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
(http://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 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
http://www.safe-biopharma.org.
