21 CFR Part 11 Software for Automated Benchtop Flow Cytometry System
Beckman Coulter introduces new 21 CFR Part 11 software for the Cytomics FC 500 MPL flow cytometer. The new system, with streamlined setup and analysis capabilities, automates tube and microplate-based assays for increased throughput, all in a secure and validated environment. Its multi-platform loader enables cellular and bead-based analysis of samples in tubes or a variety of 24- and 96-well plates. Ideal for biotech and pharmaceutical research applications, the 21 CFR Part 11 module offers password-enforced login and inactivity timeouts, complete audit trails, data archival/retrieval and electronic signatures.
The FC 500 MPL provides five-color analysis from a singe laser, enabling the study of more analytes per tube, while an optional dual laser excitation capability adds another level of flexibility. New features, such as variable sample aspiration and mixing cycles, allow the user to select settings that best meets the needs of the application. Users can choose from thousands of available reagents or use Beckman Coulter’s Custom Design Service for specialized assays.
“Flow cytometry is rapidly growing as a drug discovery and disease research tool, with today’s focus on systems biology,” commented Diane Lary, Cellular Analysis Product Manager for Beckman Coulter. “We are uniquely positioned to bring our strength in clinical diagnostic flow cytometry into the growing biopharma segment.”
The FC 500 MPL is part of Beckman Coulter’s Cell Lab family of integrated cellular analysis solutions that prepare samples for analysis, identify cell characteristics, probe cell signaling pathways and sort cellular populations for further study. This systems biology approach helps researchers evaluate cellular data in a biological context to accelerate the identification and validation of signal transduction pathways that will lead to new targets of biological, diagnostic and therapeutic interest.
Beckman Coulter, Inc. is a leading manufacturer of biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum – from systems biology and clinical research to laboratory diagnostics and point-of-care testing – Beckman Coulter’s 200,000 installed systems provide essential biomedical information to enhance health care around the world. The company, based in Fullerton, Calif., reported 2003 annual sales of $2.2 billion with 64 percent of this amount generated by recurring revenue from supplies, test kits and services.
For more information, access the Beckman Coulter World Wide Web Information Service at http://www.beckmancoulter.com or call (800) 742-2345 (U.S.). Fax (800) 643-4366 (U.S.). From outside the U.S. call (714) 871-4848, or Fax (714) 773-6611.
