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Merck Millipore Guava easyCyte™ Systems for Compliance with 21 CFR Part 11
Merck Millipore Guava easyCyte™ Systems for Compliance with 21 CFR Part 11
31 Dec 2015This white paper provides a summary of how the easyCyte™ system addresses the regulatory requirements outlined by 21 CFR Part 11. 21 CFR Part 11 is the United States Food and Drug Administration (U.S. FDA) regulation, directing the management of electronic records and electronic signatures in open and closed systems. The regulation became effective in March 1997 and Merck Millipore’s guava® instruments featuring CytoSoft™ and guavaSoft™ software were designed to facilitate user compliance with 21 CFR Part 11.
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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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High-Throughput ScreeningHigh-throughput screening (HTS) is an automated drug discovery technique for identification of active compounds against a compound library. Use HTS readers and integrated assay preparation / analysis workstations to screen your compounds. Identify active compounds against various HTS libraries, including membranes, proteins and peptides and HTS cell lines. Find the best high-throughput screening products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.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.Flow Cytometry / Cell CountingFlow cytometers are used to count, sort and examine multiple characteristics of cells. Other cell analysis equipment includes image cytometers, cell counters, fluorescence-activated cell sorters (FACS), magnetic-activated cell sorters (MACS), and a range of flow cytometry assay kits. Flow cytometers can reveal information on cell viability, cell proliferation, apoptosis and cell cycle progression, as well as identify cell populations and intracellular or cell-surface molecules. Additionally, some flow cytometers, known as FACS, have an additional sorting function after analysis. Cell counters and image cytometers count live and dead cell populations and can also conduct cell proliferation assays. Find the best flow cytometers, cell counters and cell sorters in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Cell-Based AssaysCell-based assays are used to monitor the presence, quantity and activities of a desired cellular analyte including drug molecules or biomarkers. This can reveal information on cell health (apoptosis, cytotoxicity, viability and proliferation assays), cell metabolism, cell migration and cell signaling mechanisms. Find the best cell-based assay products, kits and equipment with our peer reviewed product directory: compare products, check customer reviews and receiving pricing direct from manufacturers.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.Microplate Reader SoftwareAutomationAutomation in laboratories and manufacturing processes enhances efficiency, precision, and scalability by reducing the need for manual intervention. It plays a critical role in improving productivity, minimizing human error, and accelerating workflows in fields like diagnostics, drug development, and industrial testing. Automation technologies include robotic systems, automated liquid handlers, and process control systems that streamline complex tasks and ensure consistent, reproducible results. Explore our peer-reviewed product directory to discover the best automation solutions, compare options, read user reviews, and get prices directly from manufacturers.Fluorescence Based AssayFluorescence based assays are widely used in life science research and high-throughput screening to measure a broad range of cellular activities.Cell AnalysisThe analysis of cells allows researchers to understand the factors which contribute to cell health and function. These influencing processes can then be predicted and altered, leading to the development of medication and disease treatments.High ThroughputHigh throughput experiments allow the simultaneous processing of several samples. This parallelization reduces the cost per experiment and increases reproducibility and output volume of data.Cell SortingCell sorting isolates specific cell populations based on physical or molecular characteristics, essential in immunology, cancer research, and regenerative medicine. Techniques like flow cytometry improve accuracy and speed. Compare cell sorting instruments and solutions in our product directory.