Research reveals costly implementation is the biggest barrier to serialization compliance

The time it takes to develop a solution has been gravely underestimated by a large part of the industry.

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 US and Europe.

A further 33% of survey respondents stated the implementation process would be a drain on internal resource. Others (31%) 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.

Commenting on the research, Carlos Machado, serialization director at SEA Vision US said: “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.

“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.

Machado continued: “With time and cost becoming a growing concern across the pharmaceutical industry, it’s no surprise that smaller partners, particularly contract manufacturers, are looking to consolidate to expand their internal resource.

“In addition to consolidation and a growing trend to outsource serialization requirements, it is also likely that we will see an increased reliance on third party implementation specialists with the knowledge and expertise to effectively introduce the necessary changes and also help companies realise the wider business benefits that can be achieved. For example, implementing serialization can also help to improve line performance and overall equipment effectiveness (OEE).”

In 2016, SEA Vision and Zenith Technologies formed a global partnership to support pharmaceutical companies with the impending challenge of installing and integrating serialization across drug manufacturing sites.

The collaboration brings together Italian-based SEA Vision’s serialization system along with global Zenith Technologies’ ability to integrate systems and deliver ongoing technical support at a local level.