Validation of Computerized Systems (GxP)

MAIN OBJECTIVE

To perform effectively and efficiently the documented process of assuring that a computerized 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 computerized system validation in the field of G(x)P and to ensure in parallel the effectiveness and efficiency of the process: Doing the right things in the right way.

OUR EXPERTISE

We are a competent team of experts with profound knowledge and long-term experience in computerized system validation for G(x)P purposes.
We ensure a state-of-the-art process for validation of computerized systems based on regulatory guidelines bridging all documentation requirements and business needs.
We know what is needed and what is unnecessary.

YOUR BENEFIT

You have the experts on board needed to design and execute the process of computerized system validation for G(x)P purposes.
Compliance with regulatory requirements and audit-readiness.
If you know what you have to do, you can save a lot of time, money, and effort because you are doing the right things.

UNSERE REFERENZEN