Quality Assurance (QA) is the planned, systematic set of activities used to ensure clinical research processes and outputs meet applicable requirements and quality standards.
QA typically includes audits, vendor qualification, quality oversight plans, and assessment of compliance with SOPs, GCP, and regulatory expectations. Unlike day-to-day operational checks, QA provides independent verification that systems and processes are working as intended. QA findings often trigger CAPA to address root causes and prevent recurrence of compliance issues. Strong QA programs improve inspection readiness by demonstrating controlled processes, documented oversight, and continuous improvement.