Quick Guide to 21 CFR Part 820 Requirements
Manufacture Safe and Effective Medical Devices
The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 820 Quality System Regulation (QSR) details the requirements governing the manufacture of safe and effective medical devices sold in U.S. markets. Our new guide is an easy-to-understand overview of the regulation and your responsibilities for achieving compliance with the U.S. FDA's expectations. You will learn:
- The purpose of FDA 21 CFR Part 820 in medtech manufacturing.
- The fundamentals of 21 CFR Part 820 QSR compliance.
- Key aspects of an effective quality management system (QMS).
- How regulatory compliance software facilitates compliance with 21 CFR Part 820.
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21 CFR Part 820 Compliance FAQ
What are the key components of a Quality Management System (QMS) under Part 820?
The QMS components of the 21 CFR Part 820 quality system regulation include the organisational structure, responsibilities, processes, and resources for implementing quality management in medtech manufacturing.
How does Part 820 apply to European medical device manufacturers?
While manufacturers in the EU are familiar with adhering to the EU Medical Device Regulation, marketing their products in the U.S. requires them to meet Part 820 regulatory requirements.
What are the consequences of non-compliance with Part 820?
Companies found to be noncompliant with FDA 21 CFR Part 820 could receive a warning letter from the regulatory agency, experience a product recall, or have the organisation completely shut down.
How can I prepare for an FDA inspection or audit under Part 820?
Deploying regulatory compliance software is the best way to prepare for inspections and comply with FDA 21 CFR Part 820. Automating and integrating all quality tasks ensures quality throughout the product life cycle.
Essential Components of 21 CFR Part 820 QSR
The 21 CFR Part 820 QSR contains detailed regulations manufacturers must comply with. The following are key components of the regulation.
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Risk Management
Risk management is pivotal to 21 CFR Part 820 compliance. It must be applied throughout product development, design change, manufacturing, and postmarket surveillance.
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Document Control
Manufacturers are required to establish and maintain procedures for creating, controlling, updating, and archiving documents.
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Corrective Action/Preventive Action (CAPA)
Manufacturers must identify, investigate, and prevent the recurrence of product and quality problems. This demonstrates that their quality system is effective.
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Equipment Maintenance
Manufacturers must ensure that all equipment meets specified requirements, including being appropriately designed and receives the required maintenance, calibration, and cleaning.
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Consistently Achieve 21 CFR Part 820 compliance
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Effective Document Control
Eliminate labour-intensive quality management tasks with a collaborative workspace, automated document control, and integrated enterprise management systems.
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Error-Free Records
Input data directly into tablets or computers. Digital records don’t accept out-of-specification (OOS) or omitted entries, so all records are error-free.
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Simplify CAPA Compliance
All stakeholders have visibility into all CAPA processes all the time. Connecting appropriate personnel with system data empowers them to make improvements on the spot.
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Integrated Risk Management
Employ a digitally connected, data-driven approach to identifying and mitigating risks before they result in costly delays, rework, or product recalls.
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Minimise Equipment Downtime
Regulatory compliance software manages your maintenance schedule and automatically triggers maintenance tasks before they are due.
21 CFR Part 820 Compliance Requirements
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The Key to 21 CFR Part 820 Compliance
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