ARTICLES BY DAVID COLOMBO

  • Pills bar code
    Serialization Data – Who Needs It And Why?
    11/18/2016

    As pharmaceutical manufacturers continue to implement serialization capabilities, there is often a failure to recognize key stakeholders within the organization who will require access to serial number data. For some organizational roles, access to serialization data will be needed on a routine basis to perform on-going activities, while for other roles the need may be required as part of an unplanned event, such as a recall, product complaint, or inquiry. To date, the majority of attention for defining requirements and qualifying solutions has resided with the serialization program/project team and has been concentrated on the data exchange between manufacturer and contract manufacturer enterprise systems and between enterprise systems and packaging site/line systems.

David-Colombo-KPMG

David Colombo

David Colombo is a director within KPMG’s Life Sciences Advisory Practice, with over 25 years of experience supporting supply chain execution processes at a large global pharmaceutical company. Prior to joining KPMG, he spent six years dedicated to product coding, serialization, and traceability implementing solutions in Turkey, China, South Korea, the EU, and the U.S. You can reach him at davidcolombo@kpmg.com or connect with him via LinkedIn.