In the regulated industries, numerous laws, conventions and guidelines (GxP, GDP, cGMP, 21 CFR, ISO 13485, FMD, MDR etc.) require the validation of computerized systems such as ERP systems as well as the underlying IT infrastructure qualification.
Computer system validation (CSV) serves as documented evidence of the functionality of a system for a guarantee of product quality, patient safety and data integrity (GxP compliance).
Change management processes ensure continual maintenance of the valid and qualified system status. It is an essential component of the company’s quality assurance.