The SAFE-BioPharma® Digital Identity and Signature Standard was started by the biopharmaceutical industry to speed its transformation to a fully electronic environment. It is the sole global identity and signature standard serving the needs of the biopharmaceutical industry.
Every SAFE-BioPharma digital identity is uniquely linked to the subscriber’s proven identity.
Using the SAFE-BioPharma standard...
- provides interoperability with federal agencies, other companies and other industries
- provides a secure, enforceable, and regulatory-compliant way to verify digital identities and to apply digital signatures in electronic transactions. Compliant with EU/EMA requirements for digital signatures.
- greens the pharmaceutical and healthcare industries by eliminating hidden waste associated with paper
- improves business processes
- is 21CFR Part 11 compliant
- meets US Department of Commerce and EU SAFE Harbor requirements for protection of personal data
- mitigates legal, regulatory and other business risk associated with electronic transactions
SAFE-BioPharma digital signatures are more secure and useful than simple electronic signatures…
- ensure a single, unique identity is tightly bound to the digital signature
- provide document integrity – any change in the document invalidates the signature
- include contract-based legal framework for global legal enforceability
- recognized by FDA and EMA
- legally enforceable, non-repudiable, instantly auditable
- create a permanent record of the date and time the signature was applied
- valid for the life of the document
- compatible with electronic workflows