Design Specification (DS) and Design Qualification (DQ)Shilpa Desai
Very “synonymous words”, DS and DQ, and can many a time be misleading, We might want to say one but speak the other and then would need clarifying.
One of the set of such words include – Design Specification (DS) and Design Qualification (DQ).
If we have to simplify what actually these two (Design Specification (DS) and Design Qualification (DQ)) are… It can be very simply explained as:
Design Specification (DS):
A design specification (DS) is a detailed document providing information about the characteristics of a project to set criteria the developers will need to meet. This would include the essential qualitative and quantitative characteristics of set of criteria. For example, for software the DS would be a document describing the design and architecture of the page, the interface and component levels, the working of the page, see that it satisfies the design parameters and performance specifications.
Essentially, the DS is the document which details the functional specification (FS) – the method in which the requirements are served, the configuration settings, the set parameters, etc. it may include the technical details – input fields, filed types, technical measures to ensure the working of the requirements, output, security, etc.
Design Qualification (DQ):
Per GAMP (GAMP® Good Practice Guide: Validation of Laboratory Computerized Systems), a design qualification (DQ) is a documented review of the design, at an appropriate stage in a project, for conformance to operational and regulatory expectations.
Per ISPE (ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition), a design qualification (DQ) is a documented verification that the proposed design of the facilities, equipment, or systems is suitable for the intended purpose.
DQ is a verification that the design meets the requirements and the documents would include:
1. Requirements (UR) – Design meeting GxP and User requirements
2. Specifications (FS)
3. Vendor assessment and qualification