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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 . As per the european commission  definition, DQ is  the documented verification that the proposed design of the systems, facilities and equipment is suitable for the intended purpose. DQ  is also a shared responsibility between the user and the vendor of any equipment or an instrument: Design Qualification 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 valida...

Operational Qualification Design Qualification   Installation Qualification   Performance Qualification Operational Qualification is the part of instrument as well as equipment qualification and validation. So what is operational Qualification ? It is the documented collection of activities which are necessary to  demonstrate that an instrument or equipment will function according to its operational specification in the selected environment. Here during Operational Qualification more emphasis should be placed on " in the selected environment". Testing of instrument hardware at the user's site is required because instrument characteristics can change when shipped from the vendor to the user, for example through mechanical vibration. Major activities which are conducted during Operational Qualification are as follows: Tests that have been developed from knowledge or processes, systems and equipment. It also contain tests to include a condition or a set o...