OPTEL's L4-L5 serialization and traceability solution

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

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:

  1. Serial number management
  2. Site management (Site data connected to L4 for report management)
  3. Compliance in reporting (National regulatory and product compliance). Details of the products need to be provided, and certain countries ask for compliance reports at the time of purchase or after the purchase.

Level 5

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.

Benefits of OPTEL

  1. OPTEL is the only company with the ability to provide full-stack, true end-to-end traceability.
  2. Other L4-L5 solution providers need to go through partners or third-party connections to government agencies to collect data, which often leads to failure points and lower data security.
  3. OPTEL’s L4-L5 solution uses the GS1 universal standard and supports EPICS (1.0, 1.1, 1.2) to ensure greater connectivity by standardizing the communication format and therefore optimizing partner integration.
  4. All data required by national regulations are stored and communicated through OPTEL’s Verify Platform software.
  5. OPTEL is one of a handful of serialization providers that can offer companies doing business in serialized countries a direct connection to government regulators and payers.
  6. OPTEL has already implemented solutions for Russia and Europe, and has a solution ready for South Korea, Turkey and Saudi Arabia, although regulatory compliance is yet not in place in these countries.
  7. OPTEL has L5 solutions to meet Russian compliance requirements. OPTEL will send data to NDLC; ERPT, the company assigned by the Russian government, will confirm with NDLC before final approval.
  8. For Europe: OPTEL sends data to EMVS; DMGO, the company designated by the European government, will verify before final approval.
  9. China also has regulations, but they have not assigned any company to manage compliance. The government will make the L5 platform that would be state-wide and then connected across the country.

REGULATIONS AROUND THE WORLD

Government authorities all around the world are defining and implementing regulations with which the pharmaceutical industry must comply

TrackTrace

VERIFY PLATFORM

Verify Platform is an essential software to comply with most international pharmaceutical regulations such as DSCSA, European Medicines Agency, ANVISA to name a few.

SPEAK TO OUR EXPERTS