Who We Are?

We’re
quality management experts.

© gorodenkoff – iStockphoto.com

About Us.

Curious About Our Culture?

For over 13 years, we have been at the forefront of technology. We work closely with universities, expert groups, communities of practice and standardisation organisations to bring the latest technology to the pharmaceutical industry in a compliant and efficient way!

managing director.

Thomas makait.

+26 years of experience in the pharmaceutical industry.
Lead of the ISPE® GAMP® SIG Special Interest Group ‘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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