Module 14 2022

Design V & V – Some common gaps

Clear trace matrix between specs & relevant reports / sections can reduce review time significantly

B. Missing protocols, reports – provide all referenced in design input/output matrix

A. Design requirements not fully verified/validated

C. Unclear organization of tests for legacy devices

D. Unclear / hidden rationales for leveraged tests

E. Evidence of performance over lifetime of device not demonstrated

F. Test acceptance criteria not met – No justifications for accepting results

G. Sample sizes, selection criteria and preparation unclear

& many more….

Many apply to packaging tests also