The validation process for metrology software

Validation of metrology software is required for all quality systems. It is both beneficial and economical to validate software programs before implementation. Using the Fluke MET/BASE version 5.1 software, as an example of the validation process, this paper will explain the process used at Siemens Medical Systems. It will include the process of validation for new software and the updating from previous version software. This process is the establishment of the software requirements, development of validation tests, execution of these tests, the approval process and what happens if software fails to pass any tests.