SAFE BioPharma Compliance - Overview

The SAFE (Signatures and Authentication for Everyone) initiative in the bio-Pharmaceutical industry created a digital identity standard to allow companies to meet the Federal requirements for digitally signing electronic documents. 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 US Food and Drug Administration (FDA) agreed to accept digital signatures for drug approval submissions to their electronic gateway so that companies could realize significant time savings in the approval process.

A milestone in the industry was achieved when AstraZeneca using the SAFE standard and an Arcot signing solution, became 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 going forward.

A pharmaceutical company can significantly accelerate their go-to-market process and reduce drug development costs by digitally signing and electronically submitting clinical trials and other drug approval documents.

Arcot's strong authentication and digital signing technologies help you to implement the SAFE standards for digitally-signed electronic drug approval submissions to the FDA. Our approach marries the SAFE standard with Arcot's Universal Client and provides a single interface for deploying, managing, and validating digital certificates. With Arcot, you have complete flexibility to determine how you want to protect your users' credentials: ArcotID Software Smart Card, USB token, on the user's computer, or a hardware smart card. You can now enable digital signing in your extended network of partners, providers, investigators, and patients.

Arcot solutions for the Bio-Pharma industry

• Arcot WebFort combined with the ArcotID Software Smart Card is a 100% software, two-factor, strong authentication solution. It adds the strength of PKI to any login process while maintaining the simplicity of a username/password interface.
  
  
• Arcot RegFort, a component of WebFort, delivers a complete, web-based digital credential management application. It simplifies your administration of credential issuance by incorporating a variety of registration and issuance options, credential types, and interfaces. It consolidates numerous credential-issuing systems into a single, easy to manage system.
  
  
• Arcot SignFort delivers secure digital signatures for your users without the need for expensive smart cards or hardware tokens. It enables employees, business partners, and customers to apply digital signatures easily and securely from virtually any desktop.
  
  
• The Arcot Universal Client, an optional component of SignFort, is a single interface for deploying, managing, and validating digital certificates. It enhances and simplifies your users' experience through a consistent look-and-feel, hiding the complexity of behind-the-scenes credential management.