San Francisco, California August 4, 2009
ARX Inc., the supplier of CoSign, the most widely-deployed digital signature (standard electronic signature) solution in the US Food and Drug Administration (FDA)-regulated markets, announced today that based on the FDA's Electronic Submissions Gateway (ESG) User Guide issued in July, any document signed with the CoSign digital signature solution can be electronically submitted to the FDA via the Electronic Submissions Gateway – the central transmission point for sending electronic information to the FDA.
In sample business cases the FDA estimates that electronic submissions, such as those utilizing a signing solution like CoSign, cost 30% less than paper and other traditional media submissions. These financial benefits are in addition to the daily benefits CoSign delivers throughout an organization's internal workflows, operations, and external collaborative business processes.
"Using CoSign our clients have seen a typical Return On Investment payback in 2-3 months, through the reduction of employee time, as well as an elimination of the hard costs of routing, signing, and managing paper-based approvals," explained Rodd Schlerf, Life Sciences Market Manager, ARX. "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."
The FDA’s General Counsel (GC) requires that the FDA must be able to determine the origin of a submission in order to implement fully electronic submissions through the use of X.509 certificates and public/private key exchange; this is provided by PKI-based digital signatures and ID certificates. CoSign eliminates the cost and complexity of traditional PKI standards-based digital signature deployments, providing a low Total Cost of Ownership for companies of all sizes. This is evidenced by the fact that CoSign is used by hundreds of large pharma, medical device, and Clinical Research Organizations (CROs), and still affordable enough to be used by thousands of individual investigator sites, IRBs, and labs.
Current or prospective CoSign users should contact ARX to find out how to inform the FDA that they will be using CoSign for electronic submissions via the Electronic Submissions Gateway.
