AstraZeneca Becomes First to Send Digitally Signed Submissions to FDA

This just in from the Safe Biopharma organization. (For an article that we'd published on that group written by Pfizer Senior Counsel Owen Hughes, click here). 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. 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) 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 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 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 Shields-Uehling, president and CEO SAFE-BioPharma Association ( "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 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. 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, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble, and Sanofi-Aventis. For more information, visit