The Different Levels of a Serialization Solution
Serialization experts like to talk in levels. This helps them to break down and define the different components of serialization solutions and customer needs. But what do these levels actually stand for and what’s happening on each of them? And, do we all speak the same language when it comes to these levels?
Serialization and the ISA-95 Norm
Widely used by serialization experts is a norm called ISA-95, a standard developed by the International Society of Automation. This standard was originally invented to be applied in all industries, and in all sorts of continuous and repetitive processes. For example, packaging and serializing products.
If we apply the ISA-95 norm to a packaging line, the Levels range from 1 to 4 or sometimes 5. Hence, when discussing Track, Trace, and Serialization, we often discuss hardware and software in terms of Level 1, Level 2, Level 3, or Level 4 and 5.
The five levels of a serialization solution
Level 1 of a serialization solution according to ISA-95 is the device level. Common devices on a packaging line are barcode printers, label printers and labelers to allow serial numbers to be fixed on units of sale/packaging. Cameras and scanners help control the quality of the printed barcodes and other information. And so forth.
Level 2 of a serialization solution takes care of case or packaging line automation and control, serving to aggregate data across all of the Level 1 devices.
Level 3 of a serialization solution means all the site level systems. These systems typically facilitate communication between Level 2 systems within a site and connect to Level 4. Level 3 manages and coordinates master data, serialization of products, product and work order information, etc. For more information on the must-haves of a robust Level 3 solution, download our whitepaper on “The importance of Level 3 applications”.
For your information, Adents Seriza is a good example for a Level 2/3 software solution: Adents Pilot on level 2 controls and monitors all Level 1 devices whereas Adents Supervisor manages serialization data and more and is the gateway to Level 4 systems.
A Level 4 system provides various functional areas to handle an assortment of business processes, global compliance, inter and intra-organizational connectivity, reporting, identity access management, application programming interfaces, and other enterprise-level functional areas. Learn more about what a good Level 4 system needs to be future-proof in our FREE WEBINAR “Cloud serialization and traceability solution (level 4-5): value beyond compliance”.
Level 5 is generally considered the network level, 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 for example or the repository to be put in place by ANVISA in Brazil. Thus, a level 5 network facilitates management of all serialization and regulatory data with partners, customers, and authorities. Your Level 4 system will feed information to the Level 5 to allow external access to data. Given that your serialization data will be transferred outside your local network, your serialization solution will have to be able to handle all common standard data exchange formats (i.e. EPCIS) to ensure correct data transfer but at the same time provide maximum data security and access control. To make matters more complicated, you don’t just have to comply with serialization regulations but also take into account data protection laws in the countries you operate in.
An effective serialization solution therefore has to process data from across all levels. Data must be connected and shared from the packaging line to the enterprise Level, supply-chain partners, point of sale and, where required, to authorities. The Levels can be implemented separately, but if you do so, you need to be very careful which sort of solution you use for level 1-3 and 4/5. Applying commonly used standards for the supply chain and agnostic Level 4/5 solutions such as Adents Prodigi will help ensure interoperability.
Definition is key for successful serialization projects
However, as useful as dividing a solution up into different levels is, the, rather theoretical ISA-95 norm is not systematically used in practice throughout the pharmaceutical industry and even institutions like GS1 and EFPIA have their own jargon. This, of course, can lead to costly misunderstandings when you are trying to implement a serialization solution or to assess different offers. So in order to ensure that you take all your needs into account and that the different suppliers can make adequate offers you need to ensure that you all speak the same language. Whether you are a pharmaceutical company, a CMO or a serialization consultant, you need to first and foremost clarify vocabulary to ensure that all parties (clients and suppliers) clearly understand each other. Only then will you be able to ensure a successful project life cycle and implement the perfect serialization solution that exactly meets your/your client’s needs.