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Open Text to Support Pharmaceutical Industry’s "SAFE" Initiative, Among First to Provide Technology Prototype
Initiative Establishes Industry Standards for Secure Exchange of Critical Regulatory Documents Between Companies, and with Regulators
Chicago, IL. - 2004-06-09 - Open Text™ Corporation (Nasdaq: OTEX, TSX: OTC), the world’s largest provider of Enterprise Content Management (ECM) software, today announced its support for the Secure Access For Everyone (SAFE) initiative. SAFE was unveiled today by a group of major biopharmaceutical companies, in cooperation with regulators and industry associations, to provide an open, global standard for secure and legally enforceable digitally signed e-documents exchanged among biopharmaceutical companies and with their regulators. Open Text is among the first companies providing integrated technology for a prototype of the new system. Open Text announced the news just ahead of the 40th Annual Drug Information Association (DIA) General Meeting underway next week in Washington D.C.
The SAFE initiative will address the industry’s growing challenge of securely sharing massive, complex regulatory documents produced during research and development, and submitted to regulators to gain approvals on new drugs or medical devices. Companies must sometimes collaborate on joint regulatory submissions, as well as work closely with regulators over a period of years to gain approvals. Industry regulations make document security and integrity an absolute necessity. Without industry-wide standards for document signing and exchange, there is no easy, consistent way for biopharmaceutical companies to securely exchange documents and confirm their authenticity.
SAFE will establish a digital identity standard that will help create a common, trusted infrastructure between companies, partners and regulators. The SAFE model will allow pharmaceutical and life sciences organizations to meet the requirements for document authentication, legally binding digital signatures, integrity, uniform liability controls and privacy through the use of existing technology. SAFE includes some of the industry’s largest global companies working in cooperation with regulators and industry associations, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries Association (EFPIA).
Technology Prototype, Open Text’s Role
Open Text is taking part in a prototype of the SAFE system, providing integrated identity assurance, role-based access, XML forms, workflow and digital signatures as part of the Livelink software suite. Other companies involved in the prototype include Kyberpass, a provider of a server-side trust integration platform; and Arcot Systems, which provides a digital identity plug-in that performs the digital signature creation and validation, as well as document encryption functions. Also participating are Wells Fargo and The Royal Bank of Scotland, which are providing issuance and validation of digital identities.
“SAFE sets standards that eliminate many of the technical, proprietary and regulatory barriers to the collaboration that is so important in the development of new drugs and medical devices,” said Martin Sumner-Smith, Vice President of Pharmaceutical and Life Sciences Solutions at Open Text. “Organizations will be able to easily and securely exchange and verify key documents with partners and regulators. It will mean greater accountability and improved processes for regulatory compliance.”
Open Text will introduce and market a fully compliant Livelink solution for SAFE shortly after the SAFE certification process is in place. The solution will add to a growing list of biopharmaceutical industry solutions introduced by Open Text in the last few years to help companies manage compliance with industry standards and regulations worldwide. Others include Livelink for Clinicals, Livelink for Regulated Documents and Livelink for Collaborative Submissions. The company has also introduced solutions to meet industry standards for document integrity and security, including electronic and digital signatures and document e-notarization, all integrated with its industry applications.
Open Text will display working prototypes of the SAFE document management system at the DIA Annual General Meeting in Washington, D.C., June 13-17, 2004, at the Open Text booth, #1225. For further details on Open Text at DIA, go to http://www.opentext.com/events/event.html?id=35432. For more information on Open Text and SAFE, go to: http://www.opentext.com/pharmaceutical/safe.html or visit the SAFE website at http://www.safe-biopharma.org.
The SAFE initiative will address the industry’s growing challenge of securely sharing massive, complex regulatory documents produced during research and development, and submitted to regulators to gain approvals on new drugs or medical devices. Companies must sometimes collaborate on joint regulatory submissions, as well as work closely with regulators over a period of years to gain approvals. Industry regulations make document security and integrity an absolute necessity. Without industry-wide standards for document signing and exchange, there is no easy, consistent way for biopharmaceutical companies to securely exchange documents and confirm their authenticity.
