Computer Software Validation (CSV)
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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.