.

 

Could you give us a brief overview of blockchain technology?

Absolutely. Blockchain technology almost says it all in its name. Imagine the “block” as a piece of data and the chain is where that data hooks into place with all the other “blocks” of data. This is a very basic understanding of this technology. The idea behind blockchain technology is to create a secure online based and shared ledger of sorts. Like a banker would keep a ledger of all the transactions by hand, blockchain takes a certain category of transaction and locks in the data so it cannot be lost or misplaced. Blockchain in regards to supply chain has been used primarily in crypto currency transaction such as Bitcoin, but now we are seeing larger companies like Walmart using blockchain to keep detailed records of some of its food products. It is increasingly important in our world today to be able to efficiently track products and transactions from creation to when it reaches the consumers’ hands. Blockchain technology creates a very efficient avenue for that, and we are seeing some pharmaceutical companies beginning to investigate how it can apply to our industry.

 

Speaking of pharmaceutical companies, how does blockchain technology relate to the pharmaceutical industry?

Well, as of now it does not directly correlate or relate. Some companies are partnering together to research and decide if blockchain technology will be utilized as the future for tracking all individual medications and products manufactured by pharmaceutical companies. It seems to be a promising technology to incorporate into tracking products and mitigating risk of loss or counterfeiting of pharmaceutical products.

 

What are some Pro’s and Con’s about adopting blockchain technology?

The largest con right now is that we just do not know for sure if blockchain technology will do what we need it to do. A lot more testing needs to be done in the pharmaceutical industry. One of the main pros is also a con. Blockchain locks in data so it cannot be changed or altered. This is quite a positive when trying to track products, but user error can make this problematic. That is why appropriate education and training will be needed for those who adopt blockchain within the supply chain.

 

If you could, what type of timeline would you guess at for the full incorporation of blockchain into our industry?

As I said earlier, a lot more testing and research must be done. I am not sure of a specific timeline, but there are companies and organizations turning over rocks as we speak to see how blockchain can fit into the pharmaceutical industry. These things take time, but if the research and testing comes back promising we could see the full integration of blockchain technology in just the next few years.

 

After speaking with Ramana Pinnam we all felt a lot more confident in our understanding of blockchain technology. We hope that we at rfxcel can help you feel more confident about all trends in technology and pharmaceuticals. As far as blockchain technology goes, we are always committed to utilizing the best resources available for our clients. As more information becomes available about the application and use of blockchain technology into our industry you will be the first to know about it.

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. Their solution enables companies to protect patients and meet their compliance needs, while getting insights and visibility into their supply chain. Their relentless commitment to customer success and continuous innovation ensures that companies meet their requirements and protect those who depend on them.

 

Blockchain technology in pharmaceutical supply chain