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Case Study: Pharmaceutical Industry Association

Digital signatures for the pharmaceutical industry

Used with the permission of
Now Communications and FBC Media

SAFE-BioPharma Association is a global identity management coalition founded by AstraZeneca, Bristol- Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble, and Sanofi-Aventis.

SAFE (Signatures and Authentication for Everyone) delivers standardized identity credentials that can be used for authentication and electronic signing by the biopharmaceutical and healthcare providers that are members of the SAFE community. These credentials are legally enforceable and comply with industry regulations.

Cost savings from the removal of redundant identity credentials in the biopharmaceutical industry have been conservatively estimated by SAFE to be more than $200 million per year. Current thinking within the industry is that use of digital signatures could help reduce the industry’s reliance on paper, estimated at costing the biopharmaceutical industry over $9 billion a year and the health care industry about $500 billion a year.

The SAFE standard is recognized by the Food and Drug Administration (FDA) and the National Cancer Institute (NCI) as meeting federal requirements for Level III authentication and signatures and as being legally enforceable. The European Medicines Agency (EMEA) has evaluated SAFE as meeting all pertinent requirements for EU qualified digital signatures. The SAFE system is designed to assure the identities of its subscribers and to reduce risks affiliated with creating legally-enforceable digital signatures. According to the association, use of the SAFE credential will allow members to save more than $100 per user per year - a cost reduction of at least 38 percent - in their identity management activities for both internal and external business partners. SAFE is an alternative to multiple and incompatible identity management schemes established by a variety of companies.

The SAFE digital identity comprises policies, procedures, guidelines, technical specifications, and a legal and liability risk management framework. It is being implemented globally for members, and is being extended to members’ partners and research organizations in the Americas and Europe.

SAFE-BioPharma Association is encouraging the development of SAFE-enabled software and applications for a wide range of uses within the pharmaceutical and healthcare industries.

The CoreStreet Validation Authority software provides a secure, scalable and cost-effective way for participating organizations to trust every digitally-signed email message and document as well as applications shared with other members. CoreStreet software also makes it possible to instantly revoke an individual’s access rights, even if they are not connected to the network at that moment.

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