Ensuring FDA Compliance: The Essential Guide To FDA 21 CFR Part 11

FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper. This helps organizations reduce the cost of managing and documenting their entire labeling lifecycle, from routing and approval workflow, version control and comparison, to audit trails and reports. The regulation applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of medical product. Download the full paper for more information.