The stages below illustrate an excellent starting point for planning your serialization program, but should not be considered all inclusive. As with any program, the emphasis is on the planning stages – planning is critical in the serialization space. Time is of the essence. No manufacturer can afford to commit to a pilot and discover that the system you’ve been working with doesn’t have the proper backup capability in case of a power outage, or any other unforeseen situation.
Where are you now?
- Identify stakeholders – Operations, Legal, Distribution, Labeling, Regulatory, IT, Engineering, Purchasing, Customer Service, Quality, etc. – and establish your team.
- Detail your product portfolio (identify which SKUs are required to be serialized and which are exempt), package configuration (bottle, carton, etc.), and packaging line configuration/equipment/print technology, IT infrastructure, etc.
- Be aware of DSCSA definitions for manufacturer, distributor, CMO, etc. and know if your products are potentially exempt.
- Map all of your current business processes impacted by serialization.
- Review level of GS1 adoption. Define business objectives.
- Review method for sharing transaction data (transaction information, history and statement).
- Define process owners and responsibilities of potentially separate systems.
- Define current IT capabilities.
- Identify current processes to identify and quarantine suspect/illegitimate products.
- Define scope, schedule and budget (pilot and rollout)
- Determine internal and external resource requirements
- Determine IT infrastructure for operations, backup and recovery, and risk of data breach (site server or other)
- Evaluate and select serial number management system and serialization provider (floor through enterprise)
- Design scalability and flexibility into your solution
- Determine and procure required equipment, hardware and software
- Determine print technology and coordinate with CMOs
CRB’s serialization efforts for the lines above have been for cartons where serial numbers are placed in a consistent, repeatable location. A more complex application in design is to serialize a round container. The challenge with round containers is that the serialized code is never in a consistent orientation or location due to the rotation of the bottle. CRB will leverage previous experience with round containers to minimize any issues and a 360-degree vision system will be required to locate and confirm the serial number.