Design Qualification is the key stage in the successful implementation of a project allowing identify gaps and assess risks at the design stage. The design qualification (DQ) documentation can’t be performed by the organization performing design as this can lead to a conflict of interest. Design qualification is a documented confirmation of suitability of the proposed design of premises, systems and equipment meeting intended purpose.
Design qualification should be performed for:
Design qualification has to demonstrate compliance with GMP requirements and the user requirements specification. It doesn’t include an assessment of the compliance with construction rules & regulations, electrical and fire codes and other requirements. We also provide services for assessing the compliance of the design with construction rules & regulations, electrical and fire codes and other requirements, as well as assessing energy efficiency and logistics.