Making the new healthcare regulations an opportunity in serialization

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Customer

Large multinational health care company listed among the Fortune 500. Active in three sectors, it manufactures and distributes medical devices, pharmaceutical products and consumer packaged goods.

Challenges

Our client wanted to be compliant regarding law regulation but also ensure traceability while maintaining packaging/warehousing efficiency. The main challenges were the increase of high risk repack, given tamper evidence and traceability requirements and the SKU segmentation which implied country specifics, multi-country & standard export. Consequences were needed to be taken into account such as the impact on quality and reverse logistics: sampling, return and destruction.

Solution

  •  A project management structure was designed, including governance and discipline for the entire project delivery
  • Special attention was given to change management and coherent transformation around process, organization and systems
  • Finally, a project management office dedicated to the implementation phase led the operational details & specifics, while ensuring on-budget/time delivery

Results

Practical roadmap

Traceability and its pros/cons

Articulated business case

Quality of the total delivery by appointing a dedicated PMO during the implementation

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