SAFE will establish a digital identity standard that will help create a common, trusted infrastructure between companies, partners and regulators. The SAFE model will allow pharmaceutical and life sciences organizations to meet the requirements for document authentication, legally binding digital signatures, integrity, uniform liability controls and privacy through the use of existing technology. SAFE includes some of the industry’s largest global companies working in cooperation with regulators and industry associations, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMEA), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries Association (EFPIA).
Technology Prototype, Open Text’s Role
Open Text is taking part in a prototype of the SAFE system, providing integrated identity assurance, role-based access, XML forms, workflow and digital signatures as part of the Livelink software suite. Other companies involved in the prototype include Kyberpass, a provider of a server-side trust integration platform; and Arcot Systems, which provides a digital identity plug-in that performs the digital signature creation and validation, as well as document encryption functions. Also participating are Wells Fargo and The Royal Bank of Scotland, which are providing issuance and validation of digital identities.
“SAFE sets standards that eliminate many of the technical, proprietary and regulatory barriers to the collaboration that is so important in the development of new drugs and medical devices,” said Martin Sumner-Smith, Vice President of Pharmaceutical and Life Sciences Solutions at Open Text. “Organizations will be able to easily and securely exchange and verify key documents with partners and regulators. It will mean greater accountability and improved processes for regulatory compliance.”
Open Text will introduce and market a fully compliant Livelink solution for SAFE shortly after the SAFE certification process is in place. The solution will add to a growing list of biopharmaceutical industry solutions introduced by Open Text in the last few years to help companies manage compliance with industry standards and regulations worldwide. Others include Livelink for Clinicals, Livelink for Regulated Documents and Livelink for Collaborative Submissions. The company has also introduced solutions to meet industry standards for document integrity and security, including electronic and digital signatures and document e-notarization, all integrated with its industry applications.
Open Text will display working prototypes of the SAFE document management system at the DIA Annual General Meeting in Washington, D.C., June 13-17, 2004, at the Open Text booth, #1225. For further details on Open Text at DIA, go to http://www.opentext.com/events/event.html?id=35432. For more information on Open Text and SAFE, go to: http://www.opentext.com/pharmaceutical/safe.html or visit the SAFE website at http://www.safe-biopharma.org.
About Open Text
Open Text™ is the market leader in providing Enterprise Content Management (ECM) solutions that bring together people, processes and information in global organizations. Throughout its history, Open Text has matched its tradition of innovation with a track record of financial strength and growth. Today, the company supports more than 17 million seats across 13,000 deployments in 67 countries and 12 languages worldwide. For more information on Open Text, go to: www.opentext.com
Trademark
Copyright © 2004 by Open Text Corporation. LIVELINK and OPEN TEXT are trademarks or registered trademarks of Open Text Corporation in the United States of America, Canada, the European Union and/or other countries. This list of trademarks is not exhaustive. Other trademarks, registered trademarks, product names, company names, brands and service names mentioned herein are property of Open Text Corporation or other respective owners.
Release Disclaimer
This news release may contain forward-looking statements relating to the success of any of the Company’s strategic initiatives, the Company’s growth and profitability prospects, the benefits of the Company’s products to be realized by customers, the Company’s position in the market and future opportunities therein, the deployment of Livelink and our other products by customers, and future performance of Open Text Corporation. Forward-looking statements may also include, without limitation, any statement relating to future events, conditions or circumstances. Forward-looking statements in this release are not promises or guarantees and are subject to certain risks and uncertainties, and actual results may differ materially. These risks and uncertainties include, among others, risks involved in the completion and integration of acquisitions, the possibility of technical, logistical or planning issues in connection with deployments, the continuous commitment of the Company's customers and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission (SEC), including the Form 10-K for the year ended June 30, 2002, and Form 10-Q for the quarters ended March 31, 2003, June 30, 2003, September 30, 2003 and December 31, 2003. You should not place undue reliance upon any such forward-looking statements, which are based on management's beliefs and opinions at the time the statements are made, and the Company does not undertake any obligations to update forward-looking statements should circumstances or management's beliefs or opinions change.
For more information, please contact
Margaret E. Dobbin
Director, Industry Analyst Relations
Open Text Corporation
+1-519-888-7111 ext.2410
mdobbin@opentext.com
Director, Industry Analyst Relations
Open Text Corporation
+1-519-888-7111 ext.2410
mdobbin@opentext.com
