Implementation costs the biggest barrier to serialisation compliance, notes research

Recent research from serialisation software provider, SEA Vision, and life sciences technology firm, Zenith Technologies, has revealed that for the majority of industry professionals the cost of implementing serialisation is the biggest barrier to compliance.

It is the investment required for implementation of a serialisation solution that is causing most concern before the regulatory deadlines in the US and Europe, however, 33% of respondents also specified that the implementation process would drain internal resources. Other respondents (31%) stated the tight timescales as worrying.

“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,” commented Carlos Machado, serialisation director at SEA Vision US. “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 serialisation could have at an operational level.

“Consolidation across the outsourcing space has been prevalent for some time now and serialisation 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 serialisation, 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 serialisation 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 serialisation can also help to improve line performance and overall equipment effectiveness (OEE).”