Computer Software Validation (CSV)

Our team of experts have experience in the full lifecycle of CSV

"Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled." General Principles of Software Validation: Final Guidance for Industry and FDA Staff.

General Concept

i3InfoTek has domain expertise in end-to-end CSV that is required by FDA and other global governing bodies.
Our team of experts has experience in the full lifecycle of CSV, as depicted in this diagram:

How We Can Help

Quality Planning

A software life cycle model and associated activities should be identified, as well as those tasks necessary for each software life cycle activity.


Requirements development includes the identification, analysis, and documentation of information about the device and its intended use.


The completed software design specification constrains the programmer/coder to stay within the intent of the agreed upon requirements and design.


It is the last stage in decomposition of the software requirements where module specifications are translated into a programming language.

Testing by the Software Developer

It is a time consuming, difficult, and imperfect activity. As such, it requires early planning in order to be effective and efficient.

User Site Testing

This testing should take place at a user's site with the actual hardware and software that will be part of the installed system configuration.

Maintenance and Software Changes

Failure to archive this information for later use can significantly increase the level of effort and expense of revalidating the software after a change is made.