News

Posted On: 09/13/2007

New Program Allows SAFE-BioPharma Vendor Partners to Assert Product Compliance

PharmaManufacturing.com

SAFE-BioPharma Association, which manages the SAFE digital identity and signature standard, on Sep. 12 announced a new program allowing SAFE Vendor Partners to self-test software and hardware products for compliance with the SAFE standard.

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. It is used by many of the world's largest pharmaceutical companies, which comprise the membership of SAFE-BioPharma.

Under guidance from SAFE's Chief Compliance Officer and using the SAFE functional and technical specification requirements as guidelines, Vendor Partners participating in the new SAFE Product Certification Program develop and execute test scripts to evaluate the compliance of their products. Results are then submitted to SAFE, where they are reviewed and, if compliant, approved as certified products.

"The newly revised SAFE Product Certification Program provides SAFE Member companies with the assurance that software and hardware products conform to the SAFE standard. It does this more efficiently and economically than in the past," said Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association. The new product certification program replaces a system in which a third-party provided testing services.

The SAFE Product Certification Program can be used to test any SAFE-enabled application, hardware token, OCSP responder, or hardware security module. The process will significantly reduce the time required to complete certification. Reduced fees cover costs of required SAFE staff support.

SAFE Vendor Partners whose tested products conform to the SAFE standard will be allowed to indicate that their products have been certified by SAFE-BioPharma Association.

About SAFE-BioPharma Association

SAFE-BioPharma Association is the non-profit association that created and manages the SAFE(TM) digital identity and digital 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 members include Amgen, AstraZeneca, Bristol-Myers Squibb, Genzyme, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Procter & Gamble, Roche and Sanofi-Aventis. For more information visit www.safe-biopharma.org.