How Roche Benefits from Compliance?

Roche Implemented the Mass Serialization and Supply Chain Transparency Solution

Hoffmann-La Roche Ltd, the global pharmaceuticals manufacturer based in Basel, is the third largest pharmaceuticals business in the world. As long ago as 2009, Roche began work on defining a comprehensive strategy to introduce mass serialization and traceability – all along the supply chain – for its medicines and medical products. The aim was not to implement serialization as a mere add-on to existing processes, but to use the need to fulfil statutory requirements as an opportunity to completely rethink certain processes. This highlighted areas with room for improvement and revealed scope for maximizing the potential benefit for both patients and the business.

After a year spent developing its strategy, Roche started on the first implementation phase, which involved a total of six sites in six different countries across three continents with around 50 (sometimes very different) production lines. The typical line structure consists of one to three machine cells, which means the Track & Trace solution involves around 100 machine cells in total.

The role of Laetus is to supply the Track & Trace software and implement it within the existing IT landscape, as well as supplying the six OEMs concerned with the hardware components required for implementation of the Roche program. The applications and systems engineers at Laetus are working closely with the relevant OEMs to integrate the components into the machine cells. The validation phase has been greatly accelerated thanks to comprehensive pre-validation work performed at a test center specifically set up for this purpose.

The “Center of Excellence” facilitates testing and validation of new software versions prior to any roll-out on the actual production line. It also supports training under real conditions, with no need to disrupt the live production process.

Keys to Success

1. Detailed definition of strategy early on
2. Fixed project team of experts
3. Early involvement and close collaboration with OEMs
4. Standardization of processes for a secure supply chain

A vision becomes reality

Roche saw the necessary implementation of the various national serialization regulations as an opportunity to set the course for securing the supply chain. To achieve these long-term goals, the responsible project team developed a strategy for step-by-step implementation. Together with Laetus, Roche has created a solution that not only complies with different national regulations, but also lays the foundation for increasing customer benefit and thus its own business value in the long term.

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