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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

Unpacking the Pharmaceutical Serialization Process

Approaching pharmaceutical serialization is no easy task, but technology makes it infinitely more attainable.

 

While pharma companies are already required to have batch-level serialization, the upcoming deadlines – February 2019 for the Falsified Medicines Directive (FMD) and November 2018 for the Drug Supply Chain Security Act (DSCSA) – require unit level serialization. These deadlines are not far away, and failure to comply can mean harsh consequences for non-compliant companies. But, with all that is at stake, some companies have still not begun the serialization process.

 

Pharmaceutical serialization can be made easier through specialized software. However, implementation requires a careful approach, one that assesses the parts of your business that will be affected, and an understanding of requirements in the markets in which you will operate now and in the future.

 

The process of serialization affects more than just the manufacturing line, before implementing any serialization solution, executive leadership must address the importance of serialization and appoint a project sponsor to work directly with the solution provider. The project sponsor’s role is to champion the serialization effort, and work with the solution provider to create and manage a schedule that clearly identifies key tasks and implementation milestones. In addition to managing a schedule, it’s imperative that risks and mitigation plans are identified and tracked throughout the process. Having a plan in place to manage risks during implementation helps to avoid common pitfalls and gives priority to the concerns of both the customer and solution provider.

 

Although the process of serialization may be daunting, rfxcel’s serialization and traceability solutions and approach make the process more manageable. Our 60-day implementation plan is designed to quickly on-board your organization and establish connections with your trading partners in a repeatable fashion. Our approach provides your organization with a comprehensive and scalable solution that will meet compliance regulations today and in the future.

Pharmaceutical Serialization

rfxcel Awarded a Group Purchasing Contract by Minnesota Multistate Contracting Alliance

San Ramon, CA August 29,2019– San Ramon, CA rfxcel announces it has been awarded a contract with the Minnesota Multistate Contracting Alliance for Pharmacy (MMCAP) for FDA Drug Supply Chain Security Act (DSCSA) Compliance Solutions.

rfxcel’s dynamic traceability platform enables companies to protect patients, comply with regulatory mandates, e.g., DSCSA, and gain visibility into their supply chain. rfxcel’s commitment to customer success and continuous innovation ensures that companies can meet today’s requirements and tomorrow’s challenges.

The Minnesota Multistate Contracting Alliance for Pharmacy (MMCAP) is a free, voluntary group purchasing organization for government facilities that provide healthcare services. MMCAP has been delivering pharmacy and healthcare value to members since 1985. MMCAP’s membership extends across nearly every state in the nation, delivering volume buying power. Members receive access to a full range of pharmaceuticals and other healthcare products and services, such as medical supplies, influenza vaccine, dental supplies, drug testing, wholesaler invoice auditing, and returned goods processing.

“We are honored to be selected by MMCAP to help their members become and stay compliant with the Drug Supply Chain Security Act (DSCSA). The end goal of the DSCSA is to ensure the safety of patients and consumers. This is an exciting time of change in the industry and we look forward to helping MMCAP members meet this goal,” said Glenn Abood, rfxcel’s Chief Executive Officer.

 

About rfxcel

Founded in 2003 by Glenn Abood and Jack Tarkoff, rfxcel is the first company 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, and to enable customers to better manage their business today and deliver value tomorrow.

To learn more about rfxcel please contact us at https://rfxcel.com/contact-rfxcel/.

Herb Wong

Head of Marketing

hwong@rfxcel.com

(925) 824-0300

 

Top 6 India Pharmaceutical Manufacturers Choose rfxcel

San Ramon, CA August 22, 2018 rfxcel, the leader in track and trace solutions for the pharmaceutical market, today announced tremendous growth in India. rfxcel more than doubled its annual sales performance in India and APAC. This speaks to the significant market opportunities and demand for traceability technologies delivered by rfxcel.

Our rapid growth in India is the result of our dominant position in the serialization platform space and our emergence as the leader in track and trace technologies. Through our focus on customer success and product innovation, we have become the trusted global traceability standard for more than 300 brands,” said Vikash Pushpraj, Senior Vice President of rfxcel. “Over the past year, we have invested heavily in building traceability technology critical for regulatory compliance and supply chain visibility.  As a result, we have emerged as the essential traceability platform, focused on full-service on-boarding, 24/7 support, and the platform for true data integrity.

