Design Qualification (DQ)
Design qualification (DQ)- is on-going process to Demonstrate that the proposed design will satisfy all the requirements that are defined and detailed in the User Requirements Specification or design brief. Satisfactory execution of the DQ is a mandatory requirement before construction of the new design can be authorized.
- Verification and Validation plans
- Design Verification
- Design Validation
- Evaluation of Prototypes
- Preliminary Verification and Validation
- Documenting Verification and Validation for Regulatory req.
- Risk management
- Process Validation plan to ensure cGMP compliance as per FDA’s QSR