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21 CFR Part 11 - An overview

As companies gear up for greater use of e-solutions in clinical studies, the author presents a guide to 21 CFR Part 11 establishing regulations and criteria for acceptance by the US FDA of electronic records and signatures.

Dr Paul Bleicher, Phase Forward Incorporated (January 2003)

Keywords: clinical research, clinical trial supplies, post-marketing surveillance, regulatory and approval services, regulatory data, drug patent, drug registration, Phase Forward, e-solutions, 21 CFR Part 11

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