For more than a decade, OPTEL’s L4-L5 serialization software, a patented, enterprise-level serialization and traceability solution, has been helping the world’s best-known brands protect their assets.
Level 4 – the enterprise level – provides various functional areas to handle an assortment of business processes, global compliance, inter- and intra-organizational connectivity, reporting, identity access management and application programming interfaces. In a nutshell, the warehouse is connected to the corporate serialization management system, wherein details about the product are included and saved.
Three Important Points in L4:
Level 5 is generally considered the network level. It manages all serialization and regulatory data with all the parties involved such as partners, authorities and customers. This level is basically outside or above the enterprise. This can be the network of supply chain partners, a shared event repository, regulatory authorities such as national hubs or international repositories like the EMVS in Europe, or the repository to be put in place by ANVISA in Brazil. Your Level 4 system will feed information to Level 5 to allow external access to data. Given that your serialization data will be transferred outside your local network, your serialization solution will need to be able to handle all common standard data exchange formats (e.g., EPCIS) to ensure correct data transfer and at the same time provide maximum data security and access control. To make matters more complicated, you don’t only need to comply with serialization regulations but also consider data protection laws applicable to the countries in which you operate.
An effective serialization solution therefore must process data from across all levels. Data must be connected and shared from the packaging line to the enterprise level, supply-chain partners, points of sale and, where required, to authorities.
Government authorities all around the world are defining and implementing regulations with which the pharmaceutical industry must comply
Verify Platform is an essential software to comply with most international pharmaceutical regulations such as DSCSA, European Medicines Agency, ANVISA to name a few.