EU FMD Compliance: CMO Adopts Network-Tenant Approach

In meeting EU FMD requirements, many early serialization adopters have found that managing serialization, compliance and master data for products in the European market is more complex than initially thought. This challenge, explains Jean Marie Aulnette, Vice President of Sales, EMEA at TraceLink, was “compounded by businesses that chose to create point-to-point connections with supply chain partners for the exchange of data instead of adopting a network-tenant approach.”

Contract organization Rommelag CMO in Germany faced these partner connectivity challenges when the company sought to implement serialization in Europe. The company began its preparations for the EU FMD in 2017, “and planned to build point-to-point interfaces with each of its customers. Due to the high risk, costs and level of complexity associated with this approach, it became clear to the project leaders at the beginning of 2018 that it was unattainable and presented great risk,” says Aulnette.

Rommelag wanted to keep its focus on core competencies, says Rainer Fraeder, Head of Packaging Development at the company. “Validation and maintenance of point-to-point connections would be a distraction.

“To reduce complexity and eliminate costs associated with the maintenance of interfaces, we decided that managing partner connectivity and compliance reporting through a network tenant approach would be the best option for us as a CMO, hence our decision to partner with TraceLink. And, as a level 3 provider, Vimachem specialized in exactly our requirements. The quality and flexibility of Vimachem Level 3 SSM [Serialization Site Management] has decisively contributed to the success of the project.”

“Within one month, Vimachem and TraceLink were able to deliver a fully validated Level 3 solution and six packaging lines with full aggregation for Rommelag CMO,” says Alex Vidras, Vice President of Business Development, Vimachem.Vimachem reports that its full integration with TraceLink, its advanced line manager and the service team allow them to deliver validated Level 3 SSM systems in approximately three to four weeks from project kickoff.

“In their journey to serialization compliance, some businesses did not see the risk associated with point-to-point connections early enough, or at all for that matter,” says Vidras.

For companies who have missed the deadline and are not close to validating their system, partners who can provide pre-configured systems for data management and exchange offer a way to move forward.