This assessment is only concerned with ensuring that the degree of validation that is proposed; is compliant with the regulatory requirements.
The regulations state, that these configured systems must be validated for their intended use.
Over the course of several meeting the URS is fleshed out to document all aspects of the requirement.
It is essential that the document is properly scoped in order that the procurement , installation, commissioning, validation, user training, maintenance, calibration and cleaning tasks are all investigated and defined adequately.
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.