Life science companies face enormous scientific, economic, and regulatory challenges during development of medical products. While the growth of R&D has always been intertwined with technological advances, it has not been the case for regulatory compliance. The situation changed with the advent of 21 CFR Part 11, the watershed regulation that established the criteria for the use of electronic records and electronic signatures by organizations under the jurisdiction of the U.S. Food and Drug Administration.
Since 2000, we have benefited from a technology-driven era in regulatory compliance. The book identifies 16 laws and initiatives that have helped spur such modernization. It explores how the use of technology in the past decade has helped both sides of the fence—regulated companies and regulatory agencies—in easing the pains and costs of compliance.
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