Design Qualification [DQ]

Design Qualification [DQ]

Documented evidence that, for example, the premises, supporting systems, utilities or equipment have been designed for their intended purposes and in accordance with the requirements of good manufacturing practices.

• The premises, supporting systems, utilities or equipment shall be designed according to User User Requirements Specification (URS)

• Design Reviews / Qualification provide assurance that the design deliverables are consistent with the User Requirements Specification and the mitigation control strategies determined during the System Risk Assessment.

• if the Design qualification is performed properly; it can reduce the costly design-related change at a later stage.

• Design Qualification provides documented evidence:

  • 1. The Procured system or equipment meets User Requirements Specification,
  • 2. equipment adequately controls risk as identified during the system risk assessment and
  • 3. that Critical aspects/Critical Design Elements necessary to implement requirements and risk controls are present
  • 4. Design Review and Design Qualification are not intended to be separate activities.

• The Design Review feeds the Design Qualification via the requirements traceability matrix. Design Qualification is focused on Critical aspects and Critical Design Elements and involves the Quality unit as an approver.