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26 Jun 2017

Technology selection identified as biggest hurdle in serialization race for compliance

Resourcing the deployment of serialization systems and processes also cited as a significant barrier to compliance with European FMD,

New industry research explores the greatest barriers to serialization success as companies across the pharmaceutical supply chain prepare for new regulations in the US and Europe.

The research, conducted by serialization system provider SEA Vision and life science technology specialist Zenith Technologies, highlights technology selection as the biggest challenge currently faced by the industry, cited by 28% of respondents.

As the industry considers the implications of the European Falsified Medicines Directive (FMD), one quarter of respondents rated understanding global serialization requirements as the biggest challenge they face. Fourteen percent are most concerned by the tight deployment timescales, while 12% believe that resourcing the deployment of serialization systems and processes is the biggest barrier to compliance.

Other cited challenges include establishing lifecycle support for their systems (7%) and selecting an implementation partner (7%).

Commenting on the research, Carlos Machado, serialization director at SEA Vision US, said: “Preparing for serialization is a complex task and it is clear that the challenges that companies must overcome are wide ranging.

“Technology selection and implementation is key to project success, and flexibility and scalability are important factors to consider when selecting a serialization solution that is built for the future. Given the multiple technical and logistical challenges associated with implementing a solution, reputable providers should be able to demonstrate a concrete track record of working across varying global serialization architectures. We expect to see a growing reliance on third party support providers over the coming months as many pharmaceutical manufacturers lack the internal resource and expertise to face the challenge of serialization head on.”

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.

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