The Situation
Dovema is a Czech-based contract manufacturing organization with over 20 years of pharmaceutical experience. Operating across multiple EU markets, the company required a scalable serialization and aggregation framework aligned with evolving track & trace regulations. As a CMO, flexibility and interoperability were critical to maintaining service reliability across customers.
Our Approach
SoftGroup partnered with Dovema to implement a scalable serialization and aggregation framework aligned with EU FMD and multi-market regulatory requirements.
The focus was on enabling operational flexibility across different customer mandates while maintaining full compliance and uninterrupted production.
The implementation followed several key steps:
Identify the Current State
Mapped existing packaging lines, serialization readiness, and integration points across Dovema’s production environment.
Evaluated partner connectivity requirements and reporting obligations toward EU Hub and national systems.
Design the Future-State Serialization Framework
Designed a centralized Level 3–5 architecture capable of supporting multiple MAHs and varying compliance demands.
Ensured interoperability with customer systems and readiness for future regulatory expansion.
Implement and Integrate
Integrated serialization data flow from line level through enterprise management and external reporting.
Enabled real-time visibility and streamlined partner communication across supply chain stakeholders.
The Results
Dovema successfully established a scalable serialization environment capable of supporting diverse customer portfolios across multiple EU markets.
Operational continuity was maintained while onboarding new regulatory and partner requirements.
The company improved visibility across production and reporting workflows, enabling faster response to evolving compliance demands.
Serialization readiness became a structured operational capability rather than a project-based effort.
Guide the Process and Ensure Compliance Continuity
Implementing serialization in a CMO environment requires more than technical deployment.
SoftGroup supported Dovema with a structured approach that balanced flexibility, compliance, and operational stability across customer demands.
“We now have a serialization framework that allows us to respond to customer requirements without disrupting our production flow.”
