Mark Davison, EU based serialization expert for rfxcel, discusses serialization and added value beyond compliance in the pharmaceutical industry. He has been in the pharmaceutical serialization and track and trace industry for over 10 years and has seen serialization evolve in the pharmaceuticals supply chain. After all these years, companies are discovering the added value beyond compliance of certain implementations and certain serialization software solutions over others.
He provides insights regarding compliance and serialization programs for complying with the law and the specific jurisdictions in the E.U. Falsified Medicines Directive (FMD) and the U.S. Drug Supply Chain Security Act (DSCSA). The discussion focuses on added value beyond compliance, business benefits and using data beyond compliance.
Let’s start by focusing on the basic question such as, What does serialization actually mean?
Many companies believe all they need to do is add a unique identifier to products to comply with the regulations. Serialization seems simple, but beneath the process, things get difficult. Complexity and depth start when integrating trading partners. However, intelligent integration with the help of an experienced serialization solution provider can reduce business risk, magnify supply chain visibility and business value.
Further, products in supply chain change different ownership. Thus, brand owners need to manage the data that is associated with that unique entity. The difficulty continues with verifying data for full integrity as it passes through different ownership. This is why you need to think very carefully about who you trust to manage these risks on your behalf and who your serialization solution provider needs to be.
Ensuring products stay accurate in the supply chain should be your main priority. The FDA and other global regulatory bodies are emphasizing the importance of accurate and reliable data in ensuring drug safety and quality. With the increase of the pharmaceutical supply chain resolution comes a big risk of bad data. At rfxcel, we ensure every event is checked and verified for you to avoid these issues in today and in the tomorrow.
Mark touches how rfxcel’s track and trace solution focuses on data processing to achieve data accuracy.