X3 Quality Systems obligations being verified
Management, Audits & DocumentsDesign Controls, DHF, DMR & DHRPurchasing, Production & ValidationCAPA, Complaints, MDR & RecallsTraceability, Labeling & RecordsManagement, Audits & DocumentsDesign Controls, DHF, DMR & DHRPurchasing, Production & ValidationCAPA, Complaints, MDR & RecallsTraceability, Labeling & Records
FDA · 21 CFR 820 QSR · CDRH · grounded in the regulation
The Quality System Regulation, audit-ready by obligation.
X3 Quality Systems turns 21 CFR 820 — management responsibility and internal audits, document control, design controls and the design history file, the DMR and DHR, purchasing and process validation, acceptance activities, nonconforming product and CAPA, complaint handling with the MDR and recall clocks, traceability, labeling, servicing and records — into a living compliance surface. Every duty carries the record an FDA investigator would ask for — not a summary, the artifact.
Reading live counts from the X3 genome…
What's covered
Five duty groups spanning the QSR's management, design, production, CAPA, and records regime — read live from the X3 genome (Cloudflare D1). Counts below are the real obligation totals and their evidence-completeness.
21 CFR 820.5 · 820.20 · 820.40
Management, Audits & Documents
5
obligations · 100% carry evidence
A quality system appropriate to the device, quality policy and management review, independent internal audits, trained personnel, and controlled documents with change history.
21 CFR 820.30 · 820.181 · 820.184
Design Controls, DHF, DMR & DHR
5
obligations · 100% carry evidence
Design and development plans, validation on initial production units with software validation and risk analysis, the design history file, the device master record, and the device history record.
21 CFR 820.50 · 820.70 · 820.75
Purchasing, Production & Validation
5
obligations · 100% carry evidence
Supplier evaluation and purchasing data, monitored production processes, calibration traceable to national standards, process validation where results cannot be verified, and acceptance before release.
21 CFR 820.100 · 820.198 · 803.50 · 806.10
CAPA, Complaints, MDR & Recalls
5
obligations · 100% carry evidence
Nonconforming product disposition, the CAPA engine with effectiveness verification, complaint evaluation and investigation, the 30-day MDR, and the 10-working-day corrections and removals report.
21 CFR 820.65 · 820.120 · 820.180
Traceability, Labeling & Records
5
obligations · 100% carry evidence
Control numbers for implantable and life-sustaining devices, labeling inspection and storage control, servicing reports as quality data, records readily available to FDA, and written sampling plans.
Evidence, not summaries
A sample of real obligations from the genome — each duty is paired with the concrete record an FDA-483 would ask you to produce.
21 CFR 820.100
Analyze quality data, investigate the cause of nonconformity, and verify or validate that the corrective action works.
Evidence: CAPA records with the investigation, root cause, actions taken, effectiveness verification, and closure approval
21 CFR 820.30(g)
Validate the design on initial production units under defined operating conditions, with software validation and risk analysis.
Evidence: Design validation report with the protocol, results, software validation, risk analysis, and approval signatures
21 CFR 803.50
Report to FDA within 30 calendar days of awareness of a death, serious injury, or reportable malfunction.
Evidence: Submitted MDR with its report number, the date of awareness, and the reportability decision record
21 CFR 820.75
Validate any process whose results cannot be fully verified by later inspection and test, and control its parameters.
Evidence: Process validation report with the protocol, results, approvals, and the qualified personnel performing it
X3 Quality Systems