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This may happen because when a product or application is build as per the specification but these specifications are not up to the mark hence they fail to address the user requirements.
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Depending on the industry the instruments are built for and the individual requirements of the validation, other aspects might also need to be taken into account.
Essential Sections of Any Validation Plan Instrument validation begins with a validation master plan that defines the steps in each process.
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According to the Capability Maturity Model (CMM) we can also define validation as The process of evaluating software during or at the end of the development process to determine whether it satisfies specified requirements. A product can pass while verification, as it is done on the paper and no running or functional application is required.
But, when same points which were verified on the paper is actually developed then the running application or product can fail while validation.
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