Multimedia Medical Systems 3/18/97 Therapac-Plus and Compute-Rx-Plan Software
2. Failure to have approved, dated, and signed Device Master Records for Therpac-Plus Software and related Standard Operating Procedures (SOP) 100 through 133 [21 CFR 820.181].
3. Failure to establish written procedures for the manufacturing and processing of the finished device [21 CFR 820.160]. There is no written procedure and documentation to show that the functionality test had been performed for Therpac-Plus Software Versions V6.409106, V6.409166, V6.409266, V6.411226, V6.411196 and V6.401247, prior to release.