|This article relies on references to primary sources. (February 2010)|
SAFE-BioPharma Association is the non-profit association that created and manages the SAFE-BioPharma digital identity and digital signature standard for the global pharmaceutical, biotech and healthcare industries. SAFE stands for "Signatures & Authentication For Everyone" (but originally stood for "Secure Access For Everyone"). It was originally created as an initiative of the Pharmaceutical Research and Manufacturers of America (PhRMA) association to encourage the use of a common digital identity and digital signature standard for the pharmaceutical industry, but is now an independent non-profit association offering such standards services to the government and the entire healthcare industry.
The SAFE-BioPharma industry standard is used to establish and manage digital identities and to issue and apply digital signatures. It mitigates legal, regulatory and business risk associated with business-to-business and business-to-regulator electronic transactions. It also facilitates interoperability by providing a secure, enforceable, and regulatory-compliant way to verify identities of parties involved in 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 SAFE-BioPharma digital identity and signature standard operates one of the nation’s leading Public Key Infrastructure (PKI) Certification Authority Bridges. These PKI certificate bridges establish an infrastructure for the trusted exchange of confidential information and the reliable authentication of identities over the Internet. By providing a highly secure way to validate, trust, and manage identities of unknown participants in an Internet transaction, the SAFE-BioPharma Bridge Certificate Authority (SBCA) is essential to helping achieve the speed, efficiency and cost-savings inherent in use of the Internet for business transactions. This technology also improves interoperability across many different systems.
The SAFE-BioPharma Bridge Certificate Authority is cross-certified with the Federal Bridge Public Key Infrastructure Architecture (FPKIA), facilitating the ability of SAFE-BioPharma member companies that meet certain security, technical and operational criteria to leverage the identity credentials of any and all bridge members in the exchange of sensitive and confidential information. In essence, it allows officials in Health and Human Services, the Food and Drug Administration, Department of Defense, and other government agencies to trust the origins of electronic documents received from corporate managers, physicians, clinical researchers, etc. who are credentialed to digitally sign documents with SAFE-BioPharma digital signatures. Additionally, the identities are trusted for authentication access control for sites requiring strong authentication.
SAFE-BioPharma has worked closely with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other global healthcare and regulatory agencies to ensure the digital signatures generated using SAFE-BioPharma certificates meet regulatory requirements and are accepted by these agencies when used on documents that are part of electronic submissions. It thus allows voluminous paper documents used for regulatory compliance to be digitally signed and submitted in electronic form. This improves accuracy, reduces costs, enables electronic search and retrieval and saves energy and natural resources.
SAFE-BioPharma Association members include Abbott Laboratories (NYSE: ABT), Amgen (NASDAQ: AMGN), AstraZeneca (NYSE: AZN), Bristol-Myers Squibb (NYSE:BMY), GlaxoSmithKline (NYSE: GSK), Johnson & Johnson (NYSE: JNJ), Eli Lilly (NYSE: LLY), Merck (NYSE:MRK), National Notary Association, Pfizer (NYSE: PFE), Premier Inc., and Sanofi-Aventis (NYSE:SNY).
SAFE-BioPharma is a trademark of the SAFE-BioPharma Association. Any use of this trademark requires approval from the SAFE-BioPharma Association.
- Electronic lab notebook
- Title 21 CFR Part 11
- Digital signature
- Electronic Signatures in Global and National Commerce Act (ESIGN, USA)
- European Medicines Agency (EMEA)
- Food and Drug Administration (FDA)
- Pharmaceutical company
- Japan Pharmaceutical Manufacturers Association (JPMA)
- 21 CFR 11
- Digital signature
- Data management