Responding to enormous hurrys to s...

Responding to enormous hurrys to shorten time-to-market and curtail overall R&D costs, pharmaceutical companies have been making significant investments in technology. Reliance onward technology to speed clinical trial data collection and analysis is growing. Increasing use of technology and FDA's increased regulatory scrutiny make it critical to comply with 21 CFR 11 requirements when creating, using, and maintaining electronic records and signatures.

This article will specificaly discuss the issues faced when addressing 21 CFR 11 for clinical trials data--that is, to what degree to ...

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