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PMA Fresh Summit Convention + Expo Roundup

rfxcel’s Food and Beverage team attended the PMA Fresh Summit last month in Anaheim, California. From October 17-19, we talked about the latest in food production, distribution, and marketing, and how companies that harness supply chain data will win the future. Here’s a rundown of the key takeaways!

1. New product innovation aimed at specific segments

Focusing on consumer interests and personalizing experiences continue to gain traction with food and beverage companies. For example, the ketogenic — or “keto” — diet has piqued the industry’s interest. It limits foods that are high in carbohydrates, such as sugar, bread, and pasta, in favor of foods with higher fat and protein content, such as meat, fish, cheese, eggs, and nuts. Leafy greens (e.g., spinach, kale, chard, collards) are also okay on keto.

2. Cauliflower and nuts make a (gluten-free) splash

The industry is taking notice of gluten — or, more precisely, a lack thereof. Producers are taking a commodity, cauliflower chief among them, and making it a value-add raw material to cater to brands making gluten-free products. Consumers want alternatives to traditional wheat- and flour-based products such as bread, pasta, rice, and snacks. Foods with rye and barley are also no-no’s in a gluten-free diet. We’re talking whole grains (e.g., quinoa, brown rice, oats), fresh fruits and veggies, red meat, poultry, seafood, plant-based proteins (e.g., legumes, nuts, seeds), and traditional soy foods such as tofu and edamame. Cauliflower rice has been grabbing headlines lately, and nut crusts have also become very popular.

3. Functional ingredients are trending

A functional ingredient is a bioactive compound typically recovered through separation, purification, or concentration techniques. Medium-chain triglyceride (MCT) oil is a popular example. It’s made from coconut or palm kernel oil, is easy to digest, and the body readily turns it into usable energy. Today, it’s added to smoothies, bulletproof coffee, and salad dressings. Look for functional ingredients to continue to gain steam as consumers see them as nutritional must-haves.

4. Using supply chain data to make business better

rfxcel is all about the data, so we were very excited to exhibit our latest track and trace innovations, which work together to yield real-time validated data at the unit, case, pallet, and lot levels.

We ran a live demo of our Integrated Monitoring (rIM) solution, which works with any sensor and gives users an array of super-rich data, from cut-to-cool time to in-transit conditions on land, sea, and air. We brought our improved MobileTraceability app along to show how it captures and reports on data when and where it happens and builds trust by empowering consumers to validate a product’s provenance. And, of course, we showcased our signature Traceability System (rTS), which has been empowering supply chain excellence since 2003.

Visitors to our booth saw how our solutions harness mobile technology and the Internet of Things (IoT) for the most complete view of production and distribution. Growers can collect and report accurate data from the field. All trading partners have access to high-quality, real-time data — including data from sensors — that they can use to improve operations and customer experiences. It’s too much to get into here, but check out our short video to see some of what we can do!

Conclusion

As consumers demand more diet-specific products and diverse raw materials and functional ingredients continue to enter the supply chain, you need to proactively manage risk and traceability/visibility. If you’re looking for supply chain solutions that yield the data you need and can adapt to industry trends, look no further than rfxcel. It doesn’t matter which consumers you need to reach or how you need to configure and track your supply chain. From keto devotees and gluten-free consumers to people who just want to know where their produce was grown, we’ve got you covered. Contact us today to book an appointment.

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!

No Leniency for Wholesale: Start Preparing Now to Meet the DSCSA VRS Deadline

The DSCSA VRS deadline is one of the most important milestones the pharmaceutical industry needs to meet. The Drug Quality and Security Act (DQSA) was enacted by Congress on November 27, 2013, in doing so amending the Federal Food, Drug, and Cosmetic Act to grant the Food and Drug Administration more authority to regulate and monitor the manufacturing of compounded drugs.

Title II of the bill, the Drug Supply Chain Security Act (DSCSA) is designed to establish requirements to facilitate the tracing of prescription drug products through the pharmaceutical supply distribution chain. It outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed. This will enhance the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect consumers.

Adopting a phased approach, there are two key deadlines for different stakeholders: November 26th 2018 is the widely acknowledged deadline for pharmaceutical manufacturers and repackagers; however, given that the FDA has already pushed this deadline back once by a year (from November 2017), the second deadline is unlikely to be met with similar lenience.

On November 27th 2019, the DSCSA VRS deadline is enacted.  The wholesale industries must be compliant and only accept products that contain a serial number or product identifier, and they must verify this product identifier before they can go on to resell these goods. They must also be able to complete a validatable returns process.

