INDUSTRY EXECUTIVE SAYS ENVIRONMENT RAPIDLY IMPROVING FOR PHARMACEUTICAL INDUSTRY USE OF DIGITAL SIGNATURES

FT. LEE, NJ (MARCH 8, 2007) -- The adoption and use of SAFE™ digital signatures throughout the pharmaceutical industry is improving exponentially, according to SAFE-BioPharma Association, the non-profit association that developed and manages the SAFE digital identity and digital signature standard

Some major pharmaceutical companies are using SAFE digital signatures to make FDA submissions, and numerous others are engaged in pilot projects.

The SAFE standard provides a secure, legally enforceable, and regulatory compliant way to verify the identities of parties involved in business-to-business and business-to-regulator electronic transactions. Through the SAFE standard, SAFE-BioPharma promotes interoperability and integration among researchers, vendors, regulators, clinicians and other pharmaceutical and healthcare stakeholders.

“The pharmaceutical industry is reaching a tipping point in its use of the SAFE digital identity and digital signature standard. The standard is being used to sign FDA submissions and for other applications. Additionally, numerous pilot projects are underway, and several major software and applications companies are enabling their products to support use of SAFE digital signatures,” said Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association.

Recent industry developments that underscore increased use of SAFE digital signatures include the following:

• Astra-Zeneca became the first pharmaceutical company to submit its required drug-reporting documents electronically to the U.S. Food and Drug Administration through the Agency’s Electronic Submissions Gateway (ESG) using SAFE digital signatures. In the several months since implementing SAFE signatures, the company reports successful submission of over 150 drug-safety and other digitally-signed documents to the FDA (2252, 356h, 1571, eCTD). The digital signings were accomplished utilizing Arcot’s Universal Client.
• Adobe Systems announced that three of its software products – Adobe Acrobat, Adobe Reader with Adobe LiveCycle Reader Extensions and Adobe LiveCycle Document Security – were the first products to be certified to comply with the SAFE digital signature standard.
• Microsoft announced that Microsoft Office 2007 contains a SAFE signing interface that will allow use of SAFE certificates to digitally sign documents from within the Microsoft Office system. In the past, only pdf documents could be signed using SAFE digital signatures.
• Procter & Gamble disclosed it is using the SAFE digital signature standard in its Electronic Laboratory Notebook (ELN) project which will be deployed to as many as 4,500 scientists and technologists inside the company. Additionally, P&G intellectual property lawyers have accepted SAFE digital signatures as the equivalent of wet signatures.  
• Johnson & Johnson Services, Inc. cross-certified with the SAFE bridge, both demonstrating compliance with the SAFE standard and assuring a known level of interoperability and trust for members of SAFE-BioPharma Association.

Additional projects by other major pharmaceutical companies include:

• Placement of more than 22,000 SAFE digital signatures on 14,000+ documents, covering both eLabNotebooks and regulatory filings.
• An eSampling pilot in which physicians order samples using the SAFE digital identity and signature, thus permitting a significant reduction in the time between placement of an order and receipt of samples.

SAFE-BioPharma Association’s founder-members include AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble, and Sanofi-Aventis. In addition to Adobe and Microsoft, companies participating in the SAFE Vendor Partner program include IBM, Arcot, BearingPoint, OpenText, CoreStreet, datalabs, IDBS, IdenTrust, Aladdin, Cybertrust, Hitachi, Algorithmic Research (ARX), Northrop Grumman, PA Consulting Group, SAIC, Solabs, SupplyScape, and SureScripts.

For more information about SAFE-BioPharma Association visit www.safe-biopharma.org.

SAFE™ is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association.