Qualification is documented evidence that a specific equipment, facility or system is fit/ready for intended use. It is further divided into DQ, IQ, OQ & PQ.
1. Qualification : V-Model Approach
V- Model Approach: It is called the V-model because of its characteristic “V” shape. The left arm of the “V” represents the planning / specification phases such as User Requirements Specification, Functional Specification, Detailed Design, and the right arm of the “V” represents the execution-validation phases such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) and both the arms converge at the Build and Unit Testing phases at the V-Point.
2. Qualification Matrix
Qualification Matrix: Action of proving and documenting that equipment or ancillary systems are properly installed, work correctly, and actually lead to the expected results.
3. Qualification Activity Matrix
Qualification is documented evidence that a specific equipment, facility or system is fit/ready for intended use.
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