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rfxcel – EMVO Technically Certified Connection Provider

San Ramon, December 21, 2017 – rfxcel, a global Track & Trace company, has been confirmed as a EMVO Technically Certified Connection Provider. This provides the ability for pharmaceutical manufacturers to use rfxcel to connect their product master data to the European Hub, and to meet EU Falsified Medicine Directive (FMD) serialization and compliance requirements.

The European Medicines Verification System (EMVS) is a pan-European system operated by EMVO, to enable medicines to be verified at the point of dispensing. Under the terms of the EU Falsified Medicines Directive (FMD) from 9th February 2019, Marketing Authorization Holders within the FMD’s jurisdiction will be required to upload their product serialization data via the EMVS European Hub.

As a EMVO Technically Certified Connection Provider, rfxcel will enable Marketing Authorization Holders to capture and report their serialized data and related transactions to the European Hub via a validated, secure and cost-effective solution.

“This marks another major milestone for rfxcel as we continue to grow to meet the traceability and regulatory needs of the pharmaceutical industry in Europe.  We are excited to offer the most flexible and feature-rich solution to aid EMVO in its mission to protect the drug supply chain”, said Glenn Abood, CEO of rfxcel.

As the pioneer and leader in traceability solutions for the Life Sciences industry, rfxcel provides its customers with a robust and sophisticated platform with a low total-cost-of-ownership. The EMVO certification – combined with a recent $30M growth capital infusion, the acquisition of Frequentz assets, and important key hires in Europe – widens the Company’s lead as the most versatile player in the industry.

 

About rfxcel:

rfxcel is the leading provider of SaaS-based track and trace solutions. Their 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.

 

Contact information:

Herb Wong, VP of Marketing

hwong@rfxcel.com

www.rfxcel.com

Leaders in Track and Trace Join rfxcel Executive Team

As part of rfxcel’s continued commitment to serve its global customers, rfxcel is pleased to announce that key leaders in track and trace join rfxcel Executive Team to drive global growth.

Jim Moore joins rfxcel as Senior VP of Corporate Development and GM of International Operations.

Jim has been an advisor to rfxcel, led the Company’s recent $30M capital raise with Kayne Partners, facilitated rfxcel’s entry into new geographies such as India and Europe, and completed the asset purchase from Frequentz. Jim has a unique track record of success in enterprise technology operations, analysis and investment banking.

“I am excited to bring my experience to drive international growth, partnerships, and M&A to further rfxcel’s mission to combat counterfeit pharmaceuticals, food and other products critical to the consumer”, said Moore.

“Jim has been invaluable in helping us formulate our capitalization and growth strategies and we are very pleased to have his experience and creativity added to our senior management team”, said Glenn Abood, CEO.

Simon Manley joins rfxcel as its new Commercial Director for Europe.

Simon will be responsible for driving rfxcel’s overall sales strategy and offerings to both existing and new clients in Europe. Simon will oversee marketing, strategic business partnerships and sales for Europe.

Simon joins from Oracle, where he was Sales Director for EMEA in the Health Sciences Global Business Unit, resulting in a huge expansion in sales growth across Europe, Middle East and Africa. Prior to this he was Vice President of Sales and Marketing at McKesson, a pharmaceutical distributor and the 5th highest revenue generating company in the US.

Commenting on the new appointment, Jim Moore said: “Simon brings relevant know-how to rfxcel and will be an asset to the management team. His knowledge of sales, customer satisfaction and international experience will be invaluable as we look to grow our presence in Europe.”

Manley commented: “I look forward to expanding rfxcel’s business both in Europe and globally. rfxcel’s commitment to customer success and continuous innovation ensures that customers meet their requirements and protect those who depend on them.  I am proud to be working with a team that can deliver all of this”

As the pioneer and leader in track and trace solutions for the Life Sciences market, rfxcel provides solutions to ensure customer success and secure their supply chain.

 

For more information contact us:

Herb Wong, VP Marketing

hwong@rfxcel.com

rfxcel.com

 

About rfxcel:

As the pioneer and leader in track and trace solutions for the Life Sciences, rfxcel provides solutions to improve the safety, quality, and security throughout the Life Sciences supply chain.

Private Cloud for Compliance Requirements

Understand how to meet compliance requirements with a private cloud module.

 

So you’re thinking of buying a cloud-based serialization L4/L5 solution. You’ve read some marketing materials and maybe the idea of a shared network appeals, because you know another company who’s using that system. Before you write the purchase order, read on.

Who will validate your cloud-based serialization system?

