iNDX.AI’s iCore Data Analytics Platform receives GXP compliant certification
Cupertino, CA, February 12, 2021.
iNDX.Ai is excited to announce our GXP Compliance Certification from NADH+, an FDA-approved certification agency that evaluated iNDX.Ai systems and found us in compliance with the highest GXP standards of quality. GXP compliance entails implementing a rigorous system of documentation and records management and in the case of software solutions for healthcare and pharma, it means meeting the guidelines of CFR 21 Part 11 regulation. The CFR 21 Part 11 specifically deals with the creation, management, and destruction of electronic records and signatures and is the primary piece of regulation for which pharma companies must meet compliance requirements.
We are proud of our strong commitment to regulatory compliance and providing GXP compliant innovative software solutions to our pharma and biotech partners supporting their drug development endeavors. (www.indx.ai)
“We are proud of this milestone that shows our commitment to the regulatory compliance adding to iCore’s certifications of 21CFR Part 11, GDPR & HIPAA compliance” Mohan Uttarwar, CEO iNDX.Ai
“Regulatory compliance is of paramount importance for Pharma & Clinical Laboratories to ensure the quality & efficacy of their products to safeguard public health. iNDX.Ai is balancing the innovation and compliance with this certification.” Dr. Richard Friedberg MD, Ph.D., ex-President- College of American Pathologists, who lead several CAP/CLIA certification audits globally.
iNDX.Ai develops a software application suite to accelerate Precision Medicine by combining the innovations in life sciences with the innovations in data sciences to help scientists, researchers, and clinicians for multi-omics biomarker development to accelerate scientific discovery and clinical trials.