ResourceEnvironmental
Quality Control Electronic Records for 21CFR Part 11 Compliance
10 May 2017This whitepaper describes how Quality Control instruments can be optimized for pharmaceutical use, helping to improve the integrity of the data in the final electronic record. It details SOPs (Standard Operating Procedures), final product quality control and cleanroom environmental monitoring.
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Environmental Monitoring and TestingEnvironmental monitoring and testing uses handheld portable analyzers, kits, spectrometers or chromatography systems for air, water, soil, food and other sample testing. Useful features of analyzers such as BOD and COD include portability, easy calibration, automation and sensitivity. Environmental test kits for pH, water, moisture, etc, should be accurate, sensitive, reliable, fast and easy to use.FDAThe Food and Drug Association (FDA) is an agency within the U.S. Department of Health and Human Services. Among other things, it is responsible for ensuring the safety, effectiveness and quality of drugs, vaccines and other biological products, and medical devices. Environmental ContaminationContaminants in the environment are harmful chemicals that are present in the air, land and water. These include pesticides, pharmaceuticals, persistent organic pollutants (POPs) and many more.Environmental AnalysisEnvironmental analysis describes a variety of tests that determine the effect of chemicals, processes and particulates such as persistent organic pollutants (POPs) have on the environment.Data AcquisitionData acquisition refers to the collection and organization of information and data sets.Air QualityGood Manufacturing Practice