Frequently Asked Questions

What is the SAFE-BioPharma Association digital identity and signature standard?

The SAFE-BioPharma standard provides users with a secure, enforceable, and regulatory compliant way to verify identities of parties involved in electronic transactions and to apply their digital signatures to electronic documents. SAFE-BioPharma digital signatures are legally binding and help eliminate the need for paper-based business processes and paper backup copies. Individuals who are credentialed via processes compliant with the SAFE-BioPharma industry standard have had their identity verified in a strongly trusted manner. When they digitally “sign” documents using any of the approaches that are compliant with the standard, the identity of the signer is clearly verified and the integrity of the document is cryptographically guaranteed.

Why is the SAFE-BioPharma digital identity and signature standard needed?

The growing culture of collaboration within the pharmaceutical and healthcare industries requires working with a broad community of resources -- each constituting its own island of information. Standardizing the way identity is determined and how documents can be digitally signed is possibly the single most important change that will allow the many information islands to communicate efficiently and with trust. The SAFE-BioPharma digital identity and signature standard provides a secure, enforceable, and regulatory compliant way to verify the identities of parties involved in business-to-business and business-to-regulator electronic transactions.

How does the SAFE-BioPharma digital identity and signature standard facilitate interoperability?

The SAFE-BioPharma standard allows secure and trusted information exchange within a growing global network comprising many different entities with many different information systems. This network includes government agencies such as the FDA, Health and Human Services, Department of Defense, Homeland Security, US Patent and Trademark Office and others. SAFE-BioPharma is the first and only network of trust between the biopharmaceutical and healthcare industries and Federal agencies. The SAFE-BioPharma network includes a variety of SAFE-BioPharma member companies and commercial issuers including IdenTrust, Chosen Security, and Transsped.

What is the benefit of receiving credentials through SAFE-BioPharma compared to other credentialing service companies?

SAFE-BioPharma is a global, interoperable digital identity and signature standard for use across the biopharmaceutical and healthcare industries. Others, such as VeriSign, are individual vendors with specific product biases. As a standard, SAFE-BioPharma is technology and vendor neutral and avoids the complexity of dealing with multiple digital signatures across multiple trust networks. SAFE-BioPharma also works closely with regulatory agencies to ensure they understand and accept SAFE-BioPharma digital identities and signatures.

How is the SAFE-BioPharma digital identity and signature standard being used?

SAFE-BioPharma member companies are using the SAFE-BioPharma standard in ways that achieve numerous goals including streamlining processes, protecting intellectual property and reducing costs. The standard is a convenient way to apply legally binding digital signatures to electronic documents. The identity of the signer is clearly verified and the integrity of each digitally signed document is cryptographically guaranteed. SAFE-BioPharma digital signatures are being used to sign electronic laboratory notebooks, electronic regulatory submissions, contracts and a wide variety of forms. Member companies also use the SAFE-BioPharma standard for a variety of identity management functions including employee access, external partner authentication, etc.

How can the SAFE-BioPharma digital identity and signature standard benefit healthcare?

The growing culture of collaboration within the pharmaceutical and healthcare industries requires working with a broad community of resources -- each constituting its own island of information. Standardizing the way identity is determined and how documents can be digitally signed is possibly the single most important change that will allow the many information islands to communicate efficiently and with trust. The SAFE-BioPharma digital identity and signature standard provides a secure, enforceable, and regulatory compliant way to verify the identities of parties involved in business-to-business and business-to-regulator electronic transactions.

Do regulatory bodies recognize the SAFE-BioPharma digital identity and signature standard?

Yes. Electronic documents signed using SAFE-BioPharma digital signatures are accepted by the FDA. They also meet the highest legal equivalent of handwritten signatures for mutual recognition across the European Union and the European Economic Area. SAFE-BioPharma Members can use the SAFE-BioPharma digital signature for business and regulatory transactions across Europe with confidence that they meet the strict EU and Member State requirements for legal digital signatures.

How does the SAFE-BioPharma digital identity and signature standard improve business processes?

The SAFE-BioPharma standard speeds all approval processes, including contract-signing, with internal and external parties. In doing so, it helps eliminate paper-handling and paper-retention and the associated time, errors and costs. The SAFE-BioPharma standard also facilitates efficient auditing through electronic retrieval.

How does the SAFE-BioPharma digital identity and signature standard mitigate risk?

The SAFE-BioPharma standard mitigates risk on many levels. It is a secure, enforceable, and regulatory-compliant way to verify and manage internal and external identities of parties involved in electronic transactions. The SAFE-BioPharma standard also provides a convenient way to apply legally binding digital signatures to electronic documents. With each signature the identity of the signer is clearly verified and the integrity of document is cryptographically guaranteed. Regulatory agencies recognize and can audit the SAFE-BioPharma digital signature.

Its growing use in Electronic Laboratory Notebooks and other applications assures protection of intellectual property and strong evidence in legal proceedings around patent disputes.

SAFE-BioPharma members and users sign contracts recognizing the legal validity of the digital signature.  Should there be a dispute, SAFE-BioPharma rules require arbitration by the London Court of International Arbitration (instead of courts of law).

What is the SAFE-BioPharma Association?

SAFE-BioPharma Association is the non-profit association that created and manages the SAFE-BioPharma™ digital identity and signature standard for the pharmaceutical and healthcare industries. The SAFE-BioPharma industry standard is used to mitigate legal, regulatory and other business risk associated with business-to-business and business-to-regulator electronic transactions. SAFE-BioPharma’s vision is to be a catalyst in transforming the biopharmaceutical and healthcare communities to a fully electronic business environment by 2012. The Association’s members include Abbott, Alkermes, Allscripts, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Forest Laboratories, GlaxoSmithKline, Merck, Omnicare, Pfizer, Roche and Sanofi.

What is the SAFE-BioPharma RAS Privacy Policy?

The SAFE-BioPharma RAS Privacy Policy discloses the privacy practices for the SAFE-BioPharma Association (“SAFEBioPharma”) Registration Authority System (“RAS”) web site and describes:
(1) what personally identifiable information is collected;
(2) what organization is collecting the information;
(3) how the information is used
(4) how the information is disclosed to third parties;
(5) what choices are available to you regarding collection, use and distribution of the information;
(6) how to correct, update or delete personally identifiable information;
(7) how you can register complaints or file a dispute;
(8) what kind of security procedures are in place to protect the loss, misuse or alteration of information under the company’s control; and
(9) our compliance with US-EU Safe Harbor privacy principles

For a copy of the complete policy, click here.

The Industry Standard for Digital Trust!

Contact Details

  • Address:82 N. Summit Street, Suite 2
    Tenafly, New Jersey 07670

  • Phone: 903-471-1150

  • Email: info@safe-biopharma.org

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