FDA 21 CFR Part 820 Compliance Made Simple
Cloud-based quality and ERP software built to help medical device and life sciences companies simplify compliance with FDA quality system regulations.
Automated Document Control
QT9 QMS automates document approvals, revisions, and version control to ensure current procedures and specifications are followed, while maintaining alignment with related operational data.
FDA Audit Readiness
QT9 QMS provides full traceability and audit-ready records, with connected QT9 ERP data supporting production, inventory, and process visibility during FDA inspections.
Ensure FDA Compliance
QT9 QMS simplifies FDA 21 CFR Part 820 compliance with electronic signatures, controlled workflows, and integrated quality processes, supported by accurate operational data from QT9 ERP.
CAPA Management
QT9 QMS streamlines corrective and preventive actions with complete traceability to nonconformances, audits, and customer complaints, while QT9 ERP supplies relevant manufacturing and process data.
FDA 21 CFR Part 820 compliance for the modern medical device manufacturer
Explore how 21 CFR Part 820 compliance software can benefit your organization
Electronic Signatures and Audit Trails
Risk Management Integration
Design Controls and Change Management
Control product development changes with linked design inputs/outputs, verification/validation and approvals.
Complaint Handling
Nonconformance Tracking
Detect and manage deviations in real time with root cause analysis, disposition tracking and reporting.
Supplier Management
Qualify, approve, and monitor supplier performance with built-in supplier ratings and audit results.
Validation and Cloud Hosting
Pre-validated QMS with available validation documentation, hosted in a secure, validated cloud environment (AWS).
See how QT9 QMS and QT9 ERP stack up against 21 CFR Part 820 compliance
QT9 is available in the cloud or on-premise
Flexible deployment to match your IT strategy without compromising security or speed.
Work smarter with intelligent automation in quality and compliance
QT9 Software’s built-in automation streamlines compliance workflows, quality checks, and alerts, reducing human errors, accelerating decision-making and freeing your team to focus on higher-value work.
Speed up implementation with pre-validated software
QT9 Software offers a fully pre-validated environment, with every module and feature tested and documented for compliance. Save time, avoid costly internal validation processes and go live faster with confidence.
Ensure audit-ready traceability across all processes
Track every action, change and event in real time with QT9 Software. Timeline-based traceability supports inspections, audits and product recalls by providing complete visibility into your processes and product history.
Empower teams with secure, self-service portals
QT9 Software provides dedicated web portals for employees, suppliers and customers, enabling secure self-service access to documentation and data while streamlining collaboration across your organization.
Catch and resolve issues instantly with real-time monitoring
Monitor operations live with real-time dashboards and automated alerts using QT9 Software. Enable proactive responses to nonconformances, minimize downtime and improve compliance outcomes across your organization.
Onboard faster with an intuitive, user-friendly platform
Whether you’re a startup or an enterprise, QT9 Software’s clean, intuitive interface minimizes the learning curve, empowering users to work confidently, complete tasks accurately and stay audit-ready from day one.
FAQ: FDA 21 CFR Part 820
21 CFR Part 820 is a quality system regulation enforced by the U.S. Food and Drug Administration (FDA) with the goal of ensuring that medical devices are safe and effective for their intended use. The regulation is part of current Good Manufacturing Practice (cGMP) requirements for medical device manufacturers. Compliance with the regulation is required to market and distribute medical devices in the United States.
21 CFR Part 820 is important to medical device manufacturers working in the United States since compliance with the regulation is mandatory. Demonstrating compliance proves to the FDA, customers and the public that your company embraces quality processes and can reliably deliver medical devices that work as purported.
FDA 21 CFR Part 820 has 15 subparts labeled alphabetically. They are:
- General provisions
- Quality system requirements
- Design controls
- Document controls
- Purchasing controls
- Identification and traceability
- Production and process controls
- Acceptance (inspections and validations)
- Nonconforming product
- Corrective and preventive actions (CAPA)
- Labeling and packaging controls
- Handling, storage, distribution and installation
- Records
- Servicing
- Statistical techniques
FDA 21 CFR Part 820 is a national regulatory standard enforced in the United States, while ISO 13485 is an international standard outlining medical device quality management criteria. ISO 13485 is not mandatory in the United States, however it is the main quality guideline for several other countries, including much of Europe, Canada, Japan and Australia.
Outside of jurisdiction, the main difference between 21 CFR 820 and ISO 13485 is that ISO 13485 more completely follows a risk-based approach.
In January 2024, the FDA published a final rule amending 21 CFR Part 820. The change will officially bring FDA med device quality requirements more in line with ISO 13485. The revised part 820 is referred to as the Quality Management System Regulation (QMSR) and is scheduled to go into effect on February 2, 2026.
Manufacturing companies in FDA-regulated industries rely on QMS solutions that simplify compliance with regulations like FDA 21 CFR Part 820 and Parts 210-211. Top solutions include QT9 QMS, MasterControl, Veeva and Greenlight Guru.
QT9 QMS is particularly well-suited for manufacturers because it offers integrated quality management with Enterprise Resource Planning (ERP), ensuring traceability across production, supply chain and quality records. Features like automated CAPAs, electronic batch records and risk management tools help manufacturers maintain compliance while improving efficiency.
The best QMS software for FDA-regulated companies is one that:
- Offers a pre-validated environment, saving users time and speeding adoption
- Enables audit-ready traceability across all processes
- Provides real-time visibility for faster response to nonconformances
- Automates and integrates compliance workflows, quality checks and alerts
- Has an intuitive, user-friendly platform
QT9 QMS is a top choice for FDA-regulated companies because it offers validated compliance with 21 CFR parts 11, 210-211 and 820 (QSR, QMSR). QT9’s cloud-based platform, modular structure and seamless integration with QT9 ERP make it ideal for medical device, pharmaceutical and nutraceutical manufacturers who need both compliance assurance and operational efficiency.
QT9 QMS is a highly rated quality management solution geared toward regulatory compliance and efficient systems. We offer more than 23 modules that come standard, including Document Control, Audit Management, Nonconforming Products, Corrective Actions, Employee Training and Customer Feedback, as well as a Device History Record integration.
2024 will also see the release of our all-new Design History File application. All can help medical device manufacturers address FDA 21 CFR Part 820 and other regulations, such as ISO 13485.
Our QMS is backed by free software updates, full customer support, an available ERP integration and Business Intelligence tool. Call today for more information.
Explore more FDA compliance resources
FDA QMSR and the End of DMR, DHR and DHF
FDA QMSR Webinar Answers Common Industry Questions About the New Rule
Know the Facts About Software Validation in 2026
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