Systech gears up for ePedigree ahead of time

By Gareth Macdonald

- Last updated on GMT

Related tags Pharmacology Pharmaceutical drug

Delays to US ePedigree and serialization laws, which will now not be implemented until 2015, could provide an unexpected windfall for US software firm Systech International and its PES platform.

Traditionally, packaging serialization was a top-down process in which unique identification labeling is applied to drug packaging in sequence as the pharmaceuticals are produced.

While the simplicity of this method has obvious cost benefits for drugmakers, it does create the potential for mislabeling or missed labeling during extended production runs. In addition, the growing need to fully account for and regulate the distribution of potent pharmaceuticals in an era of large-scale counterfeiting, means that a more regimented approach to serialization labeling is required.

Systech’s Packaging Execution System (PES), which is being showcased at Pack Expo 2008 in Chicago next week, enables bidirectional data flow between IT systems and packaging machines, creating according to the New Jersey-headquartered company, a setup that is precisely suited to rigors of industrial serialization.

The firm hopes that the data feedback provided by its software will enable drugmakers to take stricter control of individual drug products at all stages of the production process from machine to plant level.

A company representative told in-PharmaTechnologist.com that: “Serialization applications require that data is not simply pushed down from the enterprise layer to packaging systems but that intelligent information returns to the enterprise layer…for use throughout the supply chain.​”

He explained that PES “enables manufacturers to protect data integrity, maintain real-time throughput for packaging operations,”​ adding that drugmakers should seek solutions that address current needs and provide the database connectivity needed to build out their serialization requirements in the future.

These thoughts were in keeping with comments released by company COO Joe Ringwood. He explained that: “Today’s business drivers demand pharmaceutical manufacturers rethink their traditional architectures​,” adding that PES had been developed to meet this need.

Related topics Drug Delivery QA/QC

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