In 2003, SAFE-Biopharma, LLC a non-profit association of pharmaceutical companies was formed with the mission to create and manage a worldwide electronic signature standard. SAFE, an acronym for Secure Access For Everyone is a set of legal, business and technical policy standards that provide strong identity authentication and legally enforceable digital signatures for Business-to-Business and Business-to-Government transactions within the global biopharmaceutical industry.

CSI has experience design and deployment of a SAFE process with a major pharmaceutical company:

  • expertise for quality management of projects necessary for integrating business processes within a SAFE initiative to provide legally enforceable electronic signatures to regulatory documents.
  • guidance on interpretation of the SAFE standards for application in process design and validation of identity and digital signature systems.
  • implementation of SAFE–enabled applications and software within a compliant environment.