The IQ-OQ package itself is real, not a myth.
However, the IQ-OQ package is necessary but insufficient
because it does not satisfy all the FDA’s requirements for
validating a computerized system. For example, the IQ-OQ
package does not include validation planning documentation
or validation summary reporting. The IQ-OQ package also does
not include requirement specification, user requirements, a
functional specification, or traceability from the IQ and OQ test
themselves to the user’s requirement either user requirements
or functional specification.