IT-Infrastructure on the Way to 4.0 - Prerequisites for GMP Compliance

In the course of ongoing digitalization in the pharmaceutical industries, regulated companies are facing new tasks regarding GMP compliance. Topics such as user administration, data integrity, data security and data archiving, network-compatible end devices, possible connections to the Active Directory, LDAB and OPC interfaces, and even basic requirements for the organization itself are coming into focus.

These are the topics addressed in the technical presentation

IT-Infrastructure on the Way to 4.0 - Prerequisites for GMP Compliance
which Dr. Georg Schwarz, Principal Consultant of gempex GmbH, presents at the Lounges in Karlsruhe on 18.04.2023, 11: am room 8. 

Key points are:

  • Infrastructure for production and laboratory environment
  • Data integrity
  • Basic infrastructure for 4.0
  • Prerequisites for devices and organization
  • Simplified IT validation approach

The advantages and disadvantages of a GMP-compliant, digital centralization of all systems in a pharmaceutical plant are described. The effort required for conversion is considered and compared with the simplified validation approach in a centralized environment.

On the other hand, fundamental structures of central data management in the regulated environment will be discussed. What basic infrastructure needs to be created for 4.0?  What must be considered and what are the requirements for conformity that end devices must bring along?

Using simple examples from the pharmaceutical sector, a central digital setup in the production or laboratory environment is presented. In addition to advantages or technical requirements, the necessary knowlege within the organization will be discussed. IT know-how in the automation or laboratory environment is indispensable here and may have to be built up from scratch.

Interested parties are invited to dive deeper into the topic of "IT infrastructure – GMP Compliance" in a personal discussion with the gempex IT experts at booth D12.

The gempex expert team is also available to discuss this topic via


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