Definition of the Term Validation

Validation is documented evidence that provides a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality attributes. 

After the requirement for each aspect is determined, the responsible engineers complete the design and it is again reviewed by the validation team. After the approved designs are constructed and/or installed, the validation cycle continues with the preparation and execution of the validation documents. 

Validation is a systematic approach to gathering and analyzing sufficient data that will give reasonable assurance (documented evidence), based on scientific judgment, that a process, when operating within specified parameters, will consistently produce results within predetermined specifications. 

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There are various definitions of the term validation . The IAEA (Radioactive Waste Management Glossary 1988) definition is Validation is a process carried out by comparison of model predictions with independent field observations and experimental measurements. A model cannot be considered validated until sufficient testing has been performed to ensure an acceptable level of predictive accuracy. (Note that the acceptable level of predictive accuracy is judgmental and will vary depending on the specific problem or question to be addressed by the model.) ... 

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