Level up! Adents talks Level 4 serialisation and its unique positioning for data sharing

With serialisation efforts in full swing connecting the dots across the full supply chain is becoming important. Here, Christophe Devins, CEO and co-founder of Adents, and Chuck Sailer, a serialisation solutions expert for Adents, explain why Level 4 serialisation is uniquely positioned for data sharing.

With the US Drug Supply Chain Security Act (DSCSA) scheduled for enactment this November, and a similar EU mandate just two years away in 2019, comprehensive serialisation efforts are in full swing on both sides of the Atlantic.

A complete serialisation solution is composed of various software and hardware components, each focused on an area of responsibility referred to as a ‘Level’. According to ISA95 standard, there are five levels of track, trace and serialisation technology. 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.

While an extensive amount of effort has been expended on line-site implementations in a ‘bottom-up’ approach, it is now critical to connect the dots with sufficient infrastructure both at the enterprise level and along the ensuing supply chain. Indeed, from manufacturing to dispensation, there is a great need to exchange information between trading partners and stakeholders — at any level of the supply chain — to address both regulatory requirements and business operations. In that regard, the core principles of a Level 4 system make it uniquely positioned to deliver data sharing capabilities up, down and across the supply chain.

What is a Level 4 System?

While lower levels 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 benefit from sharing information at various points throughout a product’s lifespan.

Essentially, a Level 4 System consists of a variety of functional areas for handling an assortment of business processes, global compliance, inter- and intra-organisational connectivity, reporting, identity access management, application programming interfaces and other enterprise-level functions. A best-in-class cloud serialisation 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 manufacturing, warehousing and distribution.

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% responsive for mobile phone usage and ‘scale up’ for large monitor displays.

Centralised location: A chief concern at Level 4 is providing functional areas to handle business logistics. Centralisation and secure connectivity is a must. It is common for various user and system roles within a given organisation to require access to various functional areas or APIs provided by Level 4.

For example, warehouse and distribution centre workers will 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. In this scenario, without a proper Level 4, warehouse workers and distribution center workers would be operating on different networks and unable to share important data. Therefore, the Level 4 system is centrally located and accessible by authenticated and authorised users and systems.

Security: Identity Access Management (IAM) plays a critical role in this requirement. 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 the data. This mandate will likely also be included in pending EU stipulations.

Auditing: It is critical that all Level 4 actions taken by any actor (human or electronic) be audited. Audits include actor identifiers, dates and times, underlying objects changed and values before and after change.

Centralised logging: This describes the ability to collect and centralize logs from site-wide Level 3 systems as well as the Level 4 system itself, and to provide insight into that data. Centralized logging provides valuable, system-wide usability metrics and faster problem resolution. Centrally locating logs is the first step toward using newly mined data for competitive production/business advantages.

Message intermediation: Level 4 is where message interoperability between two or more systems occurs, transforming AJAX into XML, XML into CSV, or one XML format into another XML format before data is moved to another system.

How do Level 4 Systems help ensure global compliance?

Government laws and regulations come and go, and are subject to changes. DSCSA, SFDA, Turkey, Europe, Argentina, Brazil, South Korea and India all have very different requirements. Therefore, a certain amount of flexibility must be factored into any system, Level 4 or otherwise, to meet these demands.

Some governments require systems to send properly formatted data directly to a central system. Others take a more manual approach such as email of (S)FTP. Whatever the case, the Level 4 system must be able to accommodate. Regardless the workflow scenario, there must be a suitable facility within Level 4 to record actions.

Here, the ability to inspect the aggregation of a batch/lot or object identifier, such as an SSCC or SGTIN, is vital. This process entails a variety of identifiers, including:

a. Disposition

b. Packaging level (pallet, case, item, etc.)

c. Genealogy (children, parent, grandparent, etc.)

d. Last known location (GLN or LAT. LONG. pinned on a mapping API)

e. Current location (GLN or LAT. LONG. pinned on a mapping API)

Serial number management: Although Level 4 isn’t the primary stage for recording product serial numbers, some degree of serial number management at Level 4 is useful — depending on the specific serialisation recording system being used.

For example, if a manufacturer uses a solution from our company called ‘Adents Supervisor’, this system would be its ‘system of record’ for serialisation numbers. Here, it is useful for the Level 4 solution to review serial number ranges to inspect and audit Supervisor’s issuance of serial numbers. It is also desirable to have the Level 4 system configure serial numbers and communicate new and updated information back to the Level 3 system.

Business processes: Any Level 4 system should be able to execute business processes, defined as any problems that a customer must solve to be compliant with government regulations and/or their own standard operating procedures. Examples include packing, shipping, dis-aggregation, global compliance reporting, printing and sending/receiving files or data to and from other systems.

Label printing: In a warehouse or distribution centre, it is not uncommon for labels to get destroyed, or for rework to occur requiring additional label printing. Therefore, a Level 4 solution that assures compliance must accommodate instances of both reprinting and, should a revised serial number be required, new label printing.

Reporting: Reports are always a requirement in any enterprise level software system and can be thought of in two classes — industry reports and customer driven reports.

The cloud fit and Level 4

There are advantages to deploying any modern system to the cloud, including high availability, unlimited scalability, durable storage, database management (including identity access segregation) and metrics mining (i.e., big data) capabilities.

All these features and capabilities are desirable in any enterprise application. The cloud makes them a reality with very little effort and at a tremendous cost savings when compared to onsite physical hardware alternatives.

Data integrity, security, and resiliency benefit greatly from built-in features of the Cloud infrastructure. Data centres thousands of miles apart can be set up in minutes. Multiple data centres ensure data is protected from loss, and is available to all dependent applications. Backing up, restoring, and ensuring consistency among data centres is clean and concise.

Another benefit of the cloud is the maturation of DevOps. Building, testing and deploying software on the cloud can follow predictable and repeatable processes that were not easily achievable just a few years ago. Principles and practices of solid DevOps methodologies ensure a high level of quality and dependability.

New and exciting digital paradigm

Clearly, cloud technology (Level 4) presents many advantages for pharma companies to manage compliance globally in terms of data generation, exchange, storage and security. However, the real value goes beyond compliance. Cloud technology will be the cornerstone of the digitisation of the supply chain.

Coupling Level 4 serialisation and track & trace systems with business intelligence tools and Industry 4.0/IoT will accelerate the digital transformation of the supply chain and allow the pharmaceutical industry to develop new capabilities, such as end-to-end collaboration, granular supply chain visibility and data-driven decision making.

Imagine this — patients who have the potential to access full product information, including origin and authenticity, as well as the capability of manufacturers and trading partners to monitor the supply and plan logistics down to the unit-level to avoid disruptions, manage adverse events and improve profitability. Clearly, Level 4 systems are at the heart of a new and exciting digital paradigm for manufacturers, trading partners and patients.