Traceability is the primary focus for the life sciences in 2018. According to a rfxcel customer survey of 100+ brands, 89% believe collaboration, full-service onboarding, continued support, and interoperability are important for a successful and secure supply chain. rfxcel is the first-ever traceability platform to help companies of all sizes and industries easily connect and integrate with trading partners, resulting in predictable outcomes and lower supply chain costs.

rfxcel’s unwavering commitment to our success has enabled us to grow our serialization program and engage our trading partners more effectively,” said a CIO at one of India largest pharmaceutical companies based in Mumbai, India; “rfxcel is an innovative company delivering cutting-edge technology and data-driven intelligence that we can leverage in our programs.

Because of this growth, rfxcel has achieved many major milestones, including:

Exceptional Business Performance in India: rfxcel more than doubled annual sales growth and its customer base in 2018; while securing wins with 6 of the top 10 pharmaceutical companies in India.

Exceptional Growth in Europe: rfxcel announced its successful expansion in the UK and EMEA, with triple digit revenue growth since 2017.  This includes an increase in sales headcount by 300% and an expansion in our delivery and support teams by 350% in the same period.

New Board Members: Chris Sultemeier (President and CEO of Walmart Transportation LLC.) and Martin Van Trieste (Chief Quality Officer and SVP of Quality at Amgen), joined rfxcel’s Board of Directors. Veterans of supply chain, Chris and Martin have played instrumental roles guiding highly visible supply chain and traceability efforts.

About rfxcel:

rfxcel is a world-class supply chain track and trace company. rfxcel provides leading-edge track and trace solutions to help companies meet regulatory compliance requirements, protect their products, and brand reputation. rfxcel has been an industry leader since 2003, expanding to locations beyond the US to include the EU, LATAM, India and APAC. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs.

 

Herb Wong

Head of Marketing

hwong@rfxcel.com

(925) 824-0300

 

It’s Not Too Late for EMVO Onboarding with rfxcel

The European Union’s Falsified Medicines Directive (EU FMD) is just a few months away. On February 9, 2019 the law takes effect and those companies who aren’t serialized and traceable will not be able to sell their goods. The pressure of this deadline necessitates action – immediate action – but, according to a letter from the European Medicines Verification Organisation (EMVO) to all Marketing Authorisation Holders (MAHs), about 1500 MAHs have yet to begin the EMVO onboarding – a critical step in ensuring compliance with the FMD.

Pharmaceutical Journal, in their coverage, stated “only 841 companies have completed the first stage of connection: the signing of a participation agreement. Of those, only 106 companies have progressed to become fully connected to the production environment of the EU Hub.” So far, only 5 percent of all MAHs are fully compliant with the FMD.

The EMVO, in its letter and in previous letters, has stated that the onboarding process can take up to six months, and the last time to ensure no delays or complications would have been to start onboarding by June of 2018. June of 2018 has past, and unlike the US DSCSA, there has been no announced delays in the enforcement of the FMD.

What to do now:

Companies that haven’t begun the onboarding process should begin as soon as possible. The EMVO stated that it will not be responsible for any MAH that fails to complete onboarding or fails to begin the onboarding process on time. This places enormous pressure on companies to begin the onboarding process; as of now there is no guarantee that the onboarding process will be done by February 9, 2019.

Fortunately, onboarding with the EMVO is easier when MAHs choose the right solutions provider. rfxcel is pre-certified with the EMVO, allowing new onboarding partners to skip steps in the technical onboarding process. To ensure compliance by the FMD deadline you should begin the EMVO onboarding process immediately.

Connecting to the EMVO is critical for compliance with the FMD, but more integral is actually being able to serialize all products at a unit level with a 2D barcode including a batch number, expiry date, global trade item number (GTIN) and a randomized serial number. If your manufacturing line is not already prepared for serialization, then you have bigger problems than not having started the onboarding process for the EMVO. Companies that are not compliant by February 9, 2019 will likely be placed in a very inconvenient position – they must either send their finished goods to a CMO already compliant with FMD to serialize their products, or they must manufacture an excess and release their products before February. Our advice is to get started immediately. Perhaps you’ll have to use a combination of some or all of these approaches, but you’ll be closer to the finish line and compliance if you get started today.

The rfxcel Difference:

rfxcel is already pre-approved by the EMVO, allowing our customers to skip steps in the EMVO onboarding process. Beyond being able to provide an expedited onboarding process, we promise to provide our customers with a short implementation process, extensive data verification, a system that the customer is in control of, and straightforward pricing.

It is not too late to begin onboarding with the EMVO. Contact rfxcel today to learn how we can help you comply with the FMD.

