Serialization and Track & Trace regulations are expanding across global markets. Manufacturers that export to multiple countries need a reliable system to manage serialization data, regulatory reporting, and supply chain integration. But with many solutions available, choosing the right one can be challenging.
Key factors you should consider:
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Regulatory coverage
A solution must support the countries where you operate today, and be ready for upcoming regulations in new markets. Coverage should include both established systems (such as EU EMVS for medicines or the EU Tobacco Traceability System) and fast-changing requirements (for example, US DSCSA or Brazil). -
Integration capabilities
A serialization platform should connect easily with your existing ERP, MES, and partner systems. Look for support of standards like EPCIS and APIs to ensure smooth data exchange with CMOs, 3PLs, and distributors. -
Flexibility and scalability
Regulations evolve, and business requirements change. A rigid solution may require costly custom developments, while a flexible one can adapt faster with lower effort. Consider whether the system can scale to new product groups or markets without a complete redesign. -
Operational model
Some platforms are licensed and require significant in-house resources to operate. Others, like Kvinta, can be delivered as SaaS with managed support — reducing the burden on internal IT teams. The right model depends on the size of your organization and available expertise. -
Proven track record
Check for successful implementations in scenarios similar to yours: multi-market compliance, parallel operation with existing L4 systems, or onboarding of complex partner networks.
Conclusion
There is no single “best” serialization and traceability solution. The right choice depends on your markets, supply chain setup, and operational needs. By focusing on regulatory coverage, integration, flexibility, operational model, and track record, manufacturers can select a platform — whether it is a global enterprise system or a SaaS solution such as Kvinta — that ensures long-term compliance and efficient operations.