Identity credentials based on the SAFE-BioPharma standard are trusted by a growing network of US, EU and EU Member State government agencies, in academia, and by entities in the pharmaceutical and other industries. This trust allows for the secure Internet exchange of informaion.
Current and potential uses include:
- Signing submissions made through the FDA’s eSubmissions Gateway
- Exchanging, reviewing and signing cloud based documents between industry and government researchers.
- Submitting regulatory documents (EMA now requires digital signatures)
- Signing NIH grant applications
- Managing contracts with VA, other agencies
- Submitting documents to Homeland Security associated with managing biological threats
FDA inspectors are trained to recognize electronic documents signed with SAFE-BioPharma digital signatures. Personnel in other agencies will be educated about SAFE-BioPharma digital signatures.
Organizations seeking to provide authentication and digital signature services and/or become issuers of credentials that conform to the SAFE-BioPharma standard must first cross-certify with the SAFE-BioPharma Bridge Certificate Authority (SBCA).
Currently, Exostar (US and EU QCA), Zentry (US and EU QCA) and Trans Sped Mobile QCA are cross-certified with SBCA.
To cross-certify with SBCA, contact David Simonetti (email@example.com), Policy and Governance Manager, SAFE-BioPharma Association.