Quality System Regulation Flashcards
7 cards from real RAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality System Regulation flashcards as text
Under 21 CFR Part 820, the Design History File (DHF) must contain or reference which of the following?
Answer: All records necessary to demonstrate that the design was developed in accordance with the approved design plan
§820.30(j) requires the DHF to contain or reference all records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of Part 820.
Which 21 CFR Part 820 section specifically addresses the requirement to identify, document, validate, and monitor software used as part of production or quality systems?
Answer: §820.70(i) — Automated processes
§820.70(i) requires validation of software used in production or quality systems, including establishing protocols for changes to that software.
When a manufacturer transfers a design to production, 21 CFR Part 820 requires which activity to ensure the device can be produced using the approved design?
Answer: Design transfer
§820.30(h) requires design transfer procedures to ensure that the device design is correctly translated into production specifications.
A manufacturer receives a complaint that a device caused patient injury. Under 21 CFR Part 820, the complaint file must include all of the following EXCEPT:
Answer: Name and address of the manufacturer's CEO
§820.198 requires complaint files to include the complaint date, complainant identity, device identification, investigation results, and corrective action — the CEO's identity is not required.
Under 21 CFR Part 820, which type of device is EXEMPT from design control requirements?
Answer: Class I devices that are not life-sustaining or life-supporting and have no substantial risk
§820.30(a) exempts certain Class I devices — specifically those not life-sustaining or life-supporting, not for a use substantially important to health, and not presenting a risk of serious injury — from design control requirements.
Under 21 CFR Part 820, corrective actions must be verified or validated to ensure they are effective. This verification must be:
Answer: Documented
§820.100 requires that the activities related to corrective action, including verification of effectiveness, be documented.
A manufacturer's calibration program must include which of the following according to 21 CFR Part 820?
Answer: Calibration intervals, calibration standards traceable to national standards, and out-of-calibration records
§820.72 requires calibration procedures, calibration intervals, traceable standards, and documentation of calibration activities including out-of-calibration findings.