Computer System Validation: Avoid trouble with the FDA and the auditor

Validation of computer systems is required by law and is checked during FDA inspections and QM audits. We will help you to validate your computer systems promptly and with minimal effort and thus to pass your inspection and audit without stress.

What we can do for you

In just a few days, our experienced IT and regulatory affairs experts will help you to perform a documented validation of your computer systems to comply with the requirements of FDA and ISO 13485. If you wish, we will support you in these steps:

  • Identify systems
    We help you identify the computer systems that you need as a prerequisite for validation so that you avoid unnecessary work.
  • Determine the scope of the validation
    In the next step, we work with you to determine the minimum scope of the "Computer System Validation" for each system in order to minimize time and costs. A validation is often sufficient, but sometimes the FDA requires documentation of the development process (it uses the term "validation" a little more broadly).
  • Formulate system requirements
    We then support you in specifying and documenting the requirements for your systems. We will take care of this for you if you are under time pressure or have resource bottlenecks. This makes things easier for you.
  • Test systems
    Depending on the results of Steps 2 and 3, we will create a validation plan with you or for you and perform the validation. This gives you assurance that the systems are working as specified.
  • Compile documentation for the FDA/auditors
    With regard to the form of documentation, the requirements of the FDA and ISO 13485 differ somewhat. We will show you how you can create not only legally compliant, but also lean and "maintainable" documentation. This saves you work in both the short and long term and ensures that FDA inspectors and QM auditors wave through your "Computer System Validation" without a hitch. 

Why it makes sense to let us help you

With our support you will obtain computer system validation

  • Very quickly (often in just a few days):
    We are specialized in this and have performed it countless times. In this way, you can release your systems promptly and thus develop or produce, for example, in accordance with the law, and generate revenue more quickly, without wasting time.
  • Produce it at minimum cost:
    Because we can work so quickly and enable you to take on as much as possible yourself, there are no high costs. This makes you permanently independent of advisers (us included), and you save money.
  • In a lean and legally compliant form:
    Our experts are also auditors and know exactly what matters. They ensure that you avoid time-consuming and costly repairs, and this way you get the systems validated quickly before the auditor or inspector arrives onsite.
  • Create documentation with no risk of any kind:
    Because we have already validated and documented a large number of systems, it is easy for us to precisely estimate the effort and costs in a short time and to agree with you. This gives you total planning security. We also give you a 100% satisfaction guarantee. If you are not completely satisfied, you won't pay a dime.

How we can help you

We look at your situation and any existing documents and within two days we will tell you exactly what you need to do to complete your computer system validation in accordance with the law. We will then support you, for example

With answers via email or telephone. We often do so free of charge (more information).. By validating your IT systems on-site, by ourselves or together with you. Or, if necessary, with templates that contain explanations and which you "only" have to fill out.


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