CFR 21 Part 11 Compliance Support

Reliable Laboratory Information Systems for Hospital Environments
Hospital laboratories operate in complex, highly regulated environments where accuracy, reliability, and system integration are critical. Aspyra’s CyberLAB LIS is designed to support hospital-based laboratories with dependable workflows, secure data handling, and seamless connectivity across clinical and administrative systems.

Supporting Electronic Records & Signatures

CyberLAB LIS provides functionality intended to support CFR 21 Part 11 requirements related to electronic records and electronic signatures, including:

Secure user authentication
Role-based access controls
System-enforced permissions
Controlled electronic record access

These capabilities help laboratories maintain accountability, data integrity, and controlled system use.

Audit Trails & Data Integrity

CyberLAB LIS includes comprehensive audit and logging features that support regulatory review and internal oversight.

User Activity Tracking

Tracks user interactions within the system to help maintain accountability and transparency across laboratory operations.

Event Logging

Logs record creation, updates, and modifications to support regulatory review and internal quality oversight.

Tamper-Resistant Audit Data

Helps protect audit information from unauthorized alteration, supporting data integrity and compliance requirements.

Workflow Traceability

Maintains traceability across laboratory workflows to support inspections, reporting accuracy, and operational oversight.

Secure System Access

To help protect patient data and laboratory records, CyberLAB LIS supports:

01

Automatic Session Controls

Helps prevent unauthorized access by automatically managing inactive sessions.

02

Secure Credential Handling

Protects user credentials through controlled authentication processes and secure data handling practices.

03

Configurable Access Privileges

Allows laboratories to define user roles and permissions to ensure appropriate system access.

04

Controlled System Entry & Exit

Supports secure login and logout processes to help maintain system integrity and accountability.

These controls help laboratories meet security expectations while maintaining efficient workflows.

Built for Long-Term Compliance

Aspyra understands that regulatory compliance is an ongoing responsibility. CyberLAB LIS is designed to support laboratories with stable, dependable systems that can be maintained over time as regulatory requirements evolve.

For organizations requiring additional certification or reporting disclosures, related compliance information is available on our ONC Certification & Costs page .

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Get in Touch

If you have questions regarding CFR 21 Part 11 support within CyberLAB LIS, our team is available to assist.

📞 Sales: (800) 437-9000
📧 Email: contact@aspyra.com