Arvato CSDB

Arvato CSDB is a serialization software solution developed by Arvato Systems, designed to help pharmaceutical companies comply with anti-counterfeiting regulations and manage the end-to-end serialization of medicinal products. The platform is used by over 80 pharmaceutical companies and supports manufacturers, contract manufacturing organizations (CMOs), marketing authorization holders, wholesalers, and distributors in meeting national and international legal requirements for drug traceability and counterfeit protection.

The solution addresses regulatory frameworks such as the EU Falsified Medicines Directive (FMD) of 2011 and Delegated Regulation (EU) 2016/161, which mandate the serialization of prescription-only medicines. Arvato CSDB handles the full serialization process chain, from production through to the end customer, incorporating Datamatrix codes, database matching with national verification systems, and tamper-evident packaging integrity checks.

Core Capabilities

• End-to-end management of the serialization process, covering production lines, partners, customers, and suppliers
• Reliable exchange of serialization data across the supply chain
• Reporting of all serialization events to meet national and international regulatory requirements
• Management of complex serialization workflow processes
• Support for aggregation and tracking requirements in addition to serialization
• Request-based provision of serial numbers to CMOs and subsequent reporting from CMOs via a dedicated network
• Track and Trace module for monitoring product movement through the supply chain

Integration and Connectivity

• Connection via standard interfaces for straightforward integration into existing IT landscapes
• Seamless integration with ERP systems and Manufacturing Execution Systems (MES)
• Flexible connection to packaging line manufacturers, with proven connectors available for well-known hardware manufacturers
• Integration with national verification systems across multiple countries
• Connectivity to systems of external service providers and CMOs

Regulatory and Geographic Coverage

• Supports compliance with both local production requirements and export requirements for affected markets
• Covers extensive reporting obligations associated with various national regulatory systems
• Arvato Systems operates National Verification Systems in 17 European countries, providing regulatory knowledge that informs ongoing updates to the CSDB solution
• Supports pharmaceutical producers, contract manufacturers, marketing authorization holders, and wholesalers across global markets

Deployment and Additional Offerings

• Available as Software as a Service (SaaS), allowing deployment in a cloud environment
• Accompanied by IT consulting and process consulting services from serialization specialists
• Can be complemented by the platbricks Healthcare Suite, an in-house development offering additional process optimization and system expansion capabilities
• Partnership with Körber Pharma noted as a relevant technology alliance

Arvato CSDB is positioned as a comprehensive serialization platform for the pharmaceutical sector, combining software functionality with regulatory expertise and consulting support to address the technical and compliance demands of drug serialization across multiple markets.