MATT
CONSULTING
SERVICES
COMPUTERIZED SYSTEM VALIDATION
The FDA and other regulatory bodies require validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems.
As soon as IT project in the GxP environment is shaped and a project purpose is formulated a CSV expert must be consulted to ensure appropriate measures. I will help you to define those measures and, together with YOU, allign them with all activites throughout the project.
REQUIREMENT ENGINEERING
A requirement defines one, and one only, behavior that is needed or wanted by the business in order to achieve its goals.
In my opinion, requirements are one of the most under-rated aspect of most projects. A requirement is nothing more than an expected outcome of the project. I will sit together with YOUR user and all necessary stakeholder. With this team we develope the requirements according to the SMART method.
PROJECT MANAGEMENT
Professional project management is crucial for the successul execution of IT projects and hence ultimately for the success of every business.
Managing GxP-relevant projects competently and intelligently is my passion. I combine deep compliance expertise with project and change management and ensure the primary goal of project management in YOUR GxP-relevant IT projects: structure and consistency.
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