MePIS Gencode
Serialization and Aggregation

Easily meet anti-counterfeiting and Track & Trace technical and regulatory requirements

L3 & L4 MePIS GenCode software and L0-L2 software and hardware components, which are powered by Inel. It seamlessly integrates into the existing IT environment and with MAH/CMO.

MePIS GenCode is a battle-proven solution that meets all regulatory requirements (e.g. CFR Part 11, EU Annex 11) and has delivered proven value in the production of companies in numerous countries (e.g. European Union, Russia, Ukraine). It can be provided as a turnkey solution that includes everything from integration to packaging lines and reporting to hubs. We can also provide complete validation life cycle documentation and consulting support.

MePIS GenCode is an excellent Track & Trace solution for combating counterfeit medicine and other products.

Features:

Main MePIS Gencode features:
  • “One-stop-shop” for Serialization and Aggregation (L0-L4)
  • Central Repository (Level 4): CMO/MAH Interfaces, Regional Hubs
  • Plant Server (Level 3): MES/ERP Interfaces, P&V Interfaces
  • Print and Verify (Level 0-2) powered by Inel
  • GAMP 5, FDA 21 CFR Part 11, EU Annex 11 and GMP compliance
  • Electronic signatures
  • Audit trail
  • Complete validation Life Cycle documentation and consulting support
  • Predefined test procedures
  • Ready for validation
mepis gencode_screenshot

Benefits

Key MePIS Gencode benefits:
  • Meet regulatory requirements more easily with a productized yet modular and flexible system (different combinations possible: L0-L3, L3-L4, L3, etc.)
  • Benefit from a reliable and efficient system with a proven track record
  • Simplify serialization and aggregation projects with a turnkey solution that covers everything from integration to packaging lines and reporting to hubs
  • Assure complete validation Life Cycle documentation and consulting support
  • Ensure seamless integration into the existing IT environment and with MAH/CMO

References

Alkaloid, AptaMedica, BCPP, Belupo, Bosnalijek, Farmak,
Galichpharm, Genericon Pharma, G.L. Pharma, JGL, Krka,
Lek (Novartis), Marifarm, Montavit, SMED, Stada, TAD Pharma