EnglishFrenchGermanItalianPortugueseRussianSpanish

Verification Router Service (VRS) Update and Overview

Join rfxcel to learn about supply chain management and regulatory requirement:

VRS BASICS
Have No Clue About the Verification Router Service? Contact Us Learn the Basics:
1. FDA/DSCSA Requirements for Saleable Returns
2. An Introduction into the Verification Router Service (VRS)
3. rfxcel’s VRS Pilot Options and Demonstration

OR WANT TO LEARN ABOUT VRS EFFORTS
Understand VRS but Want to Know More? Ask about the Latest Updates on the VRS Efforts:
1. Insight into the Verification Router Service (VRS)
2. Timeline/Updates on the VRS Program
3. rfxcel’s VRS Pilot Findings
4. What’s Next for VRS – Industry Updates

CONTACT EMAIL:

hello@rfxcel.com

About rfxcel:
rfxcel is one of the most tenured track and track provider in the market today. rfxcel provides leading-edge solutions to help organizations meet regulatory compliance requirements, protect their products, and brand reputations. For the last 15 years, pharmaceutical manufacturers, wholesale distributors, and pharmacies throughout the industry have trusted rfxcel to provide more than just compliance solutions; they rely on rfxcel’s platform for greater real-time supply chain visibility and value. rfxcel is located across the globe in the U.S., EU, Latin America, India, Russia, the Middle East and the Asia Pacific. rfxcel’s integrated track and trace software suite delivers better business outcomes and lowers supply chain costs.

Serialization and Validation with rfxcel (Part 3 of 3)

Watch the short interview with Mark and Amit to learn more about our system’s architecture for data quality in a supply chain. Contact us for a quick demo.

MARK DAVISON: Head of Europe for rfxcel Corporation – a global leader in traceability solutions. He has started EU and Russia operations for rfxcel, devising the regional strategy, hiring staff and managing fast growth. He was voted onto Medicine Maker magazine’s Power List of 100 most influential people in pharma manufacturing and development. He has technical expertise in anti-counterfeiting technologies and vendor selection, including authentication, serialization, and traceability.

AMIT SEWAK: Responsible for contributing to the rfxcel’s mission and vision by designing, strategizing, assessing, planning and implementing the performance improvement programs to meet the needs of the organization. He provides leadership and strategy in regulatory, compliance and technical guidance to staff for digital IoT products. He functions as the Management Representative that maintains oversight responsibility for all Quality Management Systems.

Since every system, even a well validated one, is prone to errors that are flowing from outside, Mark and Amit speak about the engineering of rfxcel’s system which is designed to catch as many of those errors as possible.

Over the last three years rfxcel has consistently been able to identify almost 96% of our issues up front, before they get to our customers. Our product has the ability to pick out duplications and transmission errors between fields which other systems pass through. One of the attributes of our system is its monitoring ability which is tailored to your compliance needs.

With rfxcel you can pick a solution which partners with you and allows you to have the growth you need, while the system expands as well.

Serialization and Validation with rfxcel (Part 2 of 3)

Watch the short interview with Mark and Amit to learn more about the compliance factors and requirements that are essential when evaluating a software vendor for serialization. Contact us for a quick demo.

MARK DAVISON: Head of Europe for rfxcel Corporation – a global leader in traceability solutions. He has started EU and Russia operations for rfxcel, devising the regional strategy, hiring staff and managing fast growth. He was voted onto Medicine Maker magazine’s Power List of 100 most influential people in pharma manufacturing and development. He has technical expertise in anti-counterfeiting technologies and vendor selection, including authentication, serialization, and traceability.

AMIT SEWAK: Responsible for contributing to the rfxcel’s mission and vision by designing, strategizing, assessing, planning and implementing the performance improvement programs to meet the needs of the organization. He provides leadership and strategy in regulatory, compliance and technical guidance to staff for digital IoT products. He functions as the Management Representative that maintains oversight responsibility for all Quality Management Systems.

In this interview Mark and Amit discuss what questions you should be asking when evaluating a solution provider for serialization.

There are three key compliance factors you should take into consideration when evaluating software vendors for serialization, according to Amit.

The first one is maintaining your validated statement. If the vendor keeps providing you with continuous updates, you need to constantly validate to maintain the state of compliance which can be a very laborious and costly task.

The second factor to consider is how well the risk is being controlled on your end.  If the vendor keeps providing you with the risk process upfront, you as the recipient can make your own risk decisions.

