How a Quality Management System Can Ensure Compliance With FDA 21 CFR Part 820
21 CFR Part 820 contains a huge number of “shall” requirements for medical device manufacturers. While it may seem impossible to meet so many requirements, a well-constructed Quality Management System (QMS) provides an excellent starting point and framework for compliance.
So how can manufacturers use the QMS to demonstrate compliance with these regulations, and which tools are most important to getting the job done?
Today’s post looks at just that, focusing on 7 specific capabilities to leverage in the QMS to assist with 21 CFR Part 820 compliance.
1. Document Control
The U.S. Food and Drug Administration (FDA) wants to see that you do what you say and say what you do. When it comes to quality system regulation, what are we looking for here?
In this sense, an automated QMS with Document Control tools is a big advantage, providing a centralized location for tracking key documents and managing permissions. If you can get this one key process down, you’ll save yourself a lot of trouble when it comes to compliance.
2. Employee Training Requirements
The FDA requires manufacturers to establish and document Employee Training so that people have the knowledge and skills to do their jobs effectively. An integrated QMS can help document compliance with employee training requirements, allowing you to link training to areas like:
3. Audit Management
According to FDA regulations, medical device manufacturers must conduct periodic quality audits to determine the effectiveness of the quality system. Audit Management tools within the QMS can help you demonstrate compliance with these requirements, allowing you to:
4. Reporting
Effective quality reporting goes a long way towards demonstrating compliance with FDA requirements. With so many companies still relying on outdated spreadsheet reporting, being able to access data on demand makes a much better impression on inspectors. Centralized Reporting tools provide evidence for a range of quality activities, from nonconforming product management to effectiveness of Supplier Quality Management activities.
More importantly, it helps you pull together the big picture of quality and compliance in your organization to better protect patient safety. Integrated Reporting tools in a robust QMS also help you share results with leaders and engage them in the quality process—a key focus of 21 CFR Part 280.
5. Supplier Management
The regulations contain several requirements related to purchasing controls and supplier management. That’s why it’s so important that any QMS covers Supplier Quality Management, helping you maintain records of:
6. Corrective and Preventive Action (CAPA)
Having effective Corrective and Preventive Action (CAPA) processes and tools is an essential part of FDA compliance. Tools in the QMS that will help you comply with these requirements include:
7. Risk Management
Leveraging Risk Management tools in the QMS can help improve quality and safety of devices while also showing a proactive approach to compliance. Applying risk assessments to different parts of the QMS process helps you make better decisions, in areas such as:
Risk assessments help record the why behind important decisions. Ultimately, a company that’s serious about risk management shows compliance not just with the letter of the law, but also the intent behind it. That type of authentic commitment is something that will shine through in everything you do, both to regulators and consumers in general.