SOC 2 & 21 CFR Part 11 Announcement

Voxeleron is now SOC 2 Type 1 certified and in compliance with FDA’s 21 CFR Part 11.

Taking excellent care of customer data is our highest priority, and we are invested in implementing security measures that follow all clinical research standards. Achieving and maintaining SOC 2 certification affirms Voxeleron will handle user data in accordance with strict standards across the five critical areas of security, availability, integrity, confidentiality, and privacy. Our operations adhere to the AICPA Trust Services Principles and Criteria, which cover the effectiveness and security of internal controls. Through this certification, Voxeleron customers will have full transparency into their data and be able to proactively address unauthorized access requests or other unusual activity. SOC 2 is the benchmark security compliance for any service organization, and we are proud to have achieved this standard as a company.

Voxeleron also reached another important milestone by certifying their compliance with 21 CFR Part 11 for their iNebula platform. 21 CFR Part 11 compliance is essential for research or clinical studies conducted in the U.S., as it certifies the security and authenticity of electronic data. Voxeleron implements versioning and a digital audit trail to track each action taken in the data management chain, including user access, data entry and editing, upload of images, review of images, quality control, and grading. This means any research or clinical study facility working with Voxeleron will be processing images and data following 21 CFR Part 11-compliant processes, meaning all electronic records are trustworthy and reliable.

These two significant achievements are part of Voxeleron’s ongoing expansion of its AI-enhanced ophthalmic image analysis and clinical trial management platform. If you are looking to learn more about advanced OCT analysis and efficient ophthalmic clinical trial management, contact us today to learn more and request a demo.