Supporting a Serialization and Traceability Program for a Biotechnology Company
In this serialization and traceability program case study, Clarkston Consulting partnered with a biotech company to implement TraceLink. Read a synopsis of the project below or download the full case study.
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The client is an American-based, global biotechnology company committed to helping address serious infectious diseases through the discovery, development, and delivery of innovative vaccines to patients around the world.
The client engaged Clarkston to provide serialization expertise as they transition their serialized supply chain from an Emergency Use vaccine launch to commercial product distribution in the U.S. and across the rest of the world. The critical elements to a long-term successful serialization program begin with the strategy and the selection process of the serialization software, CMO/CPO, and 3PL. To this end, Clarkston assisted in site visits to assess each Partner’s serialization capabilities, developed the applicable RFP for system, CMO/CPO and 3PL selection, and supported the final evaluation and incorporated the final decision into an overall implementation plan.
Clarkston helped the client implement their traceability system (i.e., TraceLink), collect and optimize the applicable product master data, and develop, test, and implement a world-class serialization process with their global manufacturing, packaging, and distribution partners. With the serialization process capability ready, Clarkston shifted focus to product readiness. The Clarkston team worked alongside the Supply Chain team as well as Manufacturing, Product Commercialization, Regulatory, Quality, and IT to harmonize on the serialization master data and align on artwork requirements. To finalize the client’s operational readiness, Clarkston supported the development of process maps, business processes guides, and Standard Operating Procedures. After robust system and connectivity testing, training was conducted, and alert monitoring was activated.
Download the Serialization and Traceability Program Case Study, and learn more about our Serialization and Traceability Consulting Services by contacting us below.
Contributions by Lance Parker
