![]() Centralization and secure connectivity is a must. User Interface: The user interface (UI) must be clean, crisp, modern, and responsive to the existing system’s dimensions-meaning it should be 100 percent responsive for mobile phone usage and “scale up” for large monitor displays.Ĭentralized Location: A chief concern at Level 4 is providing functional areas to handle business logistics. What Are the Elements of a Level 4 Solution? Perhaps the most accurate and succinct definition of a Level 4 system is that it manages the business-focused activities of manufacturing, warehousing, and distribution. The core principles of a Level 4 system make it uniquely positioned to deliver data-sharing capability up, down, and across the supply chain.Įssentially, a Level 4 system consists of a variety of functional areas for handling an assortment of business processes, global compliance, inter- and intra-organizational connectivity, reporting, identity access management, application programming interfaces, and other enterprise-level functions.Ī best-in-class Cloud serialization and traceability solution should use multiple standard data exchange protocols, exchange patterns, data security, and data integrity techniques. While Levels 0-3 are connected to plant/site operations, Level 4 is referred to as the “Enterprise Level.” These sorts of Cloud-based solutions can be thought of as a viewing portal into a specific portion of the overall supply chain.įrom manufacturing to dispensation, the full gamut of stakeholders benefits from sharing information at various points throughout a product’s lifespan. ![]() The most effective and comprehensive serialization solutions support the requirements of all levels of technology, connecting challenges at the plant/site levels with the enterprise level. ![]() ![]() ![]() Drug Supply Chain Security Act-the deadline for pharmaceutical companies and CMOs to deploy full-scale serialization-scheduled for enactment this November, and a similar EU mandate just two years away in 2019, comprehensive serialization efforts are in full swing on both sides of the Atlantic.Ī complete serialization solution is composed of various software and hardware components, each focused on an area of responsibility referred to as a ‘Level.’ According to ISA95, there are five levels of track, trace, and serialization technology, consisting of Levels 0-4. The core principles of a Level 4 system make it uniquely positioned to deliver data-sharing capability up, down, and across the supply chain. ![]()
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