Understanding FDA 21 CFR Part 11
FDA 21 CFR Part 11 is a regulation set by the U.S. Food and Drug Administration (FDA) that establishes criteria for electronic records and electronic signatures. It ensures that digital records are as trustworthy and reliable as traditional paper records and handwritten signatures.
This regulation applies to organizations in FDA-regulated industries, including pharmaceutical companies, medical device manufacturers, and biotech firms, that rely on electronic records to manage compliance and quality control.
Key Requirements of FDA 21 CFR Part 11
To comply with this regulation, companies must meet several essential requirements:
Electronic Records
- Ensure authenticity, integrity, and confidentiality of data
- Implement audit trails to track changes and system activity
- Validate computerized systems to confirm proper functionality
Electronic Signatures
- Use unique, verifiable, and secure electronic signatures
- Maintain linkage between signatures and associated records to prevent unauthorized modifications
Compliance Challenges for Organizations
Achieving compliance can be complex due to several challenges, including:
- System Validation: Ensuring software performs its intended functions consistently
- Data Integrity: Protecting data accuracy and preventing unauthorized alterations
- Audit Trails: Maintaining a secure, time-stamped record of user actions
How Busitech’s SPC Software Simplifies Compliance
At Busitech, we understand the importance of regulatory compliance. Our SPC software provides robust solutions to help organizations meet 21 CFR Part 11 requirements seamlessly.
Comprehensive Audit Trails
Our software automatically records all user actions, ensuring a secure and time-stamped audit trail that satisfies FDA requirements. End-user actions, such as adding, editing, or deleting data, are tracked alongside administrative changes to the QW application structure, providing full transparency and compliance.
Advanced Access Controls
With customizable user permissions and integration with Windows or Active Directory (AD) user authentication, you can ensure that only authorized personnel have access to electronic records, reducing compliance risks and simplifying user the log in experience.
System Validation Support
We assist in validating our software, ensuring that it performs its intended functions and meets regulatory standards.
Data Integrity Assurance
Our SPC software protects data throughout its lifecycle, preventing accidental or unauthorized modifications.
Why Choose Busitech for Compliance?
- Streamlined Compliance: Our software is designed to simplify 21 CFR Part 11 adherence.
- Enhanced Efficiency: Automate data collection and analysis to reduce manual work and human error.
- Robust Security: Ensure your data is protected with industry-leading security measures.
See our PDF Guide: Meeting the 21 CFR part 11 requirements with Quality Window for further details.
Take the Next Step Toward Compliance
Ensure your organization meets FDA 21 CFR Part 11 requirements with ease. Contact us today to discuss your compliance needs or request a demo of our SPC software.