Pharma Manufacturer went beyond Track and Trace compliance by combining serialization and aggregation

 

 

Customer Profile

 

A pharmaceutical manufacturer with more than 4 decades of history that has a complete production program of finished drug forms for countries in the CEE region.

The company is constantly developing its portfolio and cooperate with other companies to develop high-quality new products for pharmaceutical use.

The modern facility, located in Europe, reaches its high-volume production goals by introducing high levels of process automation on a plant level involving innovative software technologies and the most advanced equipment available.

 

Challenges

 

The company had to comply with the serialization regulations (i.e. the EU FMD in Europe). Additionally, the company had a short-term plan
for its business expansion in the Russian market, so the aggregation was also in the spotlight.

The company’s one of highest priorities was to implement into the production high-quality software and hardware, meanwhile, supporting the sustainability of businesses within the CEE
region.

The company had considered SoftGroup as their trusted partner who could help the company assess current and future laws as well as provide expertise on how to comply. It is worth noting
that the customer was very forward-thinking in its process: the company’s lines were serialized and aggregated at the same time, even though it was not mandatory to implement aggregation
yet at the current market. The customer’s team had anticipated and planned for the aggregation requirements in Russia.

Download the case study and find how the pharma manufacturer got beyond the Track and Trace Regulatory Compliance and benefited from the all-in-one traceability system of SoftGroup.

 

 

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