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SURVEY REPORTS INCREASING USE OF SAFE-BIOPHARMA DIGITAL STANDARD FT. LEE, NJ (JUNE 18, 2009) — More than 20 global pharmaceutical companies, regulatory agencies, and research and group purchasing organizations are using the SAFE-BioPharma (www.safe-biopharma.org) digital standard for digitally signing electronic documents and/or managing digital identities, according to a periodic survey conducted by the standard’s organizing body. According to non-profit SAFE-BioPharma Association, the SAFE-BioPharma standard is being used across the industry to improve business and research processes. These uses include digital signing of legal and regulatory documents and managing identities within and outside of SAFE-BioPharma’s member organizations. “SAFE-BioPharma digital signatures have the unique advantage of being recognized by regulatory bodies such as the FDA and EMEA and of being legally enforceable,” explained Mollie Shields-Uehling, the association’s president and CEO. When SAFE-BioPharma digital signatures are used to sign an electronic document there is no need to create and store a separate copy on paper or any other medium. Currently, SAFE-BioPharma digital signatures are used by researchers to sign electronic laboratory notebooks and other research and development documents, by regulatory affairs personnel to sign documents sent to the FDA’s eSubmissions Gateway, by marketing departments to sign review of promotional and other materials and by group purchasing agents to sign contracts. “Operations become more efficient when documents are signed digitally. The need for back up copies decreases. The cost of sending documents is eliminated. And the time and cost of document retrieval is reduced,” Ms. Shields-Uehling explained. The SAFE-BioPharma digital standard also is used extensively for identity management, with several biopharmaceutical companies relying on the standard to manage internal identities and those of their external partners. Because the standard is linked to the Federal Bridge PKI Architecture, a SAFE-BioPharma digital identity can be trusted by any Federal agency. SAFE-BioPharma is a part of the 4BF (www.the4BF.com), the group of identity trust federations encompassing the biopharmaceutical and healthcare industries, federal agencies, the aerospace and defense industries and the higher education sector in the US. The survey is conducted to track new and ongoing applications and uses of the SAFE-BioPharma standard. With few exceptions, survey details are confidential. #### About SAFE-BioPharma Association (www.safe-biopharma.org) The SAFE-BioPharma industry standard is used to mitigate legal, regulatory and other business risk associated with business-to-business and business-to-regulator electronic transactions. It facilitates interoperability by providing a secure, enforceable, and regulatory-compliant way to verify identities of parties involved in electronic transactions. SAFE-BioPharma’s vision is to be a catalyst in transforming the biopharmaceutical and healthcare communities to a fully electronic business environment by 2012. The Association’s members include:
SAFE-BioPharma™ is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from
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© 2008 SAFE BioPharma Association. All rights reserved. |
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