SAFE Standard and Arcot Software Used By AstraZeneca to Submit First Digitally Signed Submission to FDA.Ushering in Noun 1. ushering in - the introduction of something new; "it signalled the ushering in of a new era" first appearance, introduction, debut, entry, launching, unveiling - the act of beginning something new; "they looked forward to the debut of their new product line" a New Era in the Drug Approval Process, Digital Workflow In print publishing, using the computer to lay out text and illustrations prior to creating film negatives for every page or going directly to plate. Prior to digital workflow, the typesetting and pre-press stages were far more time consuming and labor-intensive. Expected to Improve Time to Market SUNNYVALE, Calif. & NEW YORK New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of -- SAFE-BioPharma Association and Arcot Systems today announced that AstraZeneca, a major international healthcare business, has become the first company to send digitally-signed submissions to the 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. . AstraZeneca which is engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and is a supplier of healthcare services, has committed to the digital workflow process using the SAFE (Signatures and Authentication for Everyone Signatures and Authentication For Everyone (SAFE), is a set of enforced standards that create a trusted community for legally enforceable Business to Business and Business to Government digitally signed transactions within the global biopharmaceutical industry. ) digital identity and signature standard in combination with authentication software from Arcot Systems. Far beyond a facsimile or other electronic signature, the SAFE digital signature standard gives companies the ability to sign regulatory and commercial transactions in a tamperproof tam·per·proof adj. Designed to prevent tampering or provide evidence of tampering: tamperproof aspirin containers. and legally enforceable way. The submission is believed to be the first instance of a global pharmaceutical company doing end-to-end digital workflow, enabling a completely paperless process that is expected to result in bringing critical therapies to market more quickly than previously possible. Driven by market demand for efficiency and safety, the SAFE digital signature standard resulted from a need to provide a consistent and industry-wide method for managing and utilizing digital signatures. The standard was developed and is maintained by SAFE-BioPharma Association, a collaborative pharmaceutical industry initiative. The AstraZeneca approach marries the SAFE standard with Arcot's Universal Client, a single interface for deploying, managing, and validating digital certificates. This interface enhances end-user experience through a consistent look-and-feel, and provides access to various digital identity credentials - such as smart cards Example of widely used contactless smart cards are Hong Kong's Octopus card, Paris' Calypso/Navigo card and Lisbon' LisboaViva card, which predate the ISO/IEC 14443 standard. The following tables list smart cards used for public transportation and other electronic purse applications. and Arcot's own software smart card built on the company's "camouflage" technology. "Previously, the legal community lacked confidence in the legal staying power of an electronic document," stated 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 (www.safe-biopharma.org). "We gave them that confidence by building a framework combining strong, PKI-based digital certificates, a state-of-the-art digital signing solution, unique standards, and a closed-system rule set." "In using the digital signature in its submissions, AstraZeneca has clearly established itself as a leader in the movement to eliminate paper while maintaining the safety and security of the former manual approach," said Ram Varadarajan, president and CEO of Arcot. "Digital submission of drug trials is a breakthrough in a process that is tedious, yet which cannot be short-changed; the SAFE standard is well-named, and we are proud to be a participant." "This is a significant achievement for AstraZeneca," said Joe Waldron, Executive Director of US Drug Development Information Systems for AstraZeneca. "Digitally signed Any message or key that has been encrypted with a digital signature. When a user's public key is digitally signed by a certification authority (CA), it is known as a digital certificate or digital ID. See digital signature and digital certificate. submissions will result in time efficiencies for us and for the FDA, and allow for earlier access to AstraZeneca submissions by the FDA Review Division." Companies have been capturing data electronically for a long time. Until now, the roadblock to going paperless has been the lack of a tamperproof way to sign the document and manage the legal risk. There were three critical success factors in gaining legal acceptance: 1) validation that the transaction actually occurred, 2) verification that the document has not been tampered with, and 3) authenticity of the signature of the person that signed the document. Arcot Systems' Universal Client digital signing system, a multi-layered authentication and digital signature technology, was chosen by AstraZeneca to manage the most elusive of all the elements, the digital signature. The Universal Client uses SAFE certificates to validate, in a legally acceptable way, the fact that the signature is authentic. About the SAFE-BioPharma Association SAFE-BioPharma Association is the non-profit association that created and manages the SAFE digital identity and signature standard for the pharmaceutical and healthcare industries. Through the SAFE standard, the association promotes interoperability and integration among researchers, vendors, regulators, clinicians and other pharmaceutical and healthcare stakeholders Stakeholders All parties that have an interest, financial or otherwise, in a firm-stockholders, creditors, bondholders, employees, customers, management, the community, and the government. . The SAFE standard provides a secure, enforceable, and regulatory compliant way to verify the identities of parties involved in business-to-business and business-to-regulator electronic transactions. SAFE stands for "Signatures and Authentication For Everyone." The Association's founder-members include 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 , GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble, and Sanofi-Aventis. For more information, visit www.safe-biopharma.org. About Arcot Arcot Systems is a leading provider of risk-based authentication, strong authentication, digital signing, and secure e-payment solutions. The company makes online transactions safe for millions of customers by blocking fraud and protecting access. Arcot technology defends against internet threats including phishing, man-in-the-middle, and spyware. Its 100% software authentication solutions eliminate the need for hardware tokens and complex login processes providing customers with strong, PKI-based authentication with the simplicity of a username/password interface. Arcot offerings are compliant with U.S. and international standards including 3-D Secure, IdenTrust, SAFE and FFIEC FFIEC Federal Financial Institutions Examination Council Internet Banking Authentication recommendations. For more information, visit http://www.arcot.com. About AstraZeneca AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Dow Jones the best known of several U.S. indexes of movements in price on Wall Street. [Am. Hist.: Payton, 202] See : Finance Sustainability Index (Global) as well as the FTSE FTSE A company that specializes in index calculation. Although not part of a stock exchange, co-owners include the London Stock Exchange and the Financial Times. Notes: The FTSE is similar to Standard & Poor's in the United States. 4Good Index. For more information about AstraZeneca, please visit: www.astrazeneca-us.com. Trademark disclaimers: SAFE is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association. Arcot, Arcot WebFort and ArcotID are registered trademarks of Arcot Systems Inc. All other trademarks are the property of their respective owners, and are used for identification purposes only. |
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