Case Study

Industry 4.0 for a global pharma company

ABSTRACT
We have supported a well-known pharmaceutical company in the evolution of its production processes, standardizing them at global level.

Where: United States
Challenge
The challenge of the company was to conduct an optimal quality management, in full compliance with regulations and with the aim of not incurring additional costs for the company and its patients.
Approach
The pharmaceutical sector is one of the most regulated ones, characterized by very strict quality standards and process controls, to guarantee the constant safety of patients. In connection with this, we have provided our support to a multinational pharmaceutical company, working in over 100 countries and specialized in rare diseases, such as hemophilia and primary immunodeficiency and in very delicate fields such as oncology and neuroscience.
Solution

To support the pharmaceutical company's Digital Transformation process, we designed and implemented a customized MES (Manufacturing Execution System) for batch management, based on Siemens eBR SIMATIC IT software. In addition to the implementation of the system, we have:

  • provided technical advice before, during and after its activation, both in the United States and in Europe
  • allowed the validation of the system according to GAMP standards
  • trained and supported the end users
  • provided remote administration, maintenance and support for the MES system.
Results
Markets
Ecosystem

Impacts

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