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rfxcel VRS PILOT PROGRAM & INDUSTRY UPDATE

The rfxcel VRS Pilot program to the public started in mid 2018. rfxcel has been the first solution provider in the US to implement and pilot the DSCSA Verification solution for wholesale distributors and manufactures. Due to our success, we have a number of test results and success to help trading partners meet DSCSA 2019 requirements.

With a single 2D barcode scan, the rfxcel Verification Router Service (rVRS) solution verifies serialized products in one second. rfxcel follows the GS1 Verification Messaging standards. By following this messaging framework for asking verification questions and receiving actionable information that immediately enables the requesting party to determine whether to accept, reject or quarantine a product instance.

This rfxcel Webinar gives you a full industry overview as of February 2019. If you would like to receive access to the webinar recording, please email us at: rfxwebinar@rfxcel.com

By downloading a copy of the webinar presentation, you’ll review the following:
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

rfxcel Verification Router Service (rVRS) will ensure wholesale distributors and manufacturers meet the FDA DSCSA November deadline for handling saleable returns. You can still join the rfxcel VRS pilot program. Please contact us here.

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.

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DSCSA VERIFICATION (VRS BASICS) | rfxcel

DSCSA VERIFICATION: Starting in November of 2019, the FDA will start requiring that wholesale distributors verify the product identifier before re-distributing saleable returned products. With the use of a Verification Routing Service (VRS), distributors will be able to rout the serialization data to manufacturers.  In this case, when a saleable return is received, the distributor sends the product data to the third-party routing service, which then routes the information to the manufacturer.

Based on the Healthcare Distribution Alliance (HDA), a DSCSA Verification – VRS is an interoperable solution used to manage the acceptance, formatting and delivery of requests and responses in order to support DSCSA verification requirements and other business requirements as defined between trading partners.

In this webinar presentation document you’ll learn about the following VRS activities:
To get copy of the webinar recording please email us rfxwebinar@rfxcel.com

  • Accept information from an authorized Requestor via an interface or manual entry using a VRS portal. This information is called Product Identifier (PI).
  • The Requester will provide the Global Company Prefix (GCP) or Global Trade Item Number (GTIN)
  • With the GCP or GTIN you determine the routing location to where the verification will be submitted.
  • Verification request is sent to Responder’s master database/system directly or to a VRS used by the Responder
  • After the response is obtained, the requestor will be able to view he data and view an electronic record.

The idea is that when a return occurs, a distributor would scan the data matrix, format and send the verification request to the VRS provider. By the use of master data which is called a Lookup Directory (LI), the request is routed to the right source. The verification request goes to the manufacturer to check if the PI is present. The request is verified if the PI is present in the database. If not, then both parties need to investigate where the issue might be.

rfxcel designed, built and tested a DSCSA Verification VRS solution for wholesale distributors and manufacturers. At the moment we have multiple pilot programs running. With the help of the industry, customers, multiple testing and feedback, rfxcel is planning for a final refinement in spring of 2019.


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.

Follow Us LinkedIn.

Countdown to Complying with the Serialization Requirements of the Falsified Medicines Directive

Winning the numbers game: Countdown to complying with the serialisation requirements of the Falsified Medicines Directive

The Falsified Medicines Directive’s (FMD) February 2019 deadline is fast approaching. Those who don’t serialize by this deadline will be unable to sell their products in Europe.

The regulations set forth by the FMD state that every Marketing Authorization Holder (MAH) must upload serialization codes to the European Medicines Verification Organization.

But serialization isn’t a straightforward numbers game, and not all solutions are created equal. rfxcel has provided this document to help you determine how you need to serialize and what you need out of your serialization partner.

Serialization is a daunting, frustrating journey, but having the right solution and the right partner can make a world of difference.

This document aims to help you:

  1. Understand the regulation
  2. Identify the right partner for a serialisation solution
  3. Take these actions

A Quick Guide to The EU Falsified Medicines Directive

A Quick Guide to the EU Falsified Medicines Directive

It’s a time of rapid change for the pharmaceutical industry—new procedures, laws, requirements, strategies, and technologies challenge us to engage with our products in the supply chain like never before. Many of these changes provide new visibility into the pharmaceutical supply chain to help protect patients.

The EU Falsified Medicines Directive (FMD) is one example of these changes. To help accelerate the understanding of this requirement, rfxcel has provided a Quick Guide to EU Falsified Medicines Directive to help you understand:

  1. The Key Requirements of the EU FMD
  2. Complexities Facing the Industry
  3. Preparing to Meet the Deadline

Compliance Checklist – CFR Title 21 Part 11 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.

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.

Key Industry Terminology

Key Industry Terminology

rfxcel is the leading enterprise software for supply chain and traceability. Major pharmaceutical companies, independent CPOs/CMOs, and wholesalers rely on rfxcel’s expertise in compliance software and support. rfxcel has specialized in core pharmaceutical areas including compliance, tack and trace, serialization and environmental monitoring. Along with a global team and strategic partnership with Verizon, rfxcel has become the #1 independent traceability solution . rfxcel supports its customers in their decision making with rfxcel’s unique 360° approach encompassing capabilities covering global and local markets. rfxcel is committed to its primary mission of supporting customers needs regarding compliance regulations. With absolute visibility into customers’ products, rfxcel is provides value beyond compliance, improving patient safety, customer control and peace of mind.

Seven Secrets of Serialization

Seven Secrets of Serialization

Do you know what’s happening to your products out there in the global marketplace? That knowledge could be the difference between security and vulnerability for you and your customers. Traceability has become a key tool for quality improvement in several industries and is a vital weapon in the war against counterfeits. Your supply chain peers tell us that implementing and managing traceability or serialization software is one of their key concerns. It is indeed a challenge but by learning from their experience, and using an experienced vendor, it doesn’t have to be as difficult as you think.

At rfxcel, we design software systems to handle supply chain traceability in fast-moving, highly regulated and fully validated environments like the pharmaceutical industry. In this short white paper, we’ll share some of our design philosophy and some practical things we’ve learned along the way during customer implementations.