EMVO Onboarding

rfxcel Enhances Pharmaceutical Track and Trace Solution for Russia

San Ramon, CA August 16, 2018 – rfxcel, the global leader in track and trace solutions, releases enhancements to its compliance solution for Russia and kicks off additional customer implementations in the Russian marketplace.

Russia compliance is now fully embedded in rfxcel’s Compliance Management (rCM) and Serialization Processing (rSP) modules. The extended Russia support builds upon rfxcel’s awarding winning Traceability System (rTS) and continues rfxcel’s long-standing commitment to help customers meet global compliance needs.

rfxcel is actively rolling out its Russia compliance solution for pharmaceutical customers to meet the serialization, aggregation, traceability, and reporting requirements for the Russian market.  As one of the first compliance providers to implement for Russia, rfxcel is strategically positioned to help pharmaceutical companies achieve compliance well in advance of the January 1, 2020 deadline mandated by the Russian government.

Russia’s Federal law 425-FZ requires medicines to be uniquely identified across packing levels with additional Russia-specific cryptography.  Under Russia’s Federal law, participants must track and report products in various stages of the supply chain.  This information is reported to Russia’s centralized Federal State Information System for Monitoring Drug Circulation (FSIS MDC).

“We are extremely proud to work with our customers to meet Russia’s compliance regulations – arguably the most complex in the world.  Delivering a serialization, aggregation and reporting solution for compliance requires not only robust software, but also demands an experienced local and international team with the skills and flexibility to manage an end-to-end project.  rfxcel offers both the solution and service to ensure success,” said Mark Davison, Senior Operations Director, Europe.

Many pharmaceutical companies are challenged in providing resources to meet and deliver a fully validated compliance solution.  The rfxcel implementation team consists of both global and local Russian resources who provide a full-service experience.  This approach is extremely well received by our customers and allows them to shift the worry of compliance to rfxcel so they can focus on their core business.

 

About rfxcel

rfxcel is a leading-edge track and trace solution to help companies meet regulatory compliance requirements, protect their products, and brand reputation. rfxcel has been an industry leader since 2003, expanding to locations beyond the US to include the EU, Russia, India, Brazil, and APAC. rfxcel’s unique integrated track and trace software suite delivers better business outcomes and lowers supply chain costs.

To learn more about rfxcel or participate in rfxcel’s Russia compliance program please contact us at https://rfxcel.com/contact-rfxcel/.

 

Herb Wong

Head of Marketing

hwong@rfxcel.com

(925) 824-0300

rfxcel SNAP – A DSCSA Solution for Pharmacies

The Safeguard prescription drugs & protect consumers under the Drug Supply Chain Security Act (DSCSA) with rfxcel SNAP.

Enacted by Congress in 2013 and administered by the Food and Drug Administration (FDA), the DSCSA outlines steps to safeguard the public from counterfeit or adulterated drugs. Under the DSCSA dispensers / pharmacists are required to electronically track and trace certain prescription drugs as they enter their pharmacy. This is achieved through tracking and tracing T3 data (transaction history, transaction information, and transaction statement) generated at each step of supply chain from trading partners. The goal of the DSCSA is to have a fully electronic and interoperable system in place to track and trace prescription drugs by 2023.

Responsibilities of Dispensers Under the Drug Supply Chain Security Act (DSCSA)

Important Dates to Meet DSCSA Deadlines:

  • November 2017 – All lot level transactions should be electronic
  • November 2020 –Pharmacies/dispensers can only receive and engage with products that are encoded with a serial number and 2D barcode
  • November 2023 – All pharmacies/dispensers are required to have systems to support unit level traceability, enabling traceability back to point of origin

Under the DSCSA Dispensers Are Required To:

  • Electronically receive T3 data from authorized trading partners
  • Electronically store T3 data from all authorized trading partners for 6 years
  • Have a system in place to investigate and quarantine suspicious products, and then notify trading partners and the FDA of illegitimate or suspicious products
  • Generate T3 data for outgoing sales
  • Receive only products with serialized data encoded in a 2D barcode, by the year 2020

Meet DSCSA requirements with rfxcel SNAP

  1. Electronically connect with trading partners
    • SNAP electronically connects with your licensed and verified trading partners (primary wholesalers, secondary wholesalers, and manufacturers)
  2. Receive, store, and provide product tracing documentation
    • Accept and verify T3 product information (transaction history, transaction information, and transaction statement)
    • Store T3 data in an electronic format for 6 years or longer; in the event of an audit
    • Generate T3 data for outgoing sales and transactions
  3. Investigate and properly handle suspect and illegitimate drugs
    • Workflows that support the identification and quarantining of suspicious products
    • Electronic notification to the FDA and trading partners of illegitimate or suspect products

Contact rfxcel to learn more about SNAP our DSCSA solution for pharmacies and your obligations as a dispenser under the DSCSA.

