Validate the requirement, not just the test
Ask a validation team where their time goes and the answer is usually test scripts: writing them, reviewing them, executing them and dealing with the failures. That is where effort is visible. It is rarely where the problems begin.
Tests inherit the quality of the requirement
A test case proves that a system does what a requirement says. If the requirement is incomplete, the test passes and the gap survives. It surfaces later as a deviation during execution, a finding during an audit, or a change request after go-live.
A common example is the audit trail. A URS states that “the system shall record the user, date and time of every change”. It reads well and it is testable. But 21 CFR 11.10(e) also expects that record changes do not obscure previously recorded information. If the requirement does not ask for the previous value to be kept, neither the design nor the test will check it.
Why gaps are found so late
URS and design reviews are usually done by people under time pressure, reading long documents against their own memory of the regulations. They catch a lot. They cannot reliably catch everything, and the gaps they miss are the ones nobody thought to look for.
By the time testing starts, the design is built or configured. Fixing a missing requirement now means changing the design, updating the risk assessment, rewriting tests and re-approving documents.
Moving the check upstream
The cheapest point to fix a requirement is before anything is built to it. That means reviewing the URS and design specification systematically against the regulations and good practice that apply, and doing it early enough that the answer can change the design.
This is the step dAInta was built around. It checks each requirement and design item against GxP expectations, explains every gap it finds with the clause behind it, and leaves the decision with your reviewers. Testing then starts from requirements that are complete.
Validation will always need good tests. It needs good requirements first.