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Part 11 guidance

This article was originally published in The Tan Sheet

Executive Summary

File conversions used to generate electronic copies of electronic records submitted to FDA must be validated, agency says in draft guidance for industry and regulators. Draft document, slated to be announced in Nov. 12 Federal Register, notes electronic copies should be in file and media formats that FDA can read and process. Agency will list appropriate formats in 1electronic records/signatures section of its Web site. Comments on draft guidance will be accepted for 90 days after publication...

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Part 11 guidance withdrawn





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