The third factor to take into consideration is the transparency of the improvements that the vendor makes to the software, keeping you up to date with all the changes and improvements.

rfxcel ensures the transparency for the manufacturers, distributors and dispensers, providing the best quality of data.

Serialization and Validation with rfxcel (Part 1 of 3)

Watch the short interview with Mark and Amit to learn more about managing compliance with various traceability regulations with rfxcel. Contact us for a quick demo.

MARK DAVISON: Head of Europe for rfxcel Corporation – a global leader in traceability solutions. He has started EU and Russia operations for rfxcel, devising the regional strategy, hiring staff and managing fast growth. He was voted onto Medicine Maker magazine’s Power List of 100 most influential people in pharma manufacturing and development. He has technical expertise in anti-counterfeiting technologies and vendor selection, including authentication, serialization, and traceability.

AMIT SEWAK: Responsible for contributing to the rfxcel’s mission and vision by designing, strategizing, assessing, planning and implementing the performance improvement programs to meet the needs of the organization. He provides leadership and strategy in regulatory, compliance and technical guidance to staff for digital IoT products. He functions as the Management Representative that maintains oversight responsibility for all Quality Management Systems.

In this interview, Mark and Amit discuss the issues of managing compliance with various traceability regulations such as sensitivity and protection of the data quality.

Data quality is a process of managing integral parts of your data for your systems, and ensuring that, on a risk- based level, you are containing and controlling that information so unauthorized access is prevented. As a customer, you cannot rely on the system to provide you with full security. That’s where rfxcel steps in and takes it to the next level.

rfxcel provides different procedures and controls that are technical, administrative or procedural that ensure protection of customer’s data. Since it’s a holistic level of management of data and not just an enterprise level, client or system based situation, it’s a crucial aspect for companies to be very sensitive and compliant.

While rfxcel makes sure our customers are compliant, the customer also has a much invested value in ensuring the change control procedures meet standards making the customer an active partner with the vendor in going through change management. We allow our customers the opportunity to stay in a compliant state, thus having control of how your system is being addressed.

rfxcel provides not only procedural and operational guidelines, but also a full support needed in case of a compliance audit.

Value beyond compliance with IoT technology

Watch a short interview with rfxcel’s Mark Davison and Atul Mohidekar to learn more about Value beyond compliance with IoT technology. Contact us for a quick demo and case studies on rfxcel’s IoT technology.

Mark Davison, Senior Operations Director – Europe, rfxcel

Mark Davison started rfxcel’s EU and Russia operations and is responsible for devising regional strategies, hiring, and managing growth. He made Medicine Maker Magazine’s Power List of 100 most influential people in pharma manufacturing and development. Mark provides particular expertise in anti-counterfeiting technologies, authentication, serialization, traceability and vendor selection. Now he broadening his experience about value beyond compliance with IoT technology.

Atul Mohidekar, Chief Technology Officer, rfxcel

Atul Mohidekar is known for his extensive technical expertise in Big Data and is exceptionally skilled in designing highly scalable IoT solutions. Atul is adept at identifying and harnessing data to complement highly configurable IoT devices for event identification and processing for real-time analytics and data mining.

In this interview, Mark and Atul discuss the value of IoT technology to derive value from the vast amounts of data gathered through compliance efforts. Mining the data gathered through compliance efforts provides companies and organizations with the opportunity to gain new insights and complement IoT efforts with on-demand track and trace and event-driven decision making.

rfxcel Traceability Software (rTS) and in particular our Environmental Monitoring solution (rEM) are designed to monitor and track events in real-time and provide information such as location, temperature, humidity, light, and pressure. With the help of rfxcel, companies can track and trace products immediately and gain unprecedented product insights at even the unit level.  This breakthrough in supply chain technologies provides companies and organizations the ability to monitor the health of cold-chain products, deter theft and fraud, optimize supply chain operations, and manage recalls and returns more efficiently.

Watch and learn more today about the exciting new application of IoT to enhance supply chain operations and take them to next level!

