Established documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.

Source: GAMP 4 (FDA)

I would suggest this be re-titled as Process Validation and then add a new entry for “Design Validation.”

Per 21 CFR Part 820.30(g):

“Design Validation shall ensure that devices conform to defined user needs and intended uses and shall include testin of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate.”