How to Serenely Achieve Global Pharma Serialization Compliance
Written by The Adents TeamThere are many risks that need to be considered and pitfalls to be avoided when implementing a pharma serialization solution. But, based on agile IT architecture, serialization and track & trace systems can even offer opportunities beyond compliance for the pharmaceutical industry and leverage the business potential of serialization data once regulatory requirements are satisfied.
Achieving pharmaceutical serialization and track & trace compliance requires a lot of time and effort as well as investment. However, with the right serialization solution and a knowledgeable vendor, you can keep pain points to a minimum. But what is the right serialization solution for the pharmaceutical industry and what should be taken into account when choosing one?
The ideal L3 pharma serialization solution is centrally configurable
Centrally configurable site-level serialization solutions minimize impact on OEE, save time, and keep you flexible for future pharma serialization mandates. Level 3 serialization solutions for the pharmaceutical industry like Adents Seriza streamline and centralize information at site level, offering visibility and reactivity at site-level and a gateway to enterprise-level solutions. These systems typically facilitate communication between Level 2 systems within a site and offer a gateway to Level 4 solutions. Level 3 manages master data, ensures unique serial numbers at site level, coordinates work order information, and offers general visibility on all production lines. Central configuration provides for unlimited flexibility when it comes to changing serialization regulations and new markets with next to no impact on Overall Equipment Effectiveness at line-level during change-overs. New pharma serialization regulations or regulatory changes can be configured at site level to be then communicated to the different lines. This avoids hard coding at each and every line, saving time and minimizing risk for human error at line level.
Level 4 pharma serialization solutions for unique serial numbers at enterprise level
Level 4 serialization solutions centralize information at the enterprise level meaning they guarantee unique serial numbers and avoid duplicates across an organization, no matter how many internal sites and CMOs the company works with and no matter their serial number generation strategy.
Through different connection options, flexible enterprise-level serialization solutions for the pharmaceutical industry like Adents Prodigi offer unique platforms for secure data exchange with a multitude of production sites or CMOs, stakeholders, supply chain partners and, where necessary, authorities. Adents Prodigi, for instance, is an official EMVO gateway provider, and the first to participate in the HDA Origin certification process. Adents is also in the process of setting up connection with the Russian Hub [LINKS: relevant press releases for EMVO, HDA and Russia, when available]. Scalable Level 4 pharma serialization solutions based on secure Cloud services such as Microsoft Azure also help cope with the immense amount of data generated through track & trace processes all the while providing for complete control and data integrity at all times.
There are many risks that need to be considered and pitfalls to be avoided when implementing a pharma serialization solution. But, based on agile IT architecture, serialization and track & trace systems can even offer opportunities beyond compliance for the pharmaceutical industry and leverage the business potential of serialization data once regulatory requirements are satisfied.
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