Quality Assurance (QA) comprises all planned and systematic activities implemented within a Quality Management System (QMS) to ensure that a study is conducted in accordance with GCP guidelines and applicable regulatory requirements, and that the data generated are reliable. QA is a proactive, process-oriented approach aimed at preventing errors from the outset.
In a CRO, the QA department is independent of the operational study teams. Its primary task is to review processes, not the data itself. This is done by conducting audits (e.g., of systems, investigational sites, or study documentation), reviewing SOPs, and monitoring compliance with quality standards. QA ensures that the quality assurance system functions effectively, while Quality Control (QC) verifies whether the results meet the standards.