FDA software validation

Computer System Validation has been a regulatory (e.g. FDA, Health Canada) requirement for more than two decades. Nevertheless, companies have problems with its understanding, scope, implementation and maintenance. This is proven through many FDA warning letters related to device software and computer system validation. IT professionals know the principles but..... Read More

Computer system validation (CSV) is the process of providing a high degree of assurance through documented evidence that a computer system consistently meets its pre-determined or intended use or quality attributes such as accuracy, security, reliability, and functionality. A computerized system can include hardware, software, its peripherals, interfaces, equipment, users..... Read More