Implementation of Traceability Matrix in Validation Life Cycle of Equipment

[v9991]

Normally traceability matrix is mandatory in software validations.
How helpful/relevant is this concept for equipment validations?
Equipment I am referring to is broadly in two categories:
1) Fabricated to customer requirements with PLC controls.
2) Pre-fabricated (kind of off the shelf) equipment with PLC-controls.

[Stijloor]

A Quick Bump!

Can someone with this expertise respond?

Thank you very much for your help!!

Stijloor.

[yodon]

I have personally used a trace matrix on equipment validation and found it quite useful. We took a traditional IQ/OQ/PQ approach and used the trace matrix to map requirements to verification tests in OQ.

I feel it's a great tool to help assess coverage, show completeness, track progress, identify and isolate regression testing, etc.