21 CFR, Part 11 has to do with how systems handle electronic records/signatures. The stipulations of this rule that apply to iSalus are often in relation to our assurances of an audit trail, the capture and storage of electronic signatures, data security, records retention, etc….
While iSalus has never been formally certified as a 21 CFR compliant system, our application is legally certified by the ONC as a CEHRT product. The ONC testing and certification process specifically addresses these various processes. You can view this certification here: https://chpl.healthit.gov/#/listing/10204.
