The EU FMD is putting a couple of requirements on wholesalers in Europe. In order to secure the supply chain, wholesalers are supposed to perform a risk-based verification of the products in their supply chain. Although the regulatory requirements are in place since February 2019, the usage of specialized tools is not widely spread.

Systec & Services can provide you with a full solution in a week or even less*.

* Conditions:

  • Existing server infrastructure for on premise installations (Virtual MS Server and Oracle Express DB)
  • Certificates per NMVS to be connected for integration is issued and available
  • No validation or Systec & Services validation stack (complete documentation according to GAMP5 and V-model provided by Systec & Services)

Contact Person

Dr. Martin Printz

Phone: +49 721 6634 357

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Your Challenge

Within the EU all manufacturers holding a marketing authorization have to upload master and transactional data into the national systems via the European Hub.

Wholesalers are obliged to verify and occasionally to change the status of serial numbers according to one of the specific scenarios (e.g. decommissioning + reason) against the different NMVS. With STEPLogic TRACE FMD wholesalers can submit data to all European NMVSs, at no extra cost.

STEPLogic TRACE FMD also allows wholesalers to choose  whether to work on bulk level or on item level, thus granting more flexibility.

Our Solution

Utilizing the solution created by our sister company DMLogic, who is unsurpassed in Warehouse Management
Solutions, Systec & Services is able to provide you with a full solution in a week or less.

STEPLogic TRACE FMD enables you as a wholesaler to be fully compliant with EU FMD. Even better, the high-capacity STEPLogic platform can be extended by various other functionalities, depending on your needs – including full warehouse management system capabilities.

Good to know:

  • A GMP Validation documentation stack is optionally available
  • Either cloud or on premises solution - the choice is yours