ARX CoSign is now Compliant with FDA's Electronic Submissions Gateway

ARX has reportedly announced that any document signed with the CoSign digital signature solution can now be electronically submitted to the U.S. Food and Drug Administration through its Electronic Submissions Gateway (News - Alert). ARX has announced that this facility is based on the FDA's Electronic Submissions Gateway User Guide issued in July.

 

The FDA ESG is the central transmission point for sending information electronically to the FDA. It facilities the secure submission of regulatory information for review and acts as a conduit along which submissions travel to reach their final destination. It also automatically routes the submissions to the proper FDA center or office.

 

CoSign is a the most widely-deployed digital signature (standard electronic signature) solution in FDA-regulated markets With advantages such as the reduction of employee time, as well as an elimination of the hard costs of routing, signing, and managing paper-based approvals, the customers of CoSign have seen a typical Return On Investment payback in two to three months, ARX said.

 

“By extending the benefits to regulatory operations for electronic FDA submissions, CoSign provides a comprehensive benefit throughout the entire lifecycle and ecosystem of controlled documentation,” Rodd Schlerf, life sciences market manager, ARX, said in a statement.

 

CoSign provides a comprehensive benefit throughout the entire lifecycle and ecosystem of controlled documentation by extending the benefits to regulatory operations for electronic FDA submissions. Offering a low Total Cost of Ownership for companies of all sizes, CoSign eliminates the cost and complexity of traditional PKI standards-based digital signature deployments.

 

The company recently created a joint solution with I.E. Mittwoch & Sons–NCR,  a leading provider of peripheral equipment and software, allowing an Israeli banking committee to actualize a nationally mandated security procedure for the clearing process of all digital check imagery. This solution allows the banks to digitally route thousands of checks a day.