The SAFE-BioPharma Association® Bridge Certificate Authority is part of a growing network of trust permitting government agencies and other entities to trust the origins of electronic documents from within the network.
In April 2008 SAFE-BioPharma went “live” with the Federal Bridge Certificate Authority (FBCA). This allows people responsible for a broad range of functions within the pharmaceutical and healthcare industries to exchange information securely with government agencies and with the growing number of other entities that have linked through the FBCA.
FBCA participants include Health and Human Services, the Food and Drug Administration, Homeland Security, and the US Patent and Trademark Office.
While potential uses are wide-ranging, those currently in use or under consideration include the following:
- Signing submissions made through the FDA’s eSubmissions Gateway (AstraZeneca)
- Submitting a broad range of regulatory documents
- Signing NIH grants
- Managing contracts with the Veterans Administration
- Submitting documents to Homeland Security associated with managing biological threats
To date FDA inspectors have received training to recognize electronic documents signed with SAFE-BioPharma digital signatures. SAFE-BioPharma plans to initiate educational programs that will acquaint personnel within other Federal agencies with SAFE-BioPharma digital signatures.
SAFE-BIOPHARMA ISSUERS REQUIRE CROSS-CERTIFICATION WITH SAFE-BIOPHARMA BRIDGE CERTIFICATE AUTHORITY
Organizations seeking to provide authentication and digital signature services and to become issuers of SAFE-BioPharma credentials must first cross-certify with the SAFE-BioPharma Bridge Certificate Authority (SBCA).
Currently, Bristol-Myers Squibb, Citibank, CyberTrust, Exostar , Johnson & Johnson, and TransSped are cross-certified with SBCA.
Parties interested in cross-certifying with SBCA are encouraged to contact Jon Schoonmaker, SAFE-BioPharma’s Chief, Technical Programs and Operations Officer at Jon.schoonmaker@safe-biopharma.org.
