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Level 4 Serialization System Offers a Transformative Promise

A Level 4 system has the potential to usher in a new era of supply chain efficiency, transparency and compliance.

Level 4 systems are at the heart of a new and exciting digital paradigm for both manufacturers and consumers.
Level 4 systems are at the heart of a new and exciting digital paradigm for both manufacturers and consumers.

Comprehensive serialization efforts are in full swing on both sides of the Atlantic. Even with the FDA’s recent issuance of a one-year delay in enforcement of the U.S. Drug Supply Chain Security Act to Nov. 26, 2018, the DSCSA law does not change.

To be considered truly comprehensive, serialization solutions need to support the requirements of all levels of technology. According to ISA95, there are five levels of track, trace, and serialization technology—Levels 0 to 4—and the most comprehensive solutions, which consist of both hardware and software, connect all levels.

The promise of a Level 4 system

While Levels 0 to 3 are connected to plant/site operations, Level 4 is referred to as the “enterprise level,” where cloud-based solutions provide a portal into the overall supply chain. From manufacturing to dispensation, all stakeholders benefit from sharing information at various points in a product’s lifespan. The core principles of a Level 4 system position it to deliver on its promise to enable data sharing up, down, and across the ecosystem of trading partners, working together to bring products to market.

The ability to share information securely and near instantaneously, coupled with serialization and the unique identification of each product, is what makes true traceability possible. A Level 4 system has the potential to usher in a new era of supply chain efficiency, transparency and compliance. We have entered the era of the digital supply chain—the transformation it will drive has just begun.

Elements of a Level 4 system

A best-in-class Level 4 system uses multiple standard data exchange protocols, exchange patterns, data security and data integrity techniques.

User interface (UI): The UI must be clean, crisp and modern, and responsive to the existing system’s dimensions. It should be 100% responsive for mobile phone usage, and “scale up” for larger monitor displays.

Centralized location: Centralization and secure connectivity are important at Level 4, as it is common for various user and system roles within an organization to require access to various functional areas or APIs. For example, warehouse and distribution center workers need to perform business processes on data collected at the packaging line (Level 2) and aggregated by a site-level system (Level 3). Before these workers can do their jobs, Level 3 must send relevant data to Level 4. Without a proper Level 4, warehouse workers and distribution center workers would be operating on different networks and unable to share important data. The Level 4 system must be centrally located and accessible by authenticated and authorized users and systems.

Security: Identity Access Management (IAM) is critical, as not all actors—whether human or electronic—will have the same access to Level 4 functionality and API operations. A secure Level 4 will use Multifactor Authentication (MFA), Certificates, API Keys, and HTTPS, at a minimum.

Electronic signature: FDA Regulation CFR 21 Part 11 clearly states that all changes within systems dealing with pharmaceutical operations must record electronic signatures for any changes made to data.

Auditing: It’s critical that all Level 4 actions taken by any actor be audited. Audits include actor identifiers, dates and times, underlying objects changed, and values before and after change.

LAST CHANCE TO SAVE! New Tech for Life Sciences at PACK EXPO Southeast
The exciting new PACK EXPO Southeast 2025 unites all vertical markets in one dynamic hub, generating more innovative answers to packaging challenges for life sciences products. Don’t miss this extraordinary opportunity for your business!
REGISTER ASAP FOR $30!
LAST CHANCE TO SAVE! New Tech for Life Sciences at PACK EXPO Southeast