Easily meet technical and regulatory requirements for traceability and prevention of counterfeiting of medicines and other products
Serialization and aggregation
MePIS GenCode (Serialization and Aggregation) is a complete solution for serialization and aggregation (L0-L4). It consists of the MePIS GenCode L3 & L4 software solution and the Inel L0-L2 software and hardware. It enables easy integration into an existing IT environment and connection to MAH/CMO.
MePIS GenCode is an efficient software solution that meets all regulatory requirements (e.g. CFR Part 11, EU Annex 11) and provides proven added value to pharmaceutical manufacturing in many countries (e.g. European Union, Russia, Ukraine). It is available as a turnkey solution, including everything from packaging line integration to reporting. In addition to the solution, we offer consultancy support and full validation documentation.
MePIS GenCode is the perfect Track & Trace solution to prevent the counterfeiting of medicines and other products.
Key features:
- MePIS GenCode modular serialization and aggregation solution (Track&Trace)
- Level 4 - Central code repository (unique code generation, code archive, reporting and analytics)
- Level 3 - Plant server (interfaces to P&V systems, code status management, distribution of codes across P&V systems, data integrity for levels 0 to 3)
- Complete solution with all necessary documentation, supply and commissioning of P&V systems
- Interfaces for MES/ERP
- Interfaces for EU and regional hubs
- Interfaces for CMO and MAH type companies
- GMP compliance
- Adherence to GAMP 5 recommendations
- Compliance with EU Annex 11/21 CFR PART 11
Three product packages are available for serialization and aggregation, depending on the size and needs of the production sites:
- MePIS GenCode Basic for production plants with manual packaging.
- MePIS GenCode Standard for medium-sized production facilities with a combination of manual and automatic packaging.
- MePIS GenCode Premium for large production plants with automatic packaging.
