CIMdata PLM Industry Summary Online Archive
9 June 2004
Company News
Open Text to Support Pharmaceutical Industry's "SAFE" Initiative, Among First to Provide Technology Prototype
Open TextT Corporation 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).
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
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