MATT
CONSULTING
ABOUT ME
MY APPROACH
Methodical, process-oriented and risk-based validation approach
I analyze the relevant GxP requirements for you and pragmatically specify the measures you will need to take based on risk analyses. With expertise in project and process management I set up the process and plan it together with you according to your needs.
- METHODICAL
- PROCESS-ORIENTATED
- RISK-BASED
- OUTPUT-DRIVEN
- COST-BENEFIT RATIO
Paul-Stephen Matt
QUALITY &
CSV SPECIALIST
German native with a passion for Scrutiny and Diligence. I am mobile, hard working and my whole career is turning around IT quality and computerized system validation all over the world.
I base this approach on the V-model from the latest version of GAMP, the ISO standards and FDA requirements (in particular 21 CFR Part 11) and the European authorities (in particular EU GMP Guide Annex 11). My approach is tailored to the needs of our customers and meets all the criteria for an optimal costs&benefit ratio.
THE PROCESS -
PROJECT PHASES
INITIATE & DEFINE
Define the framework, approach for your project and assess the initial risk
DESIGN, BUILD & TEST
The development team provides a framework with appropriate test data
TRANSITION
Final preoperational work is executed. The phase is finalized with the Go/No-Go approval
DEPLOY & CLOSE
The solution is deployed to the customer and final checks are performed if necessary
© 2022 Matt Validation GmbH