CSV Consulting

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What we offer you

We deliver a tailored approach to validating your computer systems. Our offer is individually adapted to your initial situation and your needs by

  • integrating validation into your quality management system and
  • taking into account the regulatory requirements that apply to you (21 CFR Part 11, 820 etc., EU GMP Annex 11, ISO 13485 etc.)

Our risk-based validation approach is aligned with your processes and compliance requirements. We follow the GAMP5® guidelines from ISPE as well as other international best practice approaches.

CSV Assessment

In the CSV Assessment, our experts review your validation framework, your documents and SOPs, and your experience.

The result of the assessment shows you…

  • where process improvements are needed,
  • gaps in your methodology exist,
  • methods can be simplified,
  • there is a need for training.

A CSV assessment can be performed at any time but is particularly recommended at the beginning of a new CSV project or as part of a periodic review.

CSV Framework

We work with you to build a comprehensive document framework for computer system validation, always taking into account the procedures and frameworks already in place in your organization. We draw on our CSV Library, which has been built up from years of experience and is continuously improved and expanded.

You will get

  • a complete CSV document framework,
  • the adaptation of all SOPs and templates to your company’s specifications,
  • all necessary training to implement the framework.

CSV Projects

We manage the validation tasks in your IT project to prevent surprises and delays in implementation. In close cooperation with the project management, we take over the planning and organizational responsibility of all validation tasks in the project.

  • Planning of all validation tasks in IT projects
  • Management of all CSV tasks
  • Beratung und Begleitung bei IT Lieferantenaudits
  • Managing the dependencies of different project areas to prevent delays
  • Ensuring that the correct sequence of validation activities is followed

CSV Project Management

We manage the validation tasks in your IT project so that you avoid surprises and delays in implementation. In close cooperation with the project management, we take over the planning and organizational responsibility of all validation tasks in the project.

  • Planning of all validation tasks in IT projects
  • Management of all CSV tasks
  • Managing the dependencies of different project areas to avoid delays
  • Ensuring that the correct sequence of validation activities is followed

Contact us now and request your individual consultation

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