Regulatory Compliance

PeakInvestigator™ is designed to be 21 CFR Part 11 and HIPAA compliant upon commercial release. It transfers raw spectra and spectral peak lists to and from the Veritomyx servers through the PeakInvestigator API and connections using encrypted SSH/SFTP/HTTPS protocols. It tags and transfers all scan data using code names applied by the API on the client machine, after removing any patient-specific information.

PeakInvestigator utilizes embedded checksums with all files to ensure completeness and error-free file transfers. It adds comments to each output file to trace the name of the associated input file, creation date and time stamps, software versioning, operating system image numbering, and specific parameter settings used in the processing so that any run can be replicated in the future. Veritomyx servers automatically erase all customer files after they are retrieved by the client-side software.

We utilize large compute clusters world-wide, increasing and decreasing our dedicated compute nodes on those clusters to meet customer demand. We establish our own operating system image, regression test each new node added and maintain time and date-stamped quality assurance logs of the hardware utilized.