Hello. We are a contract manufacturer & make 1 'finished' medical device (not labeled, packaged, or sterilized but functional). Our company builds our own capital printing equipment & provide the service of printing. We are being asked to do a SW Validation for this equipment. It talks to our network, obtains specified AutoCAD files (generated by Engineering years ago during the process validation with the OEM) then those direct the printer what & where to print; there is 1 machine per printing step. We 100% electrically test all parts & 100% visually inspect. We have had 0 field failures in all the years we have done this. The handful of customer complaints are unrelated to this. We have validated our automated Excel spreadsheets & test software that we developed, however this has not come up before. How can we best & most easily meet the requirement? Thank you!