b. Changes made to the software program for the _____ have not been formally reviewed and approved by designated representatives of the firm…..Your response is not adequate because it does not include documentation showing formal review and approval of the software program changes.

a. A user manual (or SOP) is not available for the _____ computer software that controls the _____ system.

b. There are no written, reviewed and approved, specifications for the software program for the _____ system.

The response is not adequate because no documentation was provided showing approved specifications for the software program for the _____ system.