Validation is defined as
A)conformance of a product or process with pre-established specifications
B)documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting predetermined specifications
C)monitoring performed to ensure that the quality system is being adhered to and is effective
D)standardization of an analytic instrument

Question

Quizplus · Accepted Answer

Validation is the documented evidence that a process will consistently produce a product meeting predetermined specifications. Conformance (A) is part of validation, but not the complete definition. C is describing monitoring for quality system adherence, not validation. D refers to standardization, but not necessarily validation.

Validation Is Defined as