Beckman Coulter Introduces Q-Check Quality Certification Program For Quanta Flow Cytometers
Beckman Coulter, Inc. announced the Q-Check program for the company's Quanta SC and Quanta SC MPL flow cytometers, providing tools for installation and operational qualification (IQ and OQ). Q-Check is a comprehensive package that includes the necessary elements to document the installation and operational qualification of the instrument. The Q-Check kit is ideal for drug discovery and pharmaceutical flow cytometry applications where users need to comply with cGMP and GLP regulatory guidelines. Q-Check also provides a section for routine performance qualifications and material modules for subsequent annual recertification.
"Instrument qualification can be very time-consuming and confusing, especially for first-time systems users," commented Karen Bezold, director of the Cellular Analysis Business Center for Beckman Coulter. "Because our own company operates under cGMP guidelines, we are in the ideal position to help our customers with these regulations. We provide a comprehensive package with step-by-step instructions and signed certificates to save our customers time and give them peace of mind."
Q-Check addresses required aspects for proper instrument validation including specification qualification (SQ), design qualification (DQ), IQ, OQ and performance qualification (PQ), from product development to ongoing performance verification. The program is designed to give the user assurance that the Quanta SC and SC MPL systems will perform on a consistent basis in the certified applications.
The Quanta SC is an advanced and cost-effective flow cytometer for a wide variety of multicolor applications in life science, drug discovery and basic clinical research. It features three-color fluorescence, side scatter, electronic volume and absolute count measurements along with easy-to-use software, automated color compensation and multiple excitation wavelengths including UV. The Multi-Platform Loader (MPL) upgrade option provides additional flexibility, enabling the handling of samples in both plates and tubes and sample preparation prior to acquisition. An optional software package supports 21 CFR part 11 compliance with features such as administrator-defined user access and data file audit trails.
Beckman Coulter, Inc., based in Fullerton, California, develops, manufactures and markets products that simplify, automate and innovate complex biomedical tests. More than 200,000 Beckman Coulter systems operate in laboratories around the world supplying critical information for improving patient health and reducing the cost of care. Recurring revenue, consisting of supplies, test kits, service and operating-type lease payments, represents more than 75 percent of the company's 2006 annual revenue of $2.53B. For more information, visit www.beckmancoulter.com.
SOURCE: Beckman Coulter, Inc.