Validation

No worries about internal resources or lack of quality:
With QuACX on your side, all applicable GxP regulations are respected in your computerized system.

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Validation
of computerized systems

  • Collection and sharpening of customer requirements

  • Evaluation of national and international regulatory requirements

  • Document creation

  • Implementation

  • Test plan implementation

  • Reporting

Our validation documentation is carried out according to the V-model

CSV validations and our experience:

As a partner of the manufacturers, QuACX GmbH carries out validations of configurations in the pharmaceutical industry. With more than ten years of experience, our employees have already successfully accompanied several national as well as international audits.

Thanks to this experience, we have collected many recommendations and assistance for the correct procedure, which we would like to provide you with:

Uncomplicated service commissioning

at QuACX Distribution

Start: Kick-off date (remote or on-site)

Arrangement and follow-up

Software Administrators Training

Arrangement and follow-up

Workshop for the evaluation of the design specification

Meeting, workshop, follow-up

Creation of validation plan, URS and FRS

Parallel milestones

Traceability Matrix Document

incl. risk assessment

Implementation of created test plans

At best with own resources

Preparation of validation report

incl. deviations and incidents
Would you like to learn more?