Our consultants started by developing a serialization project plan that integrated each parties’ activities and schedules.
Since packaging validation is a key driver of overall serialization program success, we worked very closely with their manufacturing partner responsible for the packaging. This company had limited experience with the US regulatory requirements for product packaging. As a result, aspects of this serialization setup were brand new for them.
We spent time building alignment between the different workstreams – clearly identifying what needed to happen and when, as well as communicating how and why these deadlines affect other workstreams. This detailed effort ensured that we addressed risks and resolved issues quickly. The timing fit together so that the company was ready for packaging validation in advance of the commercial launch.
(Note: Companies can conduct packaging validation before or during commercial launch. However, Converge often recommends completing it beforehand to minimize the risk of delays during launch.)
Converge’s project management support throughout the process included developing and managing an integrated project plan, tracking essential elements like activities, issues, and decisions, as well as building automated workflows to provide transparency for both task and milestone deadlines.
Relationship building with a deadline is challenging, but these close partnerships eliminated the need for rework later in the process.