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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.