Level 4 Serialization Explained
The core principles of a Level 4 system make it uniquely positioned to
deliver data-sharing capability up, down, and across the supply chain.
By Christophe Devins and Chuck Sailer of Adents
With the U.S. Drug Supply Chain Security Act—the deadline for pharmaceutical companies and CMOs to deploy full-scale serialization—
scheduled for enactment this November (with a
year-long enforcement grace period to follow), and
a similar EU mandate just two years away in 2019,
comprehensive serialization efforts are in full swing
on both sides of the Atlantic.
A 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 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.
What Is a Level 4 System?
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.
From manufacturing to dispensation, the full
gamut of stakeholders benefits from sharing
information at various points throughout a product’s
lifespan. The core principles of a Level 4 system
make it uniquely positioned to deliver data-sharing
capability up, down, and across the supply chain.
Essentially, 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.
A best-in-class cloud serialization and traceability
solution should use multiple
standard data exchange protocols,
exchange patterns, data security,
and data integrity techniques.
Perhaps the most accurate and
succinct definition of a Level 4
system is that it manages the
business-focused activities of
What Are the Elements of a
Level 4 Solution?
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.