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FDA time-stamp guidance

This article was originally published in The Tan Sheet

Executive Summary

Compliance should "establish and follow procedures to detect and deter inappropriate changes to computer clocks," agency says in draft guidance on computer-generated time stamps for Part 11 electronic records. "Employees should be made aware that unauthorized changes to clock settings are serious and unacceptable actions," FDA says, adding training programs "are especially important where computer systems lack a technical means for preventing people from changing clock settings." Agency also urges spot-checking of e-record time stamps for anomalies that might indicate inappropriate clock settings, such as when "the time stamps in an audit trail show a data and time or record modification that is earlier than the date and time of record creation." Comments on draft guidance are due June 18...
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