DSCSA solution for Pharmacies Post

Serialization in Russia: Steps to Compliance

Note: Since this blog first appeared, we’ve written “Russia 2020: A Guide to Pharmaceutical Supply Chain Compliance,”  an easy-to-understand white paper that explains the fundamentals of the Russian legislation and puts it all in context. If you’re interested in what’s in store for consumer goods in Russia, check out our white paper about that industry.

 

On December 28, 2017, President Vladimir Putin signed Federal Law No. 425-FZ, establishing a path to serialization in the Russian supply chain. When the law was published the following day, it delayed the country’s serialization deadline from January 1, 2019, to January 1, 2020. Pharma companies now had an extra year to implement the legal requirements on serialization of drugs.

However, the serialization in Russia regulation is arguably the most complex centralized track and trace compliance regulation yet seen, and given that much of the detail is yet to be finalized, the industry is unsurprisingly being challenged by the timeframe.

So what are the details of the Federal Law, and how can pharmaceutical companies work towards compliance?

Federal Law No. 425-FZ

Under Law 425-FZ, in order to ensure effective quality control for pharmaceuticals and provide protection against fake and counterfeit medicines in Russia, a federal state IT system (the FGIS MDLP) is in the process of being set up in Russia to monitor the movement of pharmaceuticals from manufacturer to end user.

From January 1, 2020, pharmaceuticals manufacturers will have to put special identifiers on pharmaceuticals packaging that will enable the tracing of movements of pharmaceuticals from the manufacturer right up to the end user.

The specifications for these identifiers and the process for putting them on packaging is due to be published separately, while the details of the central system reporting system, which documents the key traceability events, their data structures and technical guidelines, are also still being finalized.  What is known is that it will be mandatory to report the date of every phase of each product – from manufacture through to dispensation. In addition, Russia will be one of the small number of countries globally where the aggregation of pharmaceutical products for tracking purposes is required.

Further complexity comes from the differing reporting and labelling requirements depending on the status of the pharmaceutical company in Russia. If the company is a member of GS1 Russia, a barcode, the serial number and the product code are compulsory. In the instance of aggregation, a GTIN, FEACN (customs) code and case serial number are also necessary. If an organization is a non-GS1 Russia wholesale organization, then the requirements are also to include a SSCC code on the package and a unique serial number for each case.

Other important changes have been introduced by Law 425-FZ. In order for pharmaceuticals and active pharmaceutical ingredients to be registered, details will now have to be submitted of the applicant and manufacturer’s registration as a taxpayer in their country of incorporation – they will need to show their tax ID numbers. The holders or owners of registration certificates for pharmaceuticals and the manufacturers of pharmaceuticals and active ingredients registered before January 1, 2018 will have to submit details of their registration as taxpayers by January 1, 2019 to the Federal Service for Surveillance in Healthcare, Roszdravnadzor.

Steps to Compliance

With MDLP currently in pilot and federal review of the initiative due imminently, any organizations who have yet to start their compliance project have little time left.

While the details remain to be finalized, the federal government has already communicated that any further extension to the deadline is unlikely. Indeed, there is even the likelihood that serialization for certain “vital and essential” medicines may be enforced during 2019.

So what steps should you be taking now, to mitigate the risk of non-compliance, and in the worst scenario – not being able to trade?

1. Establish a dedicated project team and project manager

Without executive buy-in and indeed buy-in across all organizational boundaries, there will no focus on the project and chances of success vastly reduced.

It’s vital that everyone across the business understands that without serialization, you will not be able to sell products in Russia after January 2020.

2. Engage in a pilot phase

Building in a pilot phase can make a huge difference to the formal implementation. This is a chance for discussion and debate around functional requirements. It also allows to you properly explore your Master Data Management processes.

Serialization is all about data, so you should have a clear vision of the IT landscape and how the data will flow – from the point of manufacture all the way through to the point of dispensation, and the generation of the compliance report to the federal system.

3. Think agile

Engage with a technology partner who will work in partnership with you to develop a system that can both bend to fit the yet-to-be-announced final details of the regulation, but also meet future requirements.

The best partner should be a recognised provider with experience, credibility and evidence that shows it can implement effectively within tight timeframes. A good partner will be committed to your success, keeping you abreast of fluctuating global regulations, and collaborating with you to customise solutions that adapt to changes in your business and the wider marketplace.

