AstraZeneca Receives Award for Pioneering Use of SAFE-BioPharma Digital Signatures to Sign Electronic Submissions to FDA.FT. LEE, N.J. -- AstraZeneca Pharmaceuticals (AZ) has received Bio-IT World magazine's 2008 Best Practices Grand Prize for its pioneering use of SAFE-BioPharma[TM] digital signatures to sign electronic submissions made through the FDA's eSubmissions Gateway. Established in 2003, Bio-IT World's Best Practices Awards Program recognizes organizations for outstanding innovations and excellence in the use of technologies, practices, and novel business strategies that advance drug discovery, development, biomedical research Biomedical research (or experimental medicine), in general simply known as medical research, is the basic research or applied research conducted to aid the body of knowledge in the field of medicine. , and clinical trials. AstraZeneca first used the SAFE-BioPharma digital signature standard to sign an electronic FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. submission in September 2006. Since that time, by using SAFE-BioPharma digital signatures, AZ has submitted hundreds of submissions in a fully paperless process. This has eliminated many overhead activities to create, sign, store, and maintain paper originals and other forms of backup. As a result, AZ has improved cost and time efficiencies and given the FDA earlier access to the submission by the review division. These improvements have resulted in bringing critical therapies to market more quickly than previously possible. SAFE-BioPharma digital signatures are legally binding and help eliminate the need for paper-based business processes and paper backup copies A disk, tape or other machine readable copy of a data or program file. Making backup copies is a discipline most computer users learn the hard way-- after months of work is lost. See backup and LAN free backup. . Individuals who are credentialed cre·den·tial n. 1. That which entitles one to confidence, credit, or authority. 2. credentials Evidence or testimonials concerning one's right to credit, confidence, or authority: via processes compliant with the SAFE-BioPharma industry standard have had their identity verified in a strongly trusted manner. When they digitally "sign" documents using any of the approaches that are compliant with the standard, the identity of the signer is clearly verified and the integrity of the document is cryptographically cryp·tog·ra·phy n. 1. The process or skill of communicating in or deciphering secret writings or ciphers. 2. Secret writing. cryp guaranteed. "AstraZeneca is to be congratulated for receiving this award and for its leadership in taking the first steps toward fully paperless FDA submissions," said Mollie mollie or molly, New World fish of the genus Mollienesia, in the same family as the guppy (see killifish). Mollies are found from the E and central United States to Argentina. Shields-Uehling, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , SAFE-BioPharma Association. "The company is an example of the realization of the SAFE-BioPharma vision to catalyze cat·a·lyze v. To modify, especially to increase, the rate of a chemical reaction by catalysis. catalyze to cause or produce catalysis. the transformation of the biopharmaceutical and healthcare communities to a fully electronic business environment." In addition to this award, AstraZeneca won a Bio-IT World Best Practice award for standardizing screening data globally and making it available to all AstraZeneca sites. About SAFE-BioPharma Association SAFE-BioPharma Association is the non-profit association that created and manages the SAFE-BioPharma[TM] digital identity and signature standard for the pharmaceutical and healthcare industries. 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 The capability of two or more hardware devices or two or more software routines to work harmoniously together. For example, in an Ethernet network, display adapters, hubs, switches and routers from different vendors must conform to the Ethernet standard and interoperate with each other. 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 Amgen, AstraZeneca, Bristol-Myers Squibb Bristol-Myers Squibb (NYSE: BMY), colloquially referred to as BMS, is a pharmaceutical corporation, formed by a 1989 merger between pharmaceutical companies Bristol-Myers Company, founded in 1887 by William McLaren Bristol and John Ripley Myers in Clinton, NY (both were , Genzyme, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble, Roche and Sanofi-Aventis. For more information, visit www.safe-biopharma.org. SAFE-BioPharma[TM] is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association. |
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