21 CFR Part 820 — Quality System Regulation

Veridian Corp cross-reference mapping of FDA QSR requirements to internal SOPs and controls

CFR Part: 21 CFR Part 820

Title: Quality System Regulation

eCFR URL: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820

Veridian Document: FDA-COMP-001 Section 1.0

§820.30 — Design Controls

Each manufacturer shall establish and maintain procedures to control the design of the device to ensure that specified design requirements are met per 21 CFR 820.30(a).

Design input requirements shall be documented, reviewed for adequacy, and approved per 21 CFR 820.30(c).

Design output procedures shall define acceptance criteria and ensure outputs meet design input requirements per 21 CFR 820.30(d).

Design verification shall confirm that design outputs meet design inputs per 21 CFR 820.30(f).

Design validation shall be performed under defined operating conditions on initial production units per 21 CFR 820.30(g).

CFR Subsection	Requirement Summary	Veridian SOP
820.30(a)	General design control requirements	SOP-DES-001
820.30(c)	Design input documentation	SOP-DES-002
820.30(d)	Design output documentation	SOP-DES-003
820.30(e)	Design review meetings	SOP-DES-004
820.30(f)	Design verification testing	SOP-DES-005
820.30(g)	Design validation testing	SOP-DES-006
820.30(h)	Design transfer to production	SOP-DES-007
820.30(i)	Design changes control	SOP-CHG-001
820.30(j)	Design history file (DHF)	SOP-DES-008

§820.50 — Purchasing Controls

Each manufacturer shall establish and maintain procedures to ensure all purchased or received product and services conform to specified requirements per 21 CFR 820.50.

Suppliers shall be evaluated and selected based on ability to meet specified requirements including quality requirements per 21 CFR 820.50(a).

Purchasing data shall clearly describe or reference specified product and quality requirements per 21 CFR 820.50(b).

§820.70 — Production and Process Controls

Production processes shall be controlled to ensure devices conform to specifications per 21 CFR 820.70(a).

Process validation is required when process results cannot be fully verified by subsequent inspection per 21 CFR 820.75.

Environmental control requirements must be documented and monitored for all cleanroom and controlled manufacturing areas.

§820.198 — Complaint Files

Each manufacturer shall maintain complaint files per 21 CFR 820.198; each complaint shall be evaluated to determine if it represents an event reportable to FDA under 21 CFR 803.

Complaint records must include the device name, date complaint received, complainant name, nature of complaint, and investigation results.

Complaints involving death or serious injury must be reviewed by the Regulatory Affairs team within 24 hours of receipt.