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Executive Summary

FDA CONSIDERING REGULATION CHANGES TO ALLOW ELECTRONIC SIGNATURES in place of handwritten signatures, the agency reported in a July 21 Federal Register "notice of proposed rulemaking." The decision on whether to proceed with developing new regulations, FDA states, will be based on information and comments submitted in response to the notice, "the recommendations and findings of the agency's Task Force on Electronic Identification/Signatures, and the agency's experience with alternatives to conventional handwritten signatures." The agency is evaluating the use of electronic identification/signatures in three contexts: **records maintained by industry that are subject to FDA inspection ** records submitted to FDA for review and approval, and ** the agency's own records and notifications to industry, for example, through electronic mail. Comments to the agency should address how these three categories of records "may or may not lend themselves to the use of electronic identification signatures," the notice states. Pressure on the agency to address the use of electronic signatures has come from the Pharmaceutical Manufacturers Association and other industry groups who are urging the agency to accommodate the greater use of automated systems and paperless electronic records in drug manufacturing and laboratory operations. The transition from paper records containing traditional handwritten signatures to paperless electronic records, FDA explains, raises a set of "complex" issues relating to FDA acceptance of alternatives to handwritten signatures extending across the current good manufacturing practices (CGMPs) as well as several other sections of the regulations. Although signatures are required for a variety of records, FDA's current regulations do not clearly define "signature" or provide consistent requirements on the use of electronic sign-off methods. The agency set up a task force to help address the issues on an agency-wide basis in late 1991. The task force produced an initial report in February recommending that the agency "gather the widest possible public comment on the myriad of complex issues attendant to electronic identification" and then publish "regulations and guidance documents" providing for an acceptable use of the electronic signature methods. FDA is seeking comment on six specific issues identified in the task force report as pivotal in providing for handwritten signature alternatives: regulatory acceptability, enforcement integrity, security, validation, outside standards, and freedom of information requests. The comment period on the Federal Register notice ends October 19, 1992.

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