Overview[1]#

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

More Information#

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« This page (revision-3) was last changed on 22-Aug-2015 09:58 by jim