Requirements for a company submitting medical software for approval:
(1) There is a company official in overall charge.
(2) There are policies and procedures in place for all aspects of software development.
(3) All employees are familiar with the policies and procedures, with an initial orientation and periodic education/evaluation afterwards.
(4) The development, maintenance and revision of the software is controlled with documentation.
(5) There is documentation of the software, including whenever there is an change.
(6) There is a process of testing and validating the software prior to release and periodically thereafter (see below).
(7) There is a means for a user to contact the company if there is a problem.
(8) There is a mechanism for the company to notify users of a problem and to rectify the problem.
Validation of software requires performance assessment:
(1) The software is able to handle data across all possible inputs, including data extremes.
(2) The software is able to handle incorrect, absurd or unexpected data.
(3) The software shows appropriate failure handling.
(4) The software performs an internal check to detect data or software corruption.
Testing and validation is done:
(1) before initial acceptance
(2) whenever there is a major change to the computer system
(3) periodically thereafter
