Overview CSV (Computer System Validation) is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines for a certain industry. It is especially crucial in FDA / EU-regulated industries like biotech and pharma, since products from these sectors impact public health and safety. Why Computer System Validation? A validation assessment program is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality. The same principles are applied in computer system validation to a computer system or an information technology system. It’s essential to maintain quality standards in pharma since non-conformance can have far-reaching consequences. Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed.