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When a process is digitized with the help of a software, validation of the software is mandatory. This is required by ISO 13485 and also by the FDA in 21 CFR Part 820. However, there are significant differences in the concrete approach and the required effort.Therefore, it is crucial to have an appropriate software validation process established that allows flexibility for the different use scenarios.
Software used for the support of processes in quality management systems (QMS) must be validated to confirm that the software fulfills the intended purpose. Important to understand is, that the validation must be conducted on the basis of the application process and in the IT environment of the software operator.