What is 21 CFR Part 820?

21 CFR Part 820 is a critical section of the United States Code of Federal Regulations (CFR) outlining the Quality System Regulation (QSR) for medical device manufacturers. It serves as the FDA's Current Good Manufacturing Practice (CGMP) standard, ensuring the design, production, and distribution of safe and effective medical devices.

Compliance with 21 CFR Part 820 is more than a regulatory requirement—it’s an assurance of your organization’s commitment to quality, patient safety, and operational excellence.

Benefits of 21 CFR Part 820-Compliant QMS Software

Achieve Full Compliance

Ensure adherence to 21 CFR Part 820 requirements by automating critical tasks like document control, change management, and CAPA. Qualityze minimizes errors and omissions, freeing your team to focus on innovation and improvement.

Streamline Processes for Efficiency

Optimize workflows and reduce redundancies to accelerate product development, cut operational costs, and improve customer satisfaction. Qualityze transforms compliance from a burden to a competitive advantage.

Enhance Traceability and Transparency

Track and trace products, materials, and processes seamlessly. Qualityze's robust traceability features help you quickly identify issues, streamline investigations, and maintain compliance with traceability requirements.

Empower Data-Driven Decision-Making

Leverage real-time analytics and insights to make strategic decisions. Identify trends, address problem areas proactively, and continuously improve your quality system for better outcomes.

Mitigate Risks Effectively

Proactively identify, assess, and manage risks to reduce the likelihood of product recalls and compliance issues. Qualityze provides a structured approach to risk management, enhancing safety and operational resilience.

Ensure Regulatory Readiness

Prepare for FDA inspections and audits with confidence. Qualityze's centralized, automated system ensures your records are accurate, accessible, and audit-ready at all times.

Sub-Part B: Electronic Records

11.1011.30 Controls for closed systems. Controls for open systems.	A unique UserID and password is required to access the system User account should be in active status Access to Modules is required to create, edit, view records Electronic Signature is required to create, edit, approve, reject and/or delete any records Detail report can be used to print the human readable format of the record Inactivity will auto-log out the users from the system. The system uses Hypertext Transfer Protocol Secure (https) is a combination of the Hypertext Transfer Protocol (HTTP) with the Secure Socket Layer (SSL)/Transport Layer Security (TLS) protocol. TLS is an authentication and security protocol widely implemented in browsers and Web servers. SSL works by using a public key to encrypt data transferred over the SSL connection. Most Web browsers support SSL. It allows you to communicate securely with the web server.
11.50 Signature manifestations.	Electronic Signature Functionality. The system prompts the user to key-in the user id and password for create, edit, approve and delete actions within the system. When the create, edit, approval, reject and/or delete action is executed, the system captures: The name of the user who executed one of the functions The date and time the user executed the function; and The meaning of the action performed such as (author of the record, approval or rejection of the record).
11.70 Signature/record linking.	Audit Trail Functionality along with electronic signature functionality with Date & Time Stamping for all records related description. It ensures to capture details for each and every system entry done for all the records including the previous and current change value/description.
Sub-Part B: Electronic Signatures
11.100 General requirements.	Electronic signature of a user is unique combination of a user-id and password. A user-id and associated with a user who can be further identified by their Name (FN, LN), Title, email address and a phone number (optional) in the system.
11.200 Electronic signature components and controls.	To gain access to the system, a user must input two distinct identification components: User-id Password (see 11.300 controls for identification codes/password) Once logged in the system, any create, edit, approve, reject, delete action required re-entering the user-id and password combination.
11.300 Controls for identification codes/passwords.	User-id and password policy management is controlled by the designated administrator of the system. Each user is assigned a unique user-id to gain access to the system Creating a password must adhere to the policy below: A password must contain at least eight characters, including one alphabetic character and one number. The security question’s answer can’t contain the user’s password. When users change their password, they can’t reuse their last three passwords. A password can’t contain a user’s username and can’t match a user’s first or last name. Passwords also can’t be too simple. For example, a user can’t change their password to ‘password’.

21 CFR Part 820 Made Simple with Qualityze