Under the rules such as 21 CFR Part 11 and EU GMP Annex 11, YOU are responsible.  You can use vendor tools, templates and widgets but no-one else can sign-off on the quality for you. Therefore, whenever the vendor system changes you need to react.  You remain responsible for your own data quality so every change is a risk. Think about what risk assessment and validation burden you are prepared to accept, before you choose your vendor.

How often do you need to re-validate?

That depends on your tolerance for risk. Shared cloud, multi-tenant systems inherently change much more frequently than private cloud, single-tenant solutions. They have to adjust to continuous demands from all the companies using the shared system. If a change made by your shared cloud service provider could impact your business processes and data quality, you must conduct a risk assessment process.  Colleagues tell us that running that process every week or two gets tedious. If there are major changes then you may need to fully re-validate some or all of your data connections more often than you’d like. Furthermore, on a shared cloud, this will not happen at a time of your choosing but will be driven by the vendor’s considerations.

 

Is there an easier way?

Private cloud solutions, like those provided by rfxcel, don’t have the same issues.  We give you your own software instance, within our secure cloud environment.  In our model, your validated system remains locked down until you decide you want to update it.  You can roll multiple patches and updates into one change event, and schedule any IT resources you need well in advance. Private cloud architecture doesn’t mean you’re not linked to the outside world. We provide a cloud-based exchange server which is used by hundreds of entities. We routinely exchange data with all of the major system providers on a daily basis, so you’re not locked out of your CMOs or logistics partners, even if they made a different choice.

 

Data integrity means checking not assuming

Don’t forget that mistakes happen, even in validated systems. It may surprise you that some of our competitors don’t check data. They assume that what comes in is correct, and pass it on. We make over fifty checks on data fields to ensure that even if something goes wrong you’ll spot it before an error becomes an incident. The cost of a recall is usually more than a million dollars, so make sure you give yourself every chance of avoiding one caused by a serialisation error.

  

Contact us today to see how rfxcel can help you to be compliant without unseen validation burdens and data quality risks.

 

Falsified Medicine Directive 5 of 5 – Maximize Return on Investment with Serialization Software

What happens after a company serializes their products? Is there a value beyond compliance?

Digital health is about making the product, the person and the medical experience a seamless experience. In the long term, value beyond compliance is building the future of healthcare and supply chain with data and analytics. In the short term, from the supply chain perspective, having things individually traceable means you can associate data with that product, you can associate them with temperature, humidity and location. Compliance becomes multi dimensional as it moves through the supply chain. This is a technology fusion in the next coming years. Value beyond compliance in the supply chain means controlling your brand and products in real time, letting data increase efficiency and adding revenue.

 

Is it true that all serialization solutions provide the same ROI?

A simple and basic system will only serve for a few years but if it cannot adapt with the changes then it is a bad investment. The more intelligent pharmaceutical companies are thinking ahead. They ask about the extensibility of the product, where is the long term validation, how to manage this through the lifecycle.  This type of serialization software takes things way past compliance placed by the Falsified Medicines Directive (FMD) in Europe and the Drug Supply Chain Security Act (DSCSA) in the United States. There is a return on investment that can be obtained from a platform for serialization over the long haul.

If companies look at a serialization software as a compliance problem, the only result is compliance and will spend the minimum possible to get there.  Instead, a company should ask, how can a system build add value the more we use it? With this mindset companies can work with serialization software providers to start to do things early and get to that goal. The more sophisticated serialization and compliance systems are the will enable customers to accomplish these goals and effectively manage a supply chain.

 

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

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

 

Falsified Medicine Directive 4 of 5 – How can L4L5 solution vendors help customers get ready for compliance?

How can L4L5 solution vendors help customers get ready for the Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act (DSCSA)?

L4L5 solution vendors have to be quick and have the ability to make services available for early rollout. Too many times, in this industry we have made engineering tools fantastic, but they are difficult to implement. Tools need to be at the consumer level, simple. The tools have to be intuitive, simple and quick to implement. Easy to validation is key. The Pharmaceutical industry is validation heavy. If a solution vendors system can’t validate, then things can go wrong and disrupt ones supply chain. L4L5 solution vendors need to make it as easy as possible and ideally give an added value. It is such a new concept.

 

If a European Pharmaceutical Manufacturer buys a L4L5 solution vendor for Europe, does that mean they need to purchase other L4L5 solution vendors to fulfil other global compliance regulations?

