In late 2003, a number of pharmaceutical companies came together to discuss the need for creating an industry-wide global standard for digital identities. With the industry finally getting serious about reducing costly paper-based processes in favor of electronic information exchange, trustworthy digital signatures emerged as a necessary component. By 2005, a coalition of 13 companies had hammered out operating policies, legal structure, and the technical specifications for a highly secure trust environment that would eventually define Version 1.0 of a paperless standard and led to the formation of the SAFE-BioPharma Association, a not-for-profit organization.
President and CEO Mollie Shields Uehling says that the standard, now in Version 2.1, allows member companies to operate much more efficiently by eliminating the costs and time linked to creating, printing, signing, storing and maintaining paper originals. “Costs associated with paper are estimated at 40 percent of the cost of R&D. Every time someone touches a piece of paper, there are costs and delays,” Shields Uehling says.
SAFE, an acronym for Signatures and Authentication For Everyone, is an enabling technology that allows members to submit electronic documents to regulatory agencies and to each other, with the knowledge that the signatures on those documents can be trusted with 100 percent certainty. The technology provides the identity of the signer, the time of signature and confirms that no information has been altered since the electronic signature was made. SAFE-enabled digital signatures are legally binding.
SAFE signatures are made possible through the use of a Public Key Infrastructure (PKI), which is a system of hardware, software, people and processes that create a secure digital environment. The structure includes key pairs, digital certificates, and the SAFE Bridge Certification Authority to facilitate a verifiable association between the public key it maintains and the specific member possessing the corresponding private key. This arrangement enables cross-certification among member companies and between members and federal agencies that maintain portals, such as the Electronic Submissions Gateway for regulatory submissions.
Digital signatures have been part of the business landscape for a number of years, but because of the complex nature of the biopharmaceutical and medical industries, and the number of internal and external stakeholders, the industry-wide standard is an important step forward. The SAFE standard eliminates the inefficiencies surrounding the multiple usernames, passwords, or tokens that companies have had to maintain in their dealings with various organizations.
Regulatory agencies, such as the FDA and the European Medicines Agency (EMEA), are supporters of the SAFE standard. “FDA has been involved with SAFE since its inception,” explains Shields Uehling. “They worked with us to develop [a standard operating procedure] matrix for member companies. The Agency believes it is a worthwhile effort and has referenced SAFE as supporting the Prescription Drug User Fee Act (PDUFA III) mandate of developing tools to enhance electronic submissions, including enabling the use of 21 CFR Part 11-compliant digital signatures.” SAFE-BioPharma has also worked closely with EMEA for recognition of the SAFE standard and the expanded use of electronic submissions in Europe.
SAFE-BioPharma signed a memorandum of understanding in August with CRIX International, a not-for-profit member-based organization dedicated to leveraging technology to accelerate interactions between sponsors and their clinical partners. CRIX is attempting to build a global portal that would facilitate the exchange of regulated clinical research data among its members, and through this collaboration, would incorporate SAFE-BioPharma’s identity management and digital signature standards.
“Combining the capabilities of SAFE and CRIX is a significant step toward the future of making pharmaceutical research and development fully electronic," Shields Uehling remarks.
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