The regulation relates to the Title 21, Code of Federal Regulations Part 11 scope, covering the use and signing of electronic records.
This allows medical annotations made on V7 to be trusted as much as paper records and ink signatures. Now that V7 can prove that its annotations comply with Part 11, the FDA will accept their electronic signatures, allowing doctors to collaborate on our platform in an entirely paperless and cloud-based fashion. Regulated records submitted to the FDA as part of their approval process require valid signatures capturing several requirements summarized on the FDA's website.
For the development of AI, this means that every stage of the annotation process is signed off by the author with an immutable timestamp and a record of the signature. Several other requirements have passed our audit process, including the user permissions required for compliance, and improvements to our authentication system. This work is part of our continued commitment to making AI a tool we can leverage to solve humanity's biggest problems in the life sciences field, among others. Three years from inception, V7 is having lasting, real impact on research that will one day lengthen, improve, and save the lives of millions.
To learn more about our FDA Part 11 compliance, get in touch with our team.
If you're looking for a training data platform to label data for research that will one day need FDA approval, you can try V7 free or speak to our sales team.