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Observation   1. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your firm manufactures over-the-counter (OTC) drug products, including alcohol-based hand sanitizers[1]. During the inspection of your facility, our investigator attempted …

USFDA 483 on Access Management of Computerized System Read More »

Clinical data management leads to generation of high-quality, reliable, and statistically sound data from clinical trials. This helps to produce a drastic reduction in time from drug development to marketing. It ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the …

Clinical Data Management Read More »