Quality Control (QC) encompasses the operational techniques and activities used within the Quality Management System (QMS) to fulfill quality requirements. In contrast to process-oriented Quality Assurance (QA), QC is a product- or result-oriented approach. QC activities are designed to identify defects in the generated outputs.
In clinical research, QC measures are integrated into daily workflows. Examples include the 100% review of a key document by a second staff member, Source Data Verification (SDV) by a monitor, the implementation of edit checks in the EDC system, or the statistical verification of analytical results. QC is an essential component of the work performed by every department within a CRO to ensure that the services provided meet the highest quality standards.