Approaching pharmaceutical serialization is no easy task, but technology makes it infinitely more attainable.
While pharma companies are already required to have batch-level serialization, the upcoming deadlines – February 2019 for the Falsified Medicines Directive (FMD) and November 2018 for the Drug Supply Chain Security Act (DSCSA) – require unit level serialization. These deadlines are not far away, and failure to comply can mean harsh consequences for non-compliant companies. But, with all that is at stake, some companies have still not begun the serialization process.
Pharmaceutical serialization can be made easier through specialized software. However, implementation requires a careful approach, one that assesses the parts of your business that will be affected, and an understanding of requirements in the markets in which you will operate now and in the future.
The process of serialization affects more than just the manufacturing line, before implementing any serialization solution, executive leadership must address the importance of serialization and appoint a project sponsor to work directly with the solution provider. The project sponsor’s role is to champion the serialization effort, and work with the solution provider to create and manage a schedule that clearly identifies key tasks and implementation milestones. In addition to managing a schedule, it’s imperative that risks and mitigation plans are identified and tracked throughout the process. Having a plan in place to manage risks during implementation helps to avoid common pitfalls and gives priority to the concerns of both the customer and solution provider.
Although the process of serialization may be daunting, rfxcel’s serialization and traceability solutions and approach make the process more manageable. Our 60-day implementation plan is designed to quickly on-board your organization and establish connections with your trading partners in a repeatable fashion. Our approach provides your organization with a comprehensive and scalable solution that will meet compliance regulations today and in the future.