Challenge
A global manufacturer needed to update labeling for four Class II pumps and roughly 500 accessories across three plants. The program connected six workstreams, SAP data, the FDA database, and replacement of aging systems at twenty-one workstations.
Response
PMO Partners established an integrated plan, brought plant teams together, and supported a common labeling approach. Sharing an existing pharmaceutical serialization concept created a more scalable solution and reduced some equipment costs by as much as 20%.
Outcome
The company reported compliance by July 31, 2016, two months ahead of its deadline. New systems supported future on-demand printing, while a detailed handoff guide and improved project practices prepared the organization for further changes. The case describes this historical program rather than current UDI requirements.
An edited client story. Outcomes and figures describe the reported engagement, rather than a promise of results for another organization.