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A coalition of drug companies, government agencies, and industry groups is working toward an electronic signature standard. The most recently completed version includes technical specifications, policies, and a legal infrastructure. A pilot version will be released soon in Europe.
Drug companies use electronic signatures when submitting documents to government regulators and to business partners. A single standard is expected to lower costs, increase interoperability, and eliminate some proprietary standards.
The initiative for a single standard is called Secure Access for Everyone, or SAFE. Participants include major pharmaceutical companies, European and U.S. regulatory agencies, and industry groups.
To see the SAFE site, visitwww.safe-biopharma.org.