What is FDA 21 CFR Part 11?

21 CFR Part 11 is a regulation issued by the U.S. Food and Drug Administration (FDA) that defines the requirements for electronic records and electronic signatures in FDA-regulated industries such as pharmaceuticals, biotechnology, and medical devices. It ensures that digital records are trustworthy, reliable, and equivalent to paper records, helping organizations maintain data integrity, security, and traceability in electronic systems.

Why is FDA 21 CFR Part 11 Important?

Life sciences companies rely on electronic records for research, development, and regulatory submissions. FDA 21 CFR Part 11 sets standards for how these records must be stored, accessed, and signed to prevent unauthorized modifications, loss, or non-compliance. Failure to comply can lead to regulatory penalties, data breaches, and setbacks in product approvals.

What are the Key Requirements of 21 CFR Part 11?

To comply with FDA 21 CFR Part 11, electronic record-keeping systems must include:

• Electronic Signatures – Must be unique to each user and linked to specific records.
• Audit Trails – Systems must automatically log any changes, including timestamps and user details.
• Access Controls – Role-based permissions ensure only authorized personnel can access or modify records.
• System Validation – Digital systems must be validated to demonstrate consistent, reliable performance.
• Data Security & Retention – Electronic records must be securely stored, backed up, and easily retrievable for regulatory inspections.

How Labguru Helps You with FDA 21 CFR Part 11 Compliance

Labguru provides a validated electronic lab notebook (ELN), LIMS, and inventory management system designed to support FDA 21 CFR Part 11 compliance. With Labguru, you can:

• Ensure Secure Electronic Signatures – Legally binding signatures with authentication and audit trails.
• Maintain Comprehensive Audit Trails – Automatic logging of all data modifications with timestamps.
• Implement Strong Access Controls – Role-based permissions and multi-factor authentication prevent unauthorized access.
• Validate Your Digital Systems – Labguru follows industry best practices for validation, ensuring compliance.
• Protect & Retain Data Securely – Encrypted cloud storage with regular backups for regulatory requirements.

By using Labguru, you can streamline compliance, enhance data integrity, and reduce the administrative burden of maintaining FDA-compliant digital records.