Simplifying Global Compliance
Articles Tagged with ''Part 11''
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. Read More
The FDA’s lack of 21 CFR Part 11 enforcement should not leave the false impression that erecord integrity doesn’t matter so much anymore, experts recently stressed to PIR. Read More
Regardless of when, how or if the FDA ever strenuously enforces 21 CFR Part 11, regulated life sciences companies would be well-served to proactively approach compliance efforts with an eye on the business case, experts stress. Read More
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. Read More
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. Read More
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. Read More
Historical and practical barriers to using electronic data capture (EDC) in clinical trials are falling worldwide, experts say. Read More
PLIVA-Lachema, the Czech affiliate of multinational specialty pharmaceutical manufacturer PLIVA, has chosen Sparta Systems’ TrackWise software to electronically manage its quality and regulatory processes. Read More
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