Our client is a global pharmaceutical company that develops and produces medications and vaccines for a wide range of medical disciplines including immunology, oncology, cardiology, diabetology, endocrinology, and neurology.
Apart from packaging, serialization is one of the most important things for our client. Changes in serialization regulations affect business processes in supply chains, manufacturing, quality, inventory management, and regulatory reporting. With every CMO having various approaches and strategies to comply with these regulations, the whole initiative turns significantly more complex.
We introduced a comprehensive serialization solution that involved both business processes development and technical aspects. The approach we suggested was approved and implemented, so our engineers worked out appropriate data exchange formats, including serial number formats and the corresponding requirements. Since mapping serial numbers and serialization batch data between the company and the CMOs for reporting purposes required automated, semi-automated and manual efforts, 2 separate BPO teams were created.
of serial numbers
of auto-mapped serial numbers
dedicated team members
We tested various approaches and solutions for handling serial numbers mapping and for accommodating evolving regulations. Once standard execution approaches were developed, this initiative has been replicated across all CMOs based on various solution designs.
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