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Computer System Validation (CSV)

CSV and GxP Compliance: Expensive but vital?

​Validation of computerised systems according to GxP Guidelines (CSV) has been a basic requirement in the life science industry for many years. However, as the complexity in the IT landscape and the degree of automation has increased significantly, the costs for compliance have risen disproportionately over the last few years and against a background of mounting pressure to reduce healthcare costs for the long term. Validating computerised systems (CSV) is crucial to patient safety. But how much does and how much can validation cost?

The solution

Nevertheless, the outlay for validating computerised systems can be reduced significantly for both suppliers and for the life science industry, if the right strategy and an implementation that is tailored to compliance requirements and to your needs and processes are used. The HGP consultants will support you here not only as experts in GxP compliance and validation but also from the commercial aspect of cost efficiency. This is what you can achieve:

  • GMP, GLP, GCP compliant IT systems and processes
  • The security of working in compliance with FDA and EMA as well as according to current standards (21 CFR part 11, Annex 11, GAMP 5
  • Sustainable reduction in outlay and costs for the validation
  • Security for internal and external audits
  • Validation strategy for implementing the risk-based approach


We will support you to determine the location of your current validation concept by auditing your organisation, processes and tools from the following perspectives:

  • Outlay and costs
  • Satisfying regulatory requirements
  • Implementing the risk-based approach


Our consultancy package includes:

  • CSV audit: auditing the validation status
  • CSV strategy: producing and implementing a validation strategy subject to the risk-based approach (GAMP 5)
  • CSV implementation: implementing validation projects for IT systems, laboratory systems and automation systems.

CSV Audit

We audit using a standardised method, taking international requirements into account. You decide which area we should audit. For example, an audit for preparing an official inspection can therefore be carried out, (e.g. FDA) or a subject-based readiness analysis, e.g. 21CRF 11.

CSV strategy

A good CSV strategy is tailored to your processes, your organisation and IT and automation landscape. We start by identifying the current situation with the help of a standardised method, e.g. reality check (link) and will identify the organisational and technical measures particular to your requirements. In consultation with your experts we will develop a validation strategy that will satisfy the requirements of the authorities and your customers for the long term. Equally, the focus is on: the cost factor. The aims of the strategy are not only to meet requirements but equally to implement the validation tasks economically. The risk-based approach will help you to carry out future validation projects faster and with a significantly lower outlay. As an additional benefit for suppliers of machines and equipment, you are able to offer a standardised validation package that is considerably below previous costs. This service is required more and more frequently when purchasing machines and will therefore significantly increase your market opportunities.

CSV implementation

Our consultants will support your validation projects in a variety of roles, e.g. as a project manager or as a validation engineer. The experience of our CSV consultants in validating computerised systems goes back several decades and encompasses all IT, laboratory and automation systems. We know the dangers and sources of error during implementation only too well. Benefit from our expertise and avoid the mistakes made by others in the past.

Managed Validation Service

Don’t you want to worry about upcoming audits and still have full control over your CSV?

With this model, you get complete computer system validation from a single source, embedded in your organization.



Michael Clausen+45 3077 9120mccs@nnit.comAssociate Vice Presidenthttps://www.linkedin.com/in/michaelclausen1975/?originalSubdomain=dkMichael Clausen



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