Had there been software validation standards in place, these types of instances could have been identified and remediated prior to the treatment of patients.Ĭomputer system validation is serious and the FDA and other regulatory agencies do not take this lightly. Due to programming issues, the machine could administer the wrong amount of radiation to patients (often as a huge overdose), which led to serious injuries and even death. Our Computer System Validation Boot Camp students read a case study about Therac-25, a radiation therapy machine from the 1980s. Look at our library of Warning Letters to see more than 200 reasons to validate your software or systems. There are several of examples as to why software validation is important. Regulated companies perform validation projects to prove that their software or system is performing the way it is supposed to work, and not performing in ways that it isn’t intended to work. What is Computer System Validation and How Do You Do It? By Rodrigo Perez, 11th April 2018Ĭomputer System Validation (CSV) is often referred to as software validation.
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