What is the difference between Validation and Qualification?

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Validation of a computer system may be divided in more manageable pieces. Often these are called Qualifications. Validation is generally known as the combined efforts of three or four qualifications, but any number of qualifications (or other division of the work) may be used as long as it has been defined what each piece comprises. The description of how to divide the validation effort is made in the Validation Plan. In these examples “qualifications” are used, but the principle is the same if the tasks are defined differently.

Note that there are several ways to define what each qualification comprises. None are probably incorrect, and most are correct. The main thing is to define it, and stick to the definition. Preferably this shall be defined for the whole company in order to handle validation in a consistent way. See 11x01 validation model below.
• DQ - Development Qualification
• IQ - Installation Qualification
• OQ - Operation Qualification
• PQ - Performance / Process Qualification

The main differences are generally whether OQ and PQ can be done at the same time or not, and whether PQ is before the system goes live or also included the live phase of the system.

Table 11x01: Validation Model

Table 11x01: Validation Model