DQ

Design Qualification (DQ) is the formal review that confirms the proposed design — typically the supplier's FS and DS — satisfies the User Requirements. It happens before procurement / configuration starts. DQ is explicit in EU GMP Annex 15 (qualification & validation) and is best practice under GAMP 5.

DQ is usually a short structured document: each URS requirement mapped to where in the supplier's specs it is satisfied, plus a gap list (with mitigations) for anything not natively supported. V5 ships pre-filled DQ templates for each industry profile so the customer's QA team can confirm coverage in hours, not weeks.