Articles Tagged with ''Part 11''

Part 11 Compliance Requires Strong, Targeted SOPs

Compliance with 21 CFR Part 11 demands that an FDA-regulated life-sciences company use a set of three key system-specific standard operating procedures (SOPs) to support validation efforts, says a new white paper from industry vendor MasterControl.

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Enforcement Lulls as New Part 11 Rule Looms

With smart money betting the FDA won’t release its revised 21 CFR Part 11 rule until the end of the summer or even early fall, the agency’s lack of visible enforcement is sending some mixed signals to industry, experts told PIR.

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iAdvantage Taps TRG For Help Desk Support

iAdvantage Software, a provider of software solutions for managing development and preclinical life science studies, said May 9 it selected Tech Resource Group (TRG), to provide the help desk support for its 21 CFR Part 11-compliant eStudy hosted solution.

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Amgen Striving for All Electronic Data Capture

Amgen is trying to achieve 100 percent use of electronic data capture (EDC) in its clinical trials by the end of 2007, although the business case is not as strong as initially expected, according to clinical data management manager Kevin Reidy.

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