Cupertino, CA – July 7, 2019
In a major regulatory compliance achievement, iNDX.Ai has now tailored its SaaS-based iCore V4.0TM informatics platform to include compatibility of its documentation management suite with FDA’s Title 21 CFR Part 11 regulations.
This means that iNDX.Ai’s clients can have unprecedented control and assurance when managing electronic records and electronic signatures (ERES) within the iCore V4.0 platform.
So how exactly does this integration benefit iNDX.Ai’s clients?
About 21 CFR part 11 compliance
The Federal government codifies regulations for Food and Drugs industries under Section 21 of the Code of Federal Regulations (CFR). The clinical trial stakeholder that utilize electronic records and electronic signatures (ERES) are required to follow specific formats to be in compliance with the guidelines outlined within part 11 of this Section. FDA mandates this to ensure authenticity, confidentiality, and trustworthiness of electronic documents that are submitted to the FDA. Non-compliance from these regulations can have serious repercussions including heavy penalties and possible suspension of clinical trials when serious violations are recognized. In the current clinical trial environment, patient information and records generated during clinical trials can exist in both paper and electronic formats.
21 CFR part 11 compliance of iCore V4.0 ensures that electronic data itself and the hard copy documentation that is converted to electronic mode within the platform is maintained with a high degree uniformity, security, and is organized according to expectations set forth by the FDA. The compatibility of iCore V4.0 with these guidelines will also ensure that subscribes utilizing this platform are compliant right from the inception of the study. The compatibility will also ensure that clinical trial stakeholders can maintain this compliance throughout the study and prevent possible punitive actions from the FDA.
The incorporation of stringent compliance benchmarks within this platform represents a major competitive advantage for iNDX.Ai which has been striving to introduce continual improvements in its AI-based application suites.
About iNDX Technology, Inc
iNDX Technology, Inc (now iNDX.Ai) is a silicon valley based start-up that developed iCore, an innovative informatics platform to help its collaborators find a cure for cancer. iCore leverages modern technologies such as AI/ML/NLP to develops informatics products that are designed to help multiomic biomarker discovery in the translational research for immuno-oncology.
Vinayak Khattar. Ph.D., MBA.
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