Digital Signatures on their Way to the FDA's ESG (Electronic Submission Gateway)

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Organizations using ARX's CoSign®, the leading digital signature solution in the FDA-regulated marketplace, can utilize the digital signature solution to submit electronic records to the FDA, reducing submission time and costs.

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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.

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.

About CoSign Digital Signatures
ARX's CoSign digital signature solution automates approvals affordably in a compliant manner, allowing organizations to go paperless, expedite business processes and save costs. CoSign is the only digital signature solution that is seamlessly integrated with Microsoft SharePoint and other popular DM/ECM solutions. CoSign signatures are globally accepted by external partners without the need for proprietary-validation software. CoSign is also centrally managed through the organization's user directory for reliable control of signature privileges, and ease of use and administration. Learn more about CoSign digital signatures.

About The Digital Signature Company - ARX
ARX (Algorithmic Research) is a global provider of cost-efficient digital signature solutions for industries such as life sciences, healthcare, government, and engineering. ARX engineers and scientists have more than 20 years of experience in security and standard digital signature application. ARX helps businesses secure, streamline, and scale their business processes and transactions with the proper controls required by legislation, regulation, and industry best practice. Visit us at http://www.arx.com.

CoSign is a registered trademark and CoSign PSF is a trademark of Algorithmic Research, Ltd. All other trade names and trademarks are the property of their respective holders.

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Michael Wikoff
ARX, Inc.
(415) 839 8161
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