Discover your next big idea for life sciences at PACK EXPO Las Vegas
Experience a breakthrough in life sciences packaging—explore solutions from 2,300 suppliers spanning all industries, all in one place this September

EU FMD Compliance: CMO Adopts Network-Tenant Approach

In one month, partners delivered a fully validated Level 3 solution and six packaging lines with full aggregation.

EU FMD Compliance: CMO Adopts Network-Tenant Approach
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.

Break out of the ordinary: see what’s new in life sciences packaging
<strong>At PACK EXPO Las Vegas, you’ll see machinery in action and new tech from 2,300 suppliers, collaborate with experts and explore transformative solutions. Join us in September to experience a breakthrough for life sciences products.</strong>
REGISTER NOW & SAVE!
Break out of the ordinary: see what’s new in life sciences packaging
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
Read More
FDA warning letters surge - is your team prepared?