S
singber
Hello,
Can anyone provide examples of how 21 CFR 820.75 Process Validation would apply to a medical device that is strictly software (clinical laboratory information system.) I understand the concept of process validation as it applies to a physical device (i.e. sterility), but cannot determine a scenario where process validation (where the results of a process cannot be fully verified by subsequent inspection and test) would apply to the manufacturing of software.
Any input would be appreciated.
Can anyone provide examples of how 21 CFR 820.75 Process Validation would apply to a medical device that is strictly software (clinical laboratory information system.) I understand the concept of process validation as it applies to a physical device (i.e. sterility), but cannot determine a scenario where process validation (where the results of a process cannot be fully verified by subsequent inspection and test) would apply to the manufacturing of software.
Any input would be appreciated.