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guava easyCyte™ Systems: Support for Compliance with 21 CFR Part 11
30 Jun 2016This white paper provides a summary of how guava easyCyte™ Systems addresses the FDA regulatory requirements, which direct the management
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Guava® easyCyte™
LuminexOur microcapillary flow cytometry systems are simpler to operate than traditional sheath-fluid based instruments and are far easier to maintain. They utilize small sample volumes, generate minimal waste, and have lower operating costs. As a result, easyCyte™ Flow Cytometers are uniquely amenable to on-demand use in the laboratory environment and have helped many scientists achieve insightful cellular analysis since 1998.
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Data AnalysisData analysis hardware and software is available to make data processing straight-forward yet powerful. Data software can be used for math and stats, technical graphing and image analysis. In addition, software is available for specific data analysis of electrophoresis, densitometry, ELISA and DNA sequencing.LIMSLIMS (Laboratory Information Management System) is an informatics software system used to improve the quality assurance and quality control (QA / QC) of data management. LIMS can be a standard for common lab workflows, such as commercial off the shelf systems (COTS), or customized for more specialized lab use. Systems are available for mainframe computers or PC.Software PlatformsSoftware platforms are useful for various stages of laboratory experiments from data collection to data storage and processing. For instance lab software is available for system control, data management, data analysis and qualification / validation.Food and Beverage AnalyzersFood and Beverage Analyzers are commonly used to provide information about the chemical composition, structure and physical properties of food materials.Food and Beverage ProcessingFood and Beverage Processing involves the preparation of food products for further analysis. Typical instrumentation includes blanchers, color sorters, cookers, grinders, and refrigeration. These are used to replicate the processes commonly used in the commercial preparation of food and beverages.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. Laboratory ManagementLaboratory management involves overseeing the operations of a lab, ensuring compliance with safety regulations, optimizing workflows, and maintaining equipment. Efficient lab management is key to ensuring accurate results and minimizing downtime. Technologies like laboratory information management systems (LIMS) and automated lab equipment are helping labs streamline operations. Browse our peer-reviewed product directory to find the best laboratory management tools, compare products, read reviews, and get pricing directly from manufacturers.Data ManagementFood SafetyFood safety describes the prevention of food-borne illnesses. Contamination with a variety of pathogens can be prevented with adequate temperature control, hygiene and labeling. Food samples can be tested using GC/MS, HPLC, SPE, and qPCR to ensure their adherence to regulations.Food QualityFood quality refers to the attributes of food that influence its safety, nutrition, and taste. Monitoring and ensuring food quality are essential in production to meet health regulations and consumer expectations. Techniques like spectroscopy, chromatography, and microbial testing are used to assess food properties and detect contaminants. Browse our peer-reviewed product directory to find food quality testing solutions; compare products, check reviews, and get pricing directly from manufacturers.Regulatory