According to new industry research more than half (54%) of industry professionals believe that the cost of implementing serialization is the greatest hurdle to compliance.
The research, conducted by serialization software provider, SEA Vision and life sciences technology firm, Zenith Technologies, highlighted that the substantial investment required to implement a serialization solution is cause for concern ahead of regulatory deadlines in the U.S. and Europe.
A further 33% of survey respondents stated the implementation process would be a drain on internal resource. Others cited tight timescales as a pain point, a statistic that is further supported by the announcement that the FDA will delay the active enforcement of the Drug Supply Chain and Security Act (DSCSA) due to a lack of readiness across the industry.
“The new regulations in the EU and the US represent a substantial upfront investment for companies across the supply chain and many smaller players are struggling to implement a suitable process as a result,” Commenting on the research, Carlos Machado, serialization director at SEA Vision US said. “The resource required in terms of cost and manpower is a notable barrier to compliance, but added to that, the time it takes to develop a solution has been gravely underestimated by a large part of the industry. Many (37%) of our survey respondents expressed concerns surrounding the potential disruption to product supply as a result of technical issues and downtime, which clearly demonstrates the impact serialization could have at an operational level.”
Consolidation across the outsourcing space has been prevalent for some time now and serialization is undoubtedly driving smaller companies to consider partnerships to offset a lack of manpower and budget. However, 36% also believed that there was a knowledge gap in their existing teams surrounding serialization, making external expertise vital to ensuring compliance.