Category: whitepapers

Quick Guide to Brazil’s National Medicine Control System (SNCM)

Since 2009, the Brazilian Health Regulatory Agency (ANVISA) has been discussing how control over the circulation of medicines can improve society, either by inhibiting counterfeiting or by reducing theft. According to the World Health Organization, 10% of all drugs sold worldwide are falsified, accounting for approximately $200 billion in lost revenue every year.

ANVISA’s National Medicine Control System (SNCM), slated to go into effect in May 2022, will help companies reduce financial losses, lessen the impact of criminal activities, and help ensure that citizens have access to medicines that did not originate in parallel markets.

rfxcel has prepared a Quick Guide to foster and accelerate understanding of SNCM, including:

• Its key requirements
• Complexities facing the industry
• How to prepare to meet the May 2022 deadline

Download the Quick Guide to learn more.

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Guia Rápido para o Sistema Nacional de Controle de Medicamentos – SNCM

Desde 2009 vem se discutindo sobre as melhorias que o controle sobre a circulação de medicamentos pode trazer para a sociedade – seja por inibir a falsificação quanto para reduzir o desvio de cargas. Segundo a Organização Mundial da Saúde (OMS), de todos os medicamentos vendidos mundialmente, 10% são falsos, o que representa aproximadamente 200 bilhões de dólares em receita por ano.

O Sistema Nacional de Controle de Medicamentos – SNCM da ANVISA vem para ajudar as empresas a diminuírem seus prejuízos e impactos de atividades criminosas, e também para auxiliar e garantir que a sociedade terá acesso aos medicamentos não provenientes de mercados paralelos.

Visando acelerar o entendimento destes requerimentos, a rfxcel desenvolveu este Guia Rápido para o SNCM. Nele você entenderá:

• Principais requerimentos para o SNCM
• Complexidades que a indústria enfrentará
• Preparação necessária para cumprir o prazo de implementação

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

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.

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

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

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.