Data attributes and reporting requirements differ between markets. National system requirements, with short deadlines, can appear from nowhere.
Mark Davison , an EU based serialization expert for rfxcel, discusses the importance of an implementation plan in serialization and full support from track and trace vendors learn more rfxcel Implementation Serialization Plan.
Mark has been in the biotech and Pharma industry for more than 10 years and has witnessed the legal changes in the external environment regarding serialization, track and trace and pharmaceutical supply chain regulations.
The industry evolved from 10 years ago where there were multiple different suggestions, different legal initiatives and different philosophies of how to trace product through the e-pedigree years. Companies theorized 50 plus solutions to providing a safer supply chain. Currently, there are industry standards that guide the Pharmaceutical industry in regards to implementation and serialization, track and trace systems.
The tools and products have evolved to become compatible across different markets that have implemented these standards. Nevertheless, there are still significant geographical requirements, variations, deadlines, and changes that affect how a company does business. It is important to choose a solution provider that understands these standards and can integrate your supply chain to the appropriate markets. Companies should ask about the implementation plan in serialization and show documentation on the process.