4. Act now

Serialization is an initiative that has far-reaching implications across global boundaries and as such requires a full change management process. Again, the best partners will be able to support you through this, but only if you allow enough time to fully on-board them.

Final Thoughts

With global deadlines – DSCSA; FMD; and now Law 425-FZ – looming, it is perhaps unsurprising that pharmaceutical manufacturers and wholesalers feel under pressure from the mountainous task they face.

However, while certainly a challenge, your upcoming serialization in Russia does not have to be problematic.

For more information on how rfxcel can help with your serialization in Russia requirements, and to watch our “Serialization in Russia” webinar with Dmitry Freydin, Reckitt Benckiser, please contact us below to get full access to the webinar.

To learn more about Russian Pharma Compliance click here.

 

 

DSCSA & the Verification Router Service Timelines and Updates

THIS WEBINAR ENDED. YOU CAN ACCESS THE RECORDING BELOW.

———

Wednesday, August 29, 2018
PDT: 9 a.m. | EDT: 12 p.m.

Please join rfxcel for a webinar that will provide insight into the upcoming DSCSA Regulation(s) for Wholesale Distributors/Dispensers and for details/updates on the Verification Router Service (VRS). During this 1 hour long presentation, we will discuss:


1. FDA/DSCSA Activities for Wholesale Distributors/Dispensers
2. Insight into the Verification Router Service (VRS)
3. Timeline/Updates on the HDA’s VRS Program
4. rfxcel’s VRS Pilot Options and Demonstration 

 

If you are unable to attend at the scheduled time, we encourage you to register anyway. We will be sharing this recording with all registered attendees.

 

Please note, after registering, you will receive a confirmation email containing information about joining the webinar.

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. The platform enables companies to protect patients, comply with regulatory mandates, and gain visibility into their supply chain. rfxcel’s relentless commitment to customer success and continuous innovation ensures that companies can meet today’s requirements and tomorrow’s challenges.

PLEASE FILL OUT FORM TO ACCESS WEBINAR RECORDING:

FMD: Six months, Six thoughts

Today is exactly six months before the Falsified Medicines Directive (FMD) comes into force. On 9th February, 2019, more than thirty countries in the European Economic Area will have new rules for coding and verifying prescription medicines. We’ve had two-and-a-half years of the three year implementation window now: what conclusions can we draw and what recommendations can be made? Here are six short reflections.

  1. It will happen.

Those of you waiting for Brussels or Brexit to cancel FMD are wasting your time. Even if there is a delay, FMD is not going away and the UK is tied to it until at least Dec 2020. Will everything be ready by February? No, quite clearly not, especially at pharmacy level. That doesn’t mean the whole project will stop.

  1. It’s too late.

If you’re a marketing authorisation holder (MAH) and still need to convert production lines then it is too late to be ready. You have two options. You can make excess inventory, release it before February, and hope it lasts until your lines are ready, or you can send your finished goods to a contract manufacturer (CMO) for coding. Both inconvenient, but you’re still in business.

  1. It isn’t too late.

There is still time to get ready if you just need software to manage and report serial numbers (eg to the European Medicines Verification Organisation, EMVO) or if you’re a downstream distributor or pharmacy needing to verify and decommission packs. If you haven’t started, but can make quick decisions and take standard options, then rfxcel can turn your enquiry into a contract within a week and have you implemented two months after that.

  1. Choose experience over price.

Saving a few thousand euros using unproven but cheap serialisation vendor is a false economy if you can’t sell or dispense products next February because they failed. It is too late for home-made solutions or inexperienced me-too suppliers. Competition means that prices are already pretty keen amongst the market leaders. Don’t chase the last cent.

  1. KISS

Simple FMD projects work best. Only make system linkages you need. Usually (for manufacturers) that means MAH to CMO and MAH to EMVO. For distributors and dispensers it means to your national system (NMVO). We can integrate our FMD solution with your planning software, warehouse system, dispensing software or your Apple Watch if you want to. We just don’t put those items on the critical path for FMD compliance. Starting with a standalone approach as part of a roadmap to deeper integration is the best balance of risk and ROI.

  1. Adapt processes, train people.

For every euro spent on vendor technology, several euros need to be spent on your own people and processes to bend them into shape. Don’t skimp on this bit. Pack-level traceability changes everything all along the supply chain. If people carry on with old ways of working your FMD project will fail: expensively.

 

At rfxcel we can move quickly but time is very short. If you haven’t started your EMVO on-boarding, it’s not too late. If you don’t like your current solutions provider, it’s not too late to switch. rfxcel can help!

FMD Six months