regulatory-compliance for pharma and biotech products

Data Matters in Serialization (Part 4 of 6) – A Serialization Software for Regulatory and Compliance Requirements & Beyond

It’s important to choose a vendor that has the people and the software to provide you a complete serialization and traceability solution. rfxcel’s implementation specialists have the knowledge and technical background to integrate into various systems you need. Mark Davison, the EU based serialization expert for rfxcel, continues the discussion with an emphasis on choosing a track and trace solution that is more than meeting the regulatory compliance for pharma and biotech products (Learn more about rfxcel Regulatory Compliance Software). It is one of the last mentioned topics in the serialization meeting but takes a lot of time when implementing and deploying the system.

The modern pharmaceutical supply chain is not the monolith it was 50 years ago. Most drug companies don’t make their own product, in most cases they outsource resources including their packaging. This causes most companies to have multiple business partners that have to be involved in the supply chain and ready to exchange data.

The process of data exchange both to and from systems will impact the implementation process once a serialization provider is selected.  It is crucial that the solution provider has a clear understanding of business partners, data processing and a company’s overall requirements for reporting the data throughout the business partner network. How a company manages that process could mean the difference between an easy and difficult implementation.

rfxcel develops simple interfaces to help prepare companies and partners for quick and efficient implementation.  Thinking of requirements for your system is a great start for a clear and fast start with your project management team at rfxcel. And it will maximize data validation process in the software that you don’t have to do later.

Data validation is absolutely critical in serialization and one of the trickiest things to get right. In the Pharmaceutical serialization, the law is pretty clear in most major jurisdictions about how you have to validate the data and in fact, good automated manufacturing practice from the International Pharmaceutical Engineering is pretty clear on how companies should go around validating a system in specific ways. Not only do rfxcel teams work with your partners, they understand U.S. Drug Supply Chain Security Act (DSCSA) or the E.U. Falsified Medicines Directive (FMD) so companies don’t have to worry about them.

There are many ways that companies take shortcuts with cloud-based systems. These shortcuts work well that some environments but not so well in highly regulated pharmaceutical supply chain environments. A heavily regulated and validated environment requires a company to prepare for audits and heavy fines that come with poor data reporting.

At rfxcel, we understand this risk, so we emphasize a secure and stable system that is reliable; day after day, week after week. It is not a one-time implementation and one time fix, it is a lasting solution that is reliable and stays up to date with the evolving supply chain regulations so you don’t have to worry about it.