ABSTRACT
Computer systems are becoming increasingly sophisticated and more integrated, making the application of maximum validation rigor to the entire system impracticable. By the same token, applying a philosophy of “validation lite” to the entire system can severely dilute the value of the validation, both from the standpoint of the business value of the validation exercise and from the perspective of regulatory compliance. These considerations point to a need to optimize the efficiency of validation processes and development of appropriate validation strategies.
