CFR Gateway

CFR Gateway is designed to transform laboratory systems and instruments into compliant entities, adhering to regulations such as 21 CFR Part 11 and EudraLex Annex 11. This comprehensive solution provides secure access, ensuring only authorized personnel can interact with sensitive data and applications.

Key Features:

• Streamlined Access Control: Restricts data access to authorized users, maintaining the integrity of sensitive data.
• Role-Based Authorization: Allows administrators to manage data accessibility based on user roles, enhancing data security.
• Audit Trails: Monitors and records user activities with precise date and time stamps, ensuring complete traceability.
• Secure Data Storage: Lab data is stored on secure servers with robust version control, preventing unauthorized access and modifications.

The tool also ensures data integrity through version control, where any data modifications are systematically tracked and stored on secure servers. This measure not only ensures compliance but also significantly reduces the risk of data breaches.

Innovative Data Management:

• Comprehensive Audit Trails: Automatically generated upon each action, allowing for continuous data verification and integrity.
• User Activity Tracking: Logs user access and modifications, ensuring accountability and precise data management.
• Secured File Access: Limits file access to downloads from centralized secure servers, prohibiting unauthorized local access.

CFR Gateway is essential for labs seeking impeccable data integrity and regulatory compliance. By enforcing stringent access controls and maintaining comprehensive records of data usage and alterations, it solidifies the trustworthiness of lab data from creation to long-term storage.

This solution is widely adopted by leading pharmaceutical and life sciences organizations, providing them with peace of mind regarding data protection and compliance.