Webinar: EU Falsified Medicines Directive

EU Falsified Medicines Directive webinar that will provide insight into the upcoming serialization requirements, and learn how to ensure your organization is on track to compliance. In this 45 minute presentation, we are discussing:

1. An overview of key features of the EU Falsified Medicines Directive.

2. What does this mean for Marketing Authorization Holders (MAHs), Distributors and Dispensers?

3. Who does what? The role(s) of Small or Virtual MAHs and Contract Manufacturers explained.

4. Explanation of the EMVO process, and steps to onboarding your organization.

5. Considerations when selecting a certified gateway provider.

6. Timelines, resource needs, validation and other issues.

 

Please check out the FAQ from the EU Falsified Medicines Directive webinar.
Or copy/paste this link in your browser: https://rfxcel.com/eu-falsified-medicines-directive-webinar-faq/

 

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.

 

For more information contact us.

rfxcel Traceability System – Software Release 6.0

rfxcel Traceability System 6.0:  New Traceability Solution Delivers Improved User Experience and Performance

Request a demo for rfxcel Traceability System

rfxcel, the leader in Life Science track and trace, and compliance systems, today announced the release of rfxcel Traceability System (rTS) 6.0.  The new traceability software delivers increased usability and performance which is powered by the new rTS 6.0 architecture and technology stack.

rfxcel Traceability System 6.0 is built upon an enhanced architecture that provides greater scalability; allowing new features to be quickly added.  The new product gives users improved visibility into their supply chain via a new, highly responsive user interface (UI) and enhanced report features. Better search capabilities, menu navigation, event relationships, event notifications and alerts, and user configuration options have been added as part of the functional and UI improvements.  rTS 6.0 has been further optimized to deliver up to 3X performance improvement for critical processes.

“rTS 6.0’s cutting-edge architecture makes fast, easy data insight a reality for all customers. We’re incredibly proud of the work the rfxcel team has done to deliver this game-changing serialization and compliance technology, and most importantly, make it a seamless upgrade for our customers. rfxcel brings increased visibility and flexibility to supply chain traceability and product serialization, making data more assessable than ever before.” – Atul Mohidekar Chief Technology Officer at rfxcel.

The rTS 6.0 platform is designed to simplify and accelerate how customers can meet their compliance, serialization and track and trace requirements. By leveraging a new architecture and optimization techniques, customers can be confident that their investment will meet their current obligations and scale to meet their future needs.

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.

rfxcel Implementation Plan (Part 7 of 7) – Switching Serialization Providers

Switching Serialization Providers – Learn more about the process of switching to rfxcel’s serialization implementation plan:

About the speakers:

Rose Campasano, Vice President of Professional Services at rfxcel, is a collaborative leader with over 20 years of IT leadership experience encompassing infrastructure, applications, and business processes. She focuses on nurturing long-lasting, trusted partnerships with rfxcel clients and their integration partners.  She excels at employee motivation and coaching demonstrated by a high performing team.

Herb Wong, Vice President of Marketing at rfxcel, is responsible for defining the rfxcel product roadmap and marketing strategy. He also ensures the coordination of rfxcel’s marketing message and product offering and provides leads and collateral for Sales team members.

In the final segment of the interview, Rose and Herb explain the process of switching between serialization providers and how the process is conducted by the rfxcel team.

There isn’t much difference between starting a brand new implementaion process and replacing the existing one. The reason for this is that we have a good understanding of nearly all the other existing serialization partners since we have been working with them for two years. Because we have worked with them on the daily basis, our team knows their software as well as our own. It is therefore easy to transition into our software, which we have successfuly done a number of times.

„We’ve been doing this for so many implementations already. We have a standard set of documentation that we’re using. We have templates. We have a set of user requirements that are well defined for the industry it actually works. At the kick off meeting we’re already bringing you a development system that looks like your system,” says Rose.

In essence, we have all of the validation documentaion already prepared and we’re building further based on your specific configuration. We are able to show you at the very start that the half of the documentaion is alrady going to be in your hands in the first week.

rfxcel Serialization Implementation Plan is easily configured according to your specific needs and demands. Our team is with you through every step of the process and we offer support during the entire time you are using our services. To help you get a detailed idea of our Serialization Implementation Plan, we have discussed our Plan in seven segments:

  1. Serialization Implementation Plan based on Audit Needs
  2. Boost Serialization Implementation with a Global Team
  3. Global Serialization Implementation Team for Global Customers
  4. A Serialization Solution Provider Focused on the Long Term Relationship
  5. Common Challenges in Serialization Implementations
  6. Implementation kick off with rfxcel
  7. Switching Serialization Providers

 

Switching Serialization Providers with rfxcel