AstraZeneca Using SAFE

SAFE standard and Arcot Software used by AstraZeneca to submit first digitally signed submission to FDA

SUNNYVALE, Calif. -- SAFE-BioPharma Association and Arcot Systems today announced that AstraZeneca, a major international healthcare business, has become the first company to send digitally-signed submissions to the FDA. AstraZeneca which is engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and is a supplier of healthcare services, has committed to the digital workflow process using the SAFE (Signatures and Authentication for Everyone) digital identity and signature standard in combination with authentication software from Arcot Systems.

Far beyond a facsimile or other electronic signature, the SAFE digital signature standard gives companies the ability to sign regulatory and commercial transactions in a tamperproof and legally enforceable way. The submission is believed to be the first instance of a global pharmaceutical company doing end-to-end digital workflow, enabling a completely paperless process that is expected to result in bringing critical therapies to market more quickly than previously possible.

Arcot Systems

Editors' Choice
Elizabeth Montalbano, Contributor, Dark Reading
Nate Nelson, Contributing Writer, Dark Reading
Nate Nelson, Contributing Writer, Dark Reading