Design Qualification: Let us find out what is the definition of (DQ)? It is the widely asked question while studying qualification of any instrument or equipment. It is the documented collection of activities which define the functional as well as operational specifications of any instrument and the criteria for selection of the vendor based on the intended purpose of the instrument.
The responsibility of any vendor during DQ are:
- To develop and manufacture instruments in a quality control environment.
- To Develop functional and operational product specification.
- To Provide information on how software and instruments are validated during development and supported during the entire life of the products.
- To Allow user audits, if required, and share approaches for development and testing.
The responsibility of any user during DQ are:
- To Describe the problem analysis and selection of the technique.
- To Describe the use which is intended.
- To Describe the environment which is intended (including computer environment).
- To identify or select and document the performance and functional specifications (technical, environmental, safety).
- Select and assess the vendor.