Who We Are?

We’re
quality management experts.

© gorodenkoff – iStockphoto.com

About Us.

Curious About Our Culture?

Since 1998, we have been working in the GxP-regulated pharmaceutical industry, building on automation and EPC experience in the chemical and petrochemical industries since 1991.
Since 2020, we have been shaping the regulatory-compliant implementation of MTP-based Plug & Produce approaches for modular plants and systems.

managing director.

Thomas makait.

In the pharmaceutical industry since 1998;
in industrial automation since 1991.
Lead of the Global ISPE® GAMP® SIG „MTP in Pharma”.
Active in BioPhorum®, GAMP®, GAMP® D-A-CH, ISPE®, NAMUR, PROFIBUS, VDI.

more on ISPE®.
more on LinkedIn.
innovation, research and development.

simon makait.

University of Applied Sciences
B.Eng. Electrical Engineering and Information Technology.

Apprenticeship
Electronics technician in automation.

more.
Committees.

Forward Thinking communities & expert groups.

Provide external expert support to the current Plug & Play Working Group during the update of the Plug & Play Computerised Systems Validation Strategy, originally published in 2021.

Initiation and management of the Global ISPE® GAMP® Special Interest Group (SIG) “MTP in Pharma – Modular Plant Validation and Qualification”.
See Communities of Practice – GAMP® Module Type Package Special Interest Group:
Thomas Makait | ISPE | International Society for Pharmaceutical Engineering

Provided external expert support to the joint NAMUR working groups 2.4.1 “Process Orchestration” and 2.3.1 “Batch Control” in the preparation of NE 185 “Requirements for the qualification of the process control technology (PCT) of modular plants in the GMP environment”, published in 2022.

As a PNO member, we provide expert support for the current update from MTP 1.0 to MTP 2.0.

Active member and contributor to the VDI/VDE Automation Methods Committee since 2005.

Provision of training courses for the professional preparation of requirements specifications and documents for automated manufacturing systems:
Lasten- und Pflichtenhefte für Automatisierungssysteme erstellen

expertise.

Don’t Be Shy, ask us.​

Get in touch with us.
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