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Global Governance and Support for Serialization

“We’ll cross that bridge when we get there.”

This is the typical approach most of us take on post-production matters until we get close to our serialization go-live.  Sometimes we don’t feel we have the bandwidth to wrestle with these topics while we’re in the trenches defining and implementing a serialization solution.  However, at go-live, every serialization solution needs post-production support and decision-making bodies in place to regulate the integrity of the product as it moves through the enterprise’s supply chain. Post-production support has two distinct roles.

First, they need to handle the day-to-day monitoring of the live production system, resolving transactional issues efficiently and effectively.  They also need to define, manage and implement future serialization requirements to keep the organization in compliance with new regulations. Although this might seem rather straight forward, it can often get complicated.  Organizations that operate in multiple regions with their own systems, experience more complex support structures as product moves within the affiliates and across regions.  These situations require a greater need for master data harmonization so that each of the regions and affiliates speak a common language. Ultimately, the architecture that is deployed – centralized versus distributed – helps determine the appropriate support structure for our serialization solution.

Although these matters typically don’t surface until the end of the project, I strongly recommend that a task force be assembled at the start of the project.  The task force should be responsible for defining, developing and implementing a global support structure, with associated policies and procedures, prior to the implementation of the serialization and traceability solution. As the old expression goes, “Pay now or pay later, but pay you will.”  Unfortunately, when it comes to preparing for post production support, paying later is much more costly on many fronts.

Tags: Serialization & Traceability