Case Study

Implementing drug serialization and aggregation: A CMO’s case study

Implementing drug serialization and aggregation: A CMO’s case study

Pages 4 Pages

SERIALIZATION AGGREGATION TRACEABILITY Implementing drug serialization and aggregation: A CMO’s case study This case study examines a CMO’s multi-sites, multi-lines implementation of a serialization and aggregation software solution to address regulatory requirements from China, South Korea, Brazil and the USA. CASE STUDYAction Plan In order to adapt to the existing installation and prepare for future implementation and upgrades, the Adents Pharma Suite was selected and deployed at 4 different sites on 7 lines. It included: • For each site: A centralized configuration and process software at site level (Adents Pharma Supervisor) enabling interface with ERP and EPCIS systems, multi-line configuration and serialization parameters management for country-specific requiremen

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