Sebastian Niederhauser

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CTS GmbH
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Sebastian Niederhauser is Branch Manager and Authorized Officer at cts GmbH in Vienna, responsible for developing projects and driving innovations such as RAMI. He holds a degree in electrical engineering and has more than 20 years of experience in the pharmaceutical industry. Sebastian’s main focus is in process automation, ranging from field instrumentation to DCS, batch, and historian systems. He is an active contributor to the Process Maps & Critical Thinking Subcommittee. He has been an ISPE member since 2018.

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Figure 1: Process-centric vs. data-centric approach.
Technical
Methodology to Define a Pharma 4.0™ Roadmap

In the context of data integrity, data flows are essential. The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. The key to data integrity compliance is a well-functioning data governance system1

  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised...