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The US FDA definition of validation in its guidance documentation titled General Principles of Validation when applied to a computer system reads as:
Establishing documented evidence which provides a high degree of assurance that a specific computer system will consistently produce a product meeting its predetermined specifications and quality attributes.
Computer Systems Validation (CSV) is a discipline that helps FDA regulated industries, primarily pharmaceutical, biotechnology and medical device manufacturers, ensure that the computer systems are suitable for their intended use. Specific requirements related to computers can be found in Section 211.68 of the US current Good Manufacturing Practices (cGMP) regulations.
CSV covers not only the application software and enforcement of appropriate controls and procedures throughout the Software Development Life Cycle (SDLC) of that software, but also covers the hardware used to run the application software as also any equipment and instruments .....
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