21 CFR Part 820 for FDA Compliance
Quality Built for FDA Expectations
Bring documents, design controls, production records, CAPA, and audits together through a connected QMS built to support FDA inspections.
Faster Audit Prep
Faster CAPA Closure
Audit-Ready Uptime
Less Manual Effort
Record Traceability
ISO 9001 Aligned
What is FDA 21 CFR Part 820
21 CFR Part 820 establishes the FDA Quality System Regulation for medical device manufacturers. It outlines the quality system requirements needed to control product design, manufacturing, process validation, complaint handling, CAPA, and documentation across the device lifecycle.
Benefits of 21 CFR Part 820 Compliance Software
FDA inspections examine more than documents. They examine how quality activities are planned, recorded, reviewed, and connected across the organization.
TALK TO A QUALITY EXPERTDesign Controls
Maintain complete design records from planning across validation with documented reviews, approvals, and Design History Files.
Controlled Documentation
Keep procedures, specifications, forms, and quality records under revision control with complete approval history and electronic signatures.
CAPA Management
Capture quality issues, investigate root causes, document corrective actions, and follow progress with a structured CAPA process.
Production Controls
Connect manufacturing activities, device records, inspections, and process controls through documented quality workflows.
FDA Inspection Readiness
Produce complete audit trails, electronic records, and supporting evidence without searching via disconnected systems.
End-to-End Traceability
Connect design changes, production records, complaints, CAPA, and audits with a complete quality history that supports regulatory review.
Which Qualityze Solutions Support the Requirements of 21 CFR Part 820?
21 CFR Part 820 requires quality activities to be documented, controlled, and consistently executed. Qualityze connects the core quality processes that help medical device manufacturers demonstrate compliance during FDA inspections.
Capture design planning, reviews, verification, validation, and Design History Files via documented workflows that support every stage of product development.
- Document Management
- Change Management
Five Steps to FDA 21 CFR Part 820 Compliance Software
A connected quality process that supports FDA Quality System Regulation requirements from design through post-market quality activities.
Step 1
Build a Controlled Quality System
Define quality procedures, assign responsibilities, and establish documented processes aligned with FDA Quality System Regulation requirements.
- Quality Procedures
- Document Control
- Quality Planning
From Inspection Pressure to Inspection Readiness
BEFORE QUALITYZE
Quality Records Scattered Across Systems
- Quality records are spread across multiple systems and manual files.
- Design changes require extensive effort to trace across product records.
- CAPA, complaints, and nonconformances operate in separate workflows.
- FDA inspections trigger document collection from multiple sources.
- Audit trails remain incomplete across quality activities.
AFTER QUALITYZE
Quality Records Connected End to End
- Documents, design controls, CAPA, complaints, and production records stay connected.
- Every quality change includes controlled approvals and revision history.
- Quality events follow a consistent path from identification to closure.
- Complete audit trails keep FDA inspection evidence readily available.
- One connected QMS provides lifecycle-wide traceability.
Ready for Every FDA Inspection?
Explore how Qualityze helps medical device manufacturers control quality processes, and support FDA 21 CFR Part 820 quality system regulation compliance in one connected Quality Management System.