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MAIN OBJECTIVE
To perform effectively and efficiently the documented process of assuring that a computerised system used in the context of G(x)P does exactly what it is designed to do in a consistent and reproducible manner and thereby be compliant with external and internal guidelines fulfilling regulatory requirements
MAIN CHALLENGE
Being 100% compliant in the entire process of computerised system validation in the field of G(x)P and ensuring in parallel the effectiveness and efficiency of the process: Doing the right things in the right way.
We are a competent team of experts with profound knowledge and long-term experience in computerised system validation for G(x)P purposes.
We ensure a state-of-the-art process for validation of computerised systems based on regulatory guidelines bridging all documentation requirements and business needs.
We know what is needed and what is unnecessary.
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You have the experts on board needed to design and execute the process of computerised system validation for G(x)P purposes.
Compliance with regulatory requirements and audit-readiness.