Arend Jan Wassink

Capgemini Nederland BV
Lead Manufacturing & Process Engineer in Digital Manufacturing and Validation
Arend Jan Wassink is an Senior Expert Quality and Validation at Capgemini Engineering based in The Netherlands focusing on OT, Automation and IIoT. He has a bachelor degree in Business Informatics and has over 30 year experience in various IT roles and is 20 years active in the pharmaceutical industry. He joined the ISPE PHARMA 4.0 Community of Practice in 2019 and is co-chair of the Process Data Mapping and Critical Thinking subcommittee.

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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...