To complete this process in specific regard to returned products that are saleable, the Verification Router Service (VRS) initiative was highlighted by the Healthcare Distribution Alliance (HDA) in its efforts to lead the industry in implementing the act. Essentially the VRS community consists of a third-party routing service, comprising requestors, responders, VRS providers, and a governance body to help manufacturers and distributors work together.

Under the proposals, the responders – ie. the manufacturers –  are responsible for providing repository connectivity information to the VRS and providing appropriate responses to the requesters’ (ie. the wholesale distributors) verification requests by matching the product identifier received from the requester with the product identifier in their repositories.

This level of collaborations requires tools for manufacturers and distributors need to work together. And these tools require testing – in minutiae.

Today, various solution providers, including rfxcel are in the process of providing a VRS. By the end of Q2 2018, industry testing is expected to start. The industry testing will consist of two rounds of testing, where there will be updates and modifications to the VRS specification to accommodate learning’s from the first test. Final revisions and refinements of the VRS will go in place with the final report published by the end of Q4 2018. Therefore, the VRS is expected to be available in early 2019, in readiness for the November deadline.

Lessons learned

However, as mentioned, it’s unlikely that the FDA will be lenient with this second deadline. It is therefore important to be aware that the duration of the testing depends on a lot of different things. It is going to be dependent on the readiness of your trading partners to start testing, and be determined by the quality of the data you received. You will need to expect some problems and be able to account for that within your schedule.

Analysing the recent HDA meeting back in February, we have put together our top tips to ensure you meet the upcoming DSCSA deadline:

  • Start talking with your providers, NOW! If you haven’t started implementing solutions yet or looking into your options, this is the perfect time to start.
  • If you are selecting vendors, make sure you understand the level of service provided by these providers. Everyone has a different way of managing the implementation process, so it’s not all the same.
  • Understand the total cost of ownership or the total cost of implementation. Make sure you have resources in the budget for that so you’re not surprised when the project starts.
  • We recommend that engage your trading partners to mutually understand the impact of your plans. This is probably the most important phase that you’ll need to go through. Your trade partners have different schedules, they may have different commitments to other customers that they are exchanging information with. So as part of this, make sure you understand the proximity exchange and make sure you reach out to your key suppliers in time.
  • Finally, the HDA does require continued testing implementation regarding serialized items. Make sure that you schedule ample time to test the implementation. Run through the proper test cases with your trade partners as part of the on-boarding process.

To learn more about the DSCSA VRS deadline and rfxcel’s VRS pilot project please contact us.

 

Legal Note *We are very familiar with the DSCSA requirements and the DSCSA implementation we are not familiar specific trading partners or contracts or business requirements. As a result we do recommend that you have them all reviewed by your legal team to make sure that DSCSA law and DSCSA VRS deadline might apply for your specific situation.

DSCSA VRS deadline

European Union Falsified Medicines Directive is Nearing

The European Union Falsified Medicines Directive (FMD) is close to taking full effect. On February 9th, 2019, all regulations regarding serialization and traceability become enforced. Failure to comply with these regulations will inevitably cause product launch delays. No serial number means no sale.

Serialization will be a necessity for sale of virtually all prescription only medications in Europe. But it is not enough to just print a serial number onto every batch.

Each individual unit must contain a 2D data matrix barcode that contains a unique Global Trade Item Number (GTIN) that refers to a specific stock-keeping unit, a unique serial number, the batch number, and the product’s expiry date. Some countries require even more information.

Further, each individual product needs to be able to be traced from manufacturer all the way to the pharmacist’s point of sale. For the pharmacist to be able to reference this information, each unique barcode will be logged with the European Medicines Verification Organization (EMVO) hub.

The process for becoming compliant is not short, and putting off starting the serialization journey is dangerous, especially as the EMVO on-boarding queue starts to bottleneck as more and more companies enter that stage in their serialization process. Acting fast can save months of time and ensure compliance by the February 2019 deadline.

But choosing the right partner with the right serialization solutions can help this otherwise onerous process, as well as help with compliance in other regions, as deadlines for serialization in other countries are also fast approaching.

With our 60 day implementation plan, rfxcel provides a quick on-boarding plan for all of your serialization needs. rfxcel’s solutions are secure as well as comprehensive, providing compliance for a multitude of regions, including the EU.

For more information on the European Union Falsified Medicines Directive and compliance needs, rfxcel provides a number of resources, including a comprehensive whitepaper found here

European Union Falsified Medicines Directive