Design Verification vs Validation (V&V)

Verification answers "Did we build it right?" Validation answers "Did we build the right thing?" Both are required for design control in regulated industries.

Definitions

	Verification	Validation
Question	Does the design meet specified requirements?	Does the product meet user needs in intended use?
Reference	Design inputs / specifications	User needs / intended use scenarios
Timing	During design (at design reviews)	Final product, with real users or use simulation
Methods	Analysis, inspection, test, demonstration	Clinical trials, usability testing, field trials
Standard	ISO 9001 Clause 8.3.5	ISO 9001 Clause 8.3.6; FDA 21 CFR 820.75

DVP&R (Design Verification Plan and Report)

A DVP&R is a living document listing every design requirement, the test that verifies it, the acceptance criterion, the sample size, and the pass/fail result. It is common in the automotive APQP process.

V-model diagram concept

User needs ──────────────────────── Validation ↓ ↑ System requirements ────── System test (verification) ↓ ↑ Design specifications ── Integration test ↓ ↑ Detailed design ─── Unit test

CQE exam tips

Verification references inputs; validation references user needs — the distinction is the comparison point.
Both are required by ISO 9001 and FDA 21 CFR 820; skipping one is a major nonconformance.

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