Market Demand for Standards-based Electronic Signatures in Document Management Systems Skyrockets

AIIM, Boston, MA 18 April, 2007

On the ten-year anniversary of the FDA issuance of the final rule for 21 CFR Part 11 for Electronic Records, EDM vendors worldwide are lining up to support the adoption of standards-based electronic signatures (digital signatures) within their solutions. This meets the growing demand for Enterprise Content Management (ECM) vendors to support standards-based electronic signatures for life science, Healthcare, Government, Finance and other industries.

Life Science organizations have driven standards-based Public Key Infrastructure (PKI) electronic signatures from a concept, to a trend, and now to an industry best practice for 21 CFR Part 11 compliance, and other regulations. Standards-based signatures on documents or database transactions eliminate the need for closed and costly proprietary electronic record systems that have burdened business processes between departments, applications and companies for years. 

Leading ECM vendors and partners now supporting CoSign® include Oracle®, IBM/FileNet®, OpenText’s Hummingbird®, Laserfiche®, Xerox®, DocuWare®, Microsoft®, and others who have already integrated their systems with the ARX CoSign solution on live implementations and as a standard solution offering.

"Oracle’s customers are now looking to utilize electronic and digital signatures for user authenticity, business process control for financial transactions, and for ensuring electronic pedigree authenticity. Companies are moving beyond electronic recordkeeping just for compliance, and understand the business benefits of improved collaboration, reduced risk and the enforcement of best practices that digital signature technology enables," said John Danese, Life Sciences ERP Product Director at Oracle.

"The bulk of 21 CFR Part 11 compliant document management and workflow systems deployed over the past decade have used a signature component that has been proprietary in nature, and the result is electronic record legacy systems that are painful to maintain," said John Marchioni, Vice President of Business Development, Americas, for  ARX, Inc. "It’s very clear the tide is turning, with life science companies requiring standards-based electronic signatures to create signed documents that become self-contained, portable electronic records, providing a tremendous return on investment for these organizations."

CoSign, ARX’s electronic signature solution, is leading the wave of electronic signature adoption with an appliance offering that greatly reduces the cost and complexity of traditional signature deployments. "The growth of CoSign’s use is quite remarkable. Our healthcare and life sciences client base has increased over 1000% in the past two years alone," said Marchioni. "CoSign has driven the Total Cost of Ownership of electronic signature deployments down to 10-15% of traditional PKI deployments in years past. And the server-based architecture, combined with ARX’s  extensive application support, drives rapid deployment and user adoption."

"We determined standard PKI-based electronic signatures were the most secure and widely accepted solution for regulatory compliance," said Zikria Syed, CEO of NextDocs – a Microsoft MOSS 2007 Launch Partner.

"CoSign combined with Xerox DocuShare™ and the Sitrof® Compliance Module enables life science organizations to optimize document approval workflows and create electronic records that are self-sustained inside the clients’ organization," said Dan Wheeler, President, Sitrof Technologies, Inc.

"We have seen a growing customer demand for electronic signature solutions initiated both by legislation requirements as well as the need to save on time and costs related to printing, signing and mailing documents," said Tony Heywood, Senior VP EMEA, OpenText ECM (formerly Hummingbird). Hummingbird customer, EFTA (European Free Trade Association) Surveillance Authority, uses CoSign to work with their Hummingbird document management system, doing away with the need for printing, signing and mailing documents, simply for signing purposes.

"CoSign’s capabilities for protecting the integrity of electronic signatures and documents complements Laserfiche’s extensive built-in security features, making ARX a valuable addition to the Laserfiche PDP program," said Hedy Aref, Vice President of Vertical Marketing at Laserfiche.

Ron Janssen, Marketing Director of Square DMS (IBM/FileNet VAR) stated CoSign is "a solution that will enable our customers a smooth migration to electronic signatures and a total paperless environment. CoSign offers our customers a unique integration with their own existing corporate environment that is very simple to use and deploy."

The benefits of CoSign go well beyond 21 CFR Part 11 compliance, enabling life science organizations to eliminate the tremendous costs and time of securing approvals. Industry averages place this human and hard cost at a minimum of $10-20 per document. Furthermore, electronically signed documents do not require any proprietary technology or licenses for recipients to validate authenticity or data integrity.  Hence, workflows and electronic submissions are extended beyond the traditional corporate, geographic, and technologic barriers of any single entity to include the extended network of partners collaborating on research, clinical development, regulatory approval and commercial activities.