Many solution vendors are only compliant for very limited geographical areas. Experience solution vendors know what they are doing, have experience with different modules and geographies. And as a pharmaceutical company expands, solution vendors can adapt. L4L5 solution vendors should provide an upgrade to fit customer needs at any point. It is important to pick a solution vendors that can fit your compliance needs now and in the future. An experienced L4L5 solution vendors will consider customers goals for the future. It is important that companies in the supply chain pick L4L5 solution vendors that will help reach those goals from the beginning.

 

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

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

Falsified Medicine Directive 3 of 5 – How to prepare for meeting compliance requirements?

What do European Pharmaceutical companies need to do in meeting compliance requirements in the United States?

They key is to purchase a system that enables the company to pass data on to the regulators in the most accurate and efficient way possible.  All companies in the supply chain have the obligation to report the data to the authority.  Authorities like the Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act in the United States are providing guidelines on meeting compliance requirements.

Companies need to plan ahead and ask providers how they will pass correct data in a way that is consistent, high quality and validated. This is a fundamental change in the way the drug industry currently does business and is crucial in meeting compliance requirements. Before, all things that were manufactured physical objects and in the same a batch. Tomorrow there will be objects are physical but also virtual. Requiring each package to match the data in the box and each pack along the production line is different.

 

What do small companies and virtual manufacturers need to do to prepare?

They need to think about, what resources they will need to get this done. How much bandwidth do they have internally to get this done? When choosing a provider, they need to think about what is my side of the deal. Do I have to employ a project manager? How long will this implementation take and how much will they have to invest in serialization?  The compliance allegation is nonnegotiable, they have to get it done as required by Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act (DSCSA).  It is tricky and complicated challenge but there are dedicated experts to get it done

Big drug companies have teams of people with serialization in their job title, however, some small drug companies, have a one-person team, usually the head of manufacturing. These people wear 15 different hats, they don’t have the time to to get the job done because it is such a complicated process, it would totally consume them.

With rfxcel companies in the pharmaceutical supply chain are meeting compliance requirements in 60 business days. That is a big difference between service providers that stretch it for 5 or 6 months. At rfxcel, we like to take the burden away from the customer and actually help with data validation, data management, managing the training partners and designating teams for meeting compliance requirements. Other providers require them to really get their hands dirty and really get into this which requires companies to allocate more time and resources.

 

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

 

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

Falsified Medicine Directive 2 of 5 – Will the EU Falsified Medicine Directive deadlines be delayed?

Falsified Medicine Directive deadlines are putting pressure on the industry. How to get over the EMVO hurdles and how the member states get over those hurdles?

Big system changes are challenging, especially during the beginning stages. The EMVO is doing a great job of getting their side of the framework. It ultimately comes  down to solution providers like rfxcel and others to help the manufacturer’s do their piece of the bargain. This process is not going to be easy, but it needs to happen for patient safety. The underlying theme of the Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act (DSCSA) is patient safety. The end result will enable drug companies keep their product safe by tracing it. All of it is possible. It is just a matter of allocating the right resources and people who will prioritize the effort.

 

The  US has delayed enforcement for a year for DSCSA how does this impact the FMD?

One can never rule out that a delay or postponement will come because it is always possible. However, experts are not convinced there would be an enforcement delay. A deadline is a deadline. Management needs to take action regardless of there being a delay or not.

The reason there is a delay in the US is that Pharmaceutical companies had a difficulty getting the job done in the time available. This indicates to all of the EU that they should not underestimate the difficulty of the project. The real problem here is serialization isn’t just a manufacturing challenge. It is not printing numbers on bottles. It is a business change program across the whole corporation, and supply chain. When companies implement serialization all departments need to get involved in the project. They have to do a lot of work and a lot of internal coordination to get it done.

 

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

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

Falsified Medicine Directive 1 of 5- What makes rfxcel different?

Falsified Medicine Directive: What makes rfxcel different?

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

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

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

 

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

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

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

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

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

Compliance Quick Reference Guide – CFRTitle21Part11 and EU Annex 11

EU Annex 11 & 21 CFR Part 11 Compliance Checklist

The United States Food and Drug Administration (FDA) and the European Commission have defined regulations for the conditions under which regulated companies can submit electronic records in lieu of paper documents.

These regulations define the measures that must be in place to ensure the integrity, trustworthiness, and reliability of the electronic records.

The regulations define and require three types of controls:

  1. Administrative controls, e.g. the definition of policies such as the identification of individuals and non-repudiation of electronic records.
  2. Procedural controls, e.g. Standard Operating Procedures for using and maintaining the system.
  3. Technical controls e.g. functions built into the software such as security and access to the system as well as the audit trail

For compliance with the regulation, all three of the above controls must be implemented.