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Computerized System Validation

We drive you to GxP compliance

Computer-aided systems that have an impact on product quality, patient safety and data integrity must be validated within the GxP environment (medical technology, pharmaceutical & life science sectors). The validated state must be maintained for the entirety of the system lifecycle. Ensuring a validated state can be extremely challenging for a company as the specific expertise may not be available to approach it pragmatically and efficiently. We can help you consistently and reproducibly ensure that your computer-aided systems are GxP compliant.

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Compliance with guidelines and laws during validation

One of the challenges in validating computer-aided systems is compliance with, and expertise in, the following regulations and legislation:

  • EU Directives and the quality management standard ISO 13485
  • national pharmaceutical legislation
  • American FDA (Food and Drug Administration) requirements
  • Regulations from 21 CFR Part 820, 21 CFR Part 11 and EU GMP Annex 11

Validation of systems usually takes place in accordance with GAMP®5 industrial standards.

We provide appropriate solutions

  • Consulting
    Validation, training and advice all tailored to your needs.
  • Validation as a Service
    A turnkey approach and offers based on defined project services.
  • Greenfield
    We support you in the creation, implementation and maintenance of your own framework.

Consulting, Validation as a Service or Greenfield

Streamlined, smart processes and a risk-based approach are the key to cost-effective computerized system validation. With our end-to-end solution, we can support our customers to consistently and reproducibly ensure that computer-aided systems are GxP compliant. In this case, our service is available as an ongoing service, on a project basis, or as a consulting contract.

  • Consulting

    Do you already have basic knowledge about validation of your computer-aided systems and thus only require support in specific areas? Are you lacking resources in certain areas or would you like to train your staff? We would be delighted to provide our expertise precisely where you require it.

  • Validation as a Service

    Do you not have the necessary resources for partial or complete performance of system validation? If so, then our managed service is just right for you. We handle validation on your behalf, so you can concentrate on your core business.

  • Greenfield

    Would you like to build your own CSV system landscape to be ready for all regulatory challenges? We have the skills to develop your own cost-efficient and reproducible framework. We adapt the Axians CSV Framework to your requirements and help you implement your own CSV framework. Our Axians CSV Framework is characterized by the following features:

    • Simple to understand and apply
    • Minimal training outlay with your organization as a multiplier.
    • Repeatable: After implementation, it can be applied repeatedly
    • Reproducible: The standard leads you to the result.
    • Focused: Risk mitigation is key, not the volume.
    • Our CSV framework ensures GxP compliance and audit readiness.

Computerized System Validation Factsheet

We can help you consistently and reproducibly ensure that your computer-aided systems are GxP compliant.

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Contact us now and benefit from tailor-made solutions!

Our service is available as an ongoing service, on a project basis, or as a consulting contract.

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