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Computer system validation (CSV) is often referred to as software validation. Regulated companies perform validation projects to prove that their software or system is performing as it is supposed to and is not performing as it is not intended to.
There are several examples of why software verification is important. Check out our library of warning letters to see over 200 reasons to validate your software or systems Students in our Computer Systems Validation Boot Camp read a case study about the Therac-25, a radiation therapy machine from the 1980s. Due to programming problems, the machine can administer the wrong amount of radiation to patients (often as a massive overdose), leading to serious injury and even death. If there were software validation standards, these types of instances could be identified and remedied before treating patients.
Validation of computer systems is serious and not taken lightly by the FDA and other regulatory agencies.
“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
