Open Text Supports Pharmaceutical Industry's SAFE Initiative

Jun 11, 2004


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Open Text Corporation, a provider of enterprise content management (ECM) software, has announced its support for the Secure Access For Everyone (SAFE) initiative. SAFE was unveiled by a group of major biopharmaceutical companies, in cooperation with regulators and industry associations, in an effort to provide an open, global standard for secure and legally enforceable digitally signed edocuments 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.

The SAFE initiative will address the 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. SAFE intends to establish a digital identity standard that will help create a common, trusted infrastructure among 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 companies working in cooperation with regulators and industry associations, such as 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. Open Text will introduce and market a fully compliant Livelink solution for SAFE shortly after the SAFE certification process is in place.
(www.opentext.com; www.opentext.com/pharmaceutical/safe.html; www.safe-biopharma.org)