This message was posted by a user wishing to remain anonymous
Hi RAPS,
Instead of following a hierarchical model for requirements (User Reqs > System SW Reqs > Unit SW Reqs), is it possible to use a flat Software Reqs document? My company wants to use this method as our JIRA to QMS setup does not allow for more than 2 levels of traceability.
As an example, if A, B, C, and D are software reqs for a software with two units -
1. Unit Level Verification - A&B are verified (one unit), C&D are verified (second unit)
2. Integration Verification - A&B + C&D is verified
3. System Level Verification - ABCD is verified (a software run is verified)
While I'm not a fan of this approach, I have been through 62304 and the FDA validation guidance a couple of times and can't find anything that goes for or against. Will it simply be a case of being able to provide a strong justification on why this verification approach works (I'm aware the QMS limitation won't be a strong justification and am trying to convey that)?
Any help, pointers, recommendations are appreciated!