The FDA recommends a risk-based approach to validation, so it depends on the impact the system will have on quality, safety, and record integrity. Critical components are those that have impact on the integrity of the study. So components related to data and systems that an IRB may use to make their determinations when there are critical outcomes that will result from using these systems. In the draft guidance, the FDA provides examples of critical records such as records containing laboratory and study endpoint data, information on serious adverse events and study participant deaths, information on drug and device accountability and administration.
When using a risk-based approach for validating electronic systems, entities should consider (1) the purpose and significance of the record, including the extent of error that can be tolerated without compromising the reliability and utility of the record for its regulatory purpose and (2) the attributes and intended use of the electronic system used to produce the record.