Regulatory Affairs Certification (RAC) 2025 – 400 Free Practice Questions to Pass the Exam

The correct answer indicates that annual audits of operations are not specifically a requirement outlined in the Quality System Regulation (QSR) for manufacturers of finished devices. The QSR, established by the FDA under 21 CFR Part 820, emphasizes the importance of quality systems and requires various activities to ensure that devices are consistently produced and controlled according to quality standards.

Quality audits conducted by external personnel are indeed a part of the QSR, as they help maintain an objective assessment of compliance and efficacy of the quality system. Documenting quality audit results is also essential because it creates a record that can be reviewed and used for further analysis and improvement of the quality systems in place. Management reviews of findings are mandated by the QSR as well, ensuring that senior management is actively engaged in reviewing the performance of the quality system and addressing any highlighted issues.

In contrast, while regular audits are critical for maintaining quality, the QSR does not delineate a requirement for annual audits of operations specifically. Instead, the focus is on ensuring that quality audits, regardless of frequency, are effectively implemented and that operations comply with all necessary quality regulations.