With TurboAC™, user can save a risk analysis report or assurance case into PDF files that can be printed onto paper, or export the assurance case into a graphic file that is viewable through a web browser. The graphic file comes with the capability for the reviewer to navigate and search within the assurance case report. The user can also export an entire risk management results into an encrypted electronic file and submit it to FDA with read-only permission. 


Users can export the reports in two modes:


a. Export the data for review purpose such as FDA reviewers (no editing allowed, but reviewer can add comments)


b. Export a RMF as a template for another similar product RMF to base on.


Regulatory Reviews


FDA has TurboAC™ installed in its lab, and is able to import and review electronic read only assurance case submissions. FDA can add/manage review comments within the agency. The electronic assurance case submission helps to expedite FDA’s review and approval.

Depending on manufacturer's preference, manufacturer can simply send the graphic assurance case file that reviewers can review using web browsers.