Software Quality Assurance (SQA) refers to the processes and controls used to ensure software is developed, tested, and maintained to defined quality standards.
In regulated clinical environments, SQA supports validated systems by enforcing documentation, testing rigor, defect management, and controlled releases. SQA is closely tied to SDLC governance and helps ensure computerized systems are reliable and auditable. Strong SQA reduces the risk of system failures that could compromise data integrity or trial operations. Evidence of SQA practices is often reviewed during vendor audits and compliance assessments.