FDA and Software Validation

摘要

As in any field, use of computer software in submissions at FDA requires us to make sure the software used in their preparation does what it is supposed to do. The FDA does not formally validate computer software used in these submissions. We interpret validation to be a process by which the program is shown to function properly under the conditions of its intended use. The agency may require a sponsor to demonstrate the process by which the program has been validated. If necessary the results of the validation may be requested. The sponsor of the submission usually validates the computer software used in the preparation of a submission.