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Monthly Archives: February 2012
Is Facebook a Validated System?
Well, of course the answer to the question posed in the title is a clear “No”…. at least as far as the pharmaceutical and biopharmaceutical industry understands and interprets validation. So why the question? My eye was drawn to an … Continue reading
Posted in e-records, Regulations
Tagged biopharmaceutical industry, validation requirements
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Ensure Your Informed Consent Forms Comply With New Requirements
For those sponsors conducting clinical trials that need to comply with FDA regulations, remember that from 7th March 2012 your informed consent documentation must comply with the new 21 CFR § 50.25(c) requirement. This requires the informed consent form to … Continue reading
Posted in Compliance, Regulations
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