You’ll likely find serialization ranked near the top of the ‘Most annoying/frustrating/irritating/just plain bad things to ask a Pharmaceutical Supply Chain executive’ list these days. As is often true, being told you have to do something, rather than deciding to do it on your own, typically has negative connotations associated. Not helping the cause are the occurrence of multiple delays to US state level regulations and an overall sense of confusion that still exists in the industry- when will federal laws be defined, how do I meet the growing number of regulations around the world, who/what/when/where is needed to take on serialization at my company.My goal with this blog is to provide some insights on how to envision the end state of serialization at your company, realizing it’s a journey, and most importantly what missteps should be avoided early in the process.
While it’s unfortunate serialization has become a ‘dirty little word’ what’s more concerning are the initiatives that many companies have taken on to do ‘just what is needed’ to meet regulatory compliance- and not view serialization from a much broader perspective. The narrow focus often means that process impacts are largely under-estimated and IT integration are siloed- all topics of an upcoming blog entry.
But more impactful is the vicious cycle this creates between the industry and its serialization solution providers. The minimalist approach of companies hasn’t pushed the majority of vendors to innovate. As a consultant I’ve seen platforms that have gone largely unchanged in 4+ years- but in a sense can you blame the vendor? Partially yes, but their customers were never driving them to expand and enhance their offerings. The vicious cycle comes full circle then as pharma companies are stuck searching, confused as to where the mythical ROI, that everyone demands, will come from.
This trend (I say biasedly) is coming to an end as a crop of new vendors enter this space and push competition. My hope is that companies expand their view of serialization, from the start, as not just bar coding unique identifiers on products to meet regulations, but as the enterprise wide, cross- discipline program it invariably becomes.