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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.

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WARUM HCM

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Telefon: +49 228 387290-60
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E-Mail: info@hcmconsult.com

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