What is the difference between Validation & Qualification?

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What is the difference between Validation & Qualification?..

Answer / d.mondal

Validation Validation is best described as the process of “establishing documented evidence” which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. Simply put, it is the act, process or instance to substantiate something on an reliable basis.

What are the examples for validation? Some include Design Validation, sterilization validation, process and software validation.

Qualification Qualification is described as the action of proving that any premises, systems and items of equipment work correctly and actually lead to the expected results. It is the process used to establish confidence that the equipment is capable of consistently operating within established limits and tolerances. Qualifications tend to be smaller in scope, more static in nature and are usually subsets for a greater validation initiative. Qualification allows for conduction of tests to be performed on one element or component of the process to be validated against a specified outcome. Simply put, it is the act or process to assure that something complies with an expected outcome, standard or a set of specific requirements.

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