What is 21 CFR Part 11?
21 CFR Part 11 is an FDA regulation that governs the use of electronic records and electronic signatures. Essentially, it ensures that electronic data within regulated industries is as reliable and trustworthy as paper-based records and handwritten signatures.
Created in 1997, these regulations apply to all FDA-regulated industries, including pharmaceuticals, medical devices, and biologics, that use computer systems to create, modify, maintain, or transmit electronic records and signatures.
The core purpose of Part 11 is to ensure that:
- Electronic records are authentic, secure, and cannot be tampered with.
- Electronic signatures are legitimate and verifiable.
- Systems handling these records maintain data integrity through their entire lifecycle.
Simply put, the FDA wants to make sure your digital records are as reliable and trustworthy as traditional paper documents would be.
For a full breakdown of Part 11, click here.
How Part 11 Applies to Your LMS
Your LMS handles critical training records that demonstrate employee competence and compliance. To be Part 11 compliant, your LMS must provide the following features and functionalities that address key areas.
Electronic Records
Your LMS must ensure that all training records—including course completions, assessments, and certifications—remain:
- Accurate and complete
- Protected from unauthorized access or changes
- Available for FDA inspection throughout their retention period
- Backed up with appropriate disaster recovery protocols
Electronic Signatures
When learners or administrators sign off on training completion, course approvals, or competency assessments, these electronic signatures must:
- Include the signer’s printed name, date/time of signing, and meaning of signature
- Be uniquely linked to the signer with verification of identity
- Be executed with controls that prevent falsification
- Generate documentation that cannot be altered without detection
Data Security
Part 11 requires robust security measures, including:
- System access limited to authorized individuals
- User authentication protocols (username/password combinations or more advanced methods)
- Protection against unauthorized access to records
- Appropriate controls over system documentation
21 CFR Part 11 Training Checklist
When evaluating your LMS for Part 11 compliance, look for these critical capabilities.
System Validation
- Documented evidence that the system consistently performs as intended
- Testing protocols that verify system functionality
- Change control processes to manage system updates
User Controls & Authentication
- Unique user identification with secure login credentials
- Role-based access permissions
- Controls to prevent unauthorized use
- Password management policies including complexity requirements and expiration
Comprehensive Audit Trails
- Chronological record of system activities
- Documentation of who did what and when
- Tamper-evident logs that cannot be modified
- Retention of all record changes with original data preserved
Electronic Signature Components
- Two-factor authentication for signatures
- Name, date, time, and meaning of signature captured
- Link between signature and relevant electronic record
- Verification that signers understand legal implications
Document Controls
- Version control for training materials
- Secure archiving capabilities
- Ability to track document review and approval processes
- Retention policies aligned with regulatory requirement
System Security
- Data encryption for sensitive information
- Protection against unauthorized access
- Regular security testing and updates
- Backup and recovery procedures
How GyrusAim Supports Part 11 Compliance
We designed the GyrusAim LMS with Part 11 requirements in mind. GyrusAim provides life science organizations with the tools they need to maintain compliant training operations. GyrusAim offers the following features that life science organizations need.
Comprehensive Audit Trails
GyrusAim automatically tracks every action within the system with user identification, timestamps, and detailed information about the changes. These audit trails cannot be altered, ensuring the integrity of your electronic records.
Learn more about FDA audit readiness with GyrusAim.
Secure Electronic Signatures with PIN Verification
GyrusAim implements compliant electronic signature functionality that includes identity verification through PIN authentication. Once records are signed, they cannot be modified without creating a new entry in the audit trail, protecting the integrity of completion records.
Advanced Identity Management
User authentication protocols ensure that only authorized individuals can access the system, with robust password requirements and account lockout features preventing unauthorized access.
Comprehensive Version Control
GyrusAim LMS tracks all versions of training content, maintaining historical records of courses even as they evolve. This ensures that each learner’s training completion is associated with the specific version they completed, critical for regulatory documentation.
Immediate Access to Training Records
Authorized personnel can access complete training records at any time, enabling rapid response to audit requests or inspections. Reports are generated with built-in validation to ensure accuracy and completeness.
Validated System Architecture
GyrusAim undergoes rigorous validation testing, including over 130 quality assurance checks, to ensure consistent, reliable performance in regulated environments. Our validation approach aligns with GAMP 5 guidelines to support your compliance efforts.
Learn more about the unique demands of life sciences training.
Implementing a 21 CFR Part 11 Training Program
A 21 CFR Part 11 training program requires thoughtful planning and the right technology infrastructure. Beyond selecting a compliant LMS, organizations should:
- Develop clear standard operating procedures (SOPs) for system use
- Train employees on compliance requirements and proper system use
- Regularly review audit trails and system performance
- Maintain documentation of system validation
- Establish a change control process for system updates
Part 11 compliance isn’t just one-time project. It is an ongoing commitment to 21 CFR Part 11 training for data integrity and regulatory adherence.
By implementing a Part 11 compliant LMS like GyrusAim, life sciences organizations can approach regulatory inspections with confidence, knowing their training records maintain the integrity, security, and accessibility that regulators expect.
Sign up for a personalized free trial today to ensure GyrusAim is the right fit for your organization.
