FOR IMMEDIATE RELEASE Document Authentication Systems Announces E-Commerce Product in Full Compliance with FDA Regulations BALTIMORE, Maryland, October 16, 1998
– Document Authentication Systems, Inc. (DAS) announced today that they have developed an electronic process that will permit full compliance with the FDA's regulation on "Electronic Records; Electronic Signatures," 21 CFR Part 11.
"DocuGuard™ software accommodates all the critical functions that are necessary for an electronic document to be considered 'an original writing' in the context of many legal transactions,
permitting drug companies to submit applications electronically without an accompanying paper copy," said Douglas H. Trotter, chief executive officer for DAS. "DocuGuard™ software is the only
'off-the-shelf' product that alone is fully compliant with all requirements of the FDA's 21 CFR Part 11. In fact, the DocuGuard™ system goes far beyond FDA requirements by providing complete information
access control and security to a business organization." "There are many technologies available today that provide for the electronic exchange and review of regulatory information," said Trotter.
"However, if product development and marketing in the pharmaceutical industry is going to be on a global scale, the document management technology to handle this competitive environment must be robust; it
must be a system that permits the secure transfer, storage and retrieval of original, authenticated regulatory documents, clinical trial reports, patients' records, NDA submissions, and other vital
documents." "We believe Part 11 presents an opportunity to the pharmaceutical industry. Companies are now permitted to remove the paper barriers from their development and business processes, enabling
them to implement a paperless submission, processing, analysis, review, archiving, and dissemination process," said Trotter. "With DocuGuard™ software, they are enabled to make these changes and still
remain in full compliance with the FDA." Innovative and revolutionary, DocuGuard™software accelerates the drug development, manufacturing and distribution processes by providing a reduction in
process cycle time and integrating an electronic supply chain. The results are significant: a substantial reduction in the time it takes to get new drugs to the market, improved internal efficiencies,
reduced labor, better inventory control and a reduction in documentation cycle time. DAS has recently signed a letter-of-intent with Sterling Commerce to implement DocuGuard™ software in the
pharmaceutical arena to relieve the burden of this industry's many paper-intensive regulatory requirements. Other DAS partners and customers include: Arkoma Venture Partners, General Electric Capital
Corporation, Perot Systems Corporation, Prime New Ventures, Renaissance Capital Group, Seed Capital Partners and Xcert International, Inc. About Document Authentication Systems, Inc.
Established
in 1996, DAS is located in Baltimore, Maryland, with offices in Danbury, Connecticut, and Columbus, Ohio. Document Authentication Systems, Inc. develops and markets an enterprise application solution for the
electronic commerce market space under the name DocuGuard™. DocuGuard™ enables the creation of the "Electronic Original™." It is the essential piece and the missing link of true
business-to-business electronic commerce allowing business transactions to be conducted over a VAN or the Internet. --end--
DocuGuard™ and Electronic Original™ are trademarks of e-Original, Inc. |
