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FDA Seeks Part 11 Expertise

This article was originally published in The Gold Sheet

Executive Summary

The Office of Compliance in FDA's Center for Drug Evaluation and Research is seeking outside help to assist the agency in preparing a revised Part 11 regulation governing the use of electronic records and signatures. FDA's primary goal under Part 11 is to regulate electronic records and electronic signature so that they could be treated as generally equivalent to paper records. A proposed rule was published in August 1997 but has yet to be finalized. Part 11 was intended to address security concerns associated with electronic records and signatures while permitting the widest use of electronic technology. Many in the pharmaceutical industry have complained, however, that the current Part 11 approach is overly prescriptive and has failed to adapt to changing technologies. In the May 21 solicitation notice, FDA said the contract would include preparing, editing and reviewing pharmaceutical industry comments on the 21 CFR Part 11 regulation. Further, since additional guidance for industry may be required in that the regulation will be changed, the contractor would also assist with material necessary for the preparation and publication of draft and final industry guidance. FDA intends to make its selection for the one-year contract on Aug. 1

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