DS
Design Specification · design spec · design specification
How the system is technically built — the lowest validation tier, owned by the supplier.
The Design Specification (DS) describes the technical implementation: database schema, integration interfaces, infrastructure, security model, code modules. Under GAMP 5 it is typically owned by the supplier and not authored fresh per customer; the customer references the supplier's DS in their validation pack.
For V5, the DS covers the multi-tenant data model, RLS enforcement, audit-trail storage (append-only, hash-chained), e-signature implementation against 21 CFR 11.50/11.70/11.200, and the SSR + serverless runtime. Customers receive the DS as part of the validation pack so their internal QA can review it without recreating it.
- GAMP 5