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Going with the flow (cytometers)
FULLERTON, Calif—In an effort to provide more complete service to its flow cytometer customers, particularly those users who are working in cGMP and GLP facilities, Beckman Coulter earlier this month announced the launch of Q-Check, a service offering that provides documentation of the installation and operational qualification of the instruments.
In particular, Q-Check is aimed to aid those Beckman customers of the company's Quanta SC and Quanta SC MPL flow cytomers who will be using the instruments in labs that require 21 CFR Part 11 compliance and performing within cGMP and GLP regulatory guidelines.
"The objective of this procedure is to ensure that the manufacturing standards and procedures are followed when the Beckman Coulter Cell Lab Quanta SC and Quanta SC MPL flow cytometer is installed," says Dr. Yong Song, marketing product manager, cellular analysis and business center for Beckman Coulter. "Installation is to be performed by Beckman Coulter field service engineers who are trained and certified on the installation process on the Q-Check kit."
Customers who want to receive the Q-Check service pay a flat fee to have the Beckman field service engineer certify their instrument and can choose to have the technician re-certify the system on a yearly basis.
According to company information, the Q-Check system provides customers with the required instrument validation including specification qualification (SQ), design qualification (DQ), installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ).
At present, Beckman is training and certifying its flow cytomer field technicians in order to support the Q-Check program. While Song says the program is too new to be able to predict how many Quanta customers will elect to use Q-Check, he is confident there is a need for this kind of service.
"Q-Check is in response to our customers who requested we provide this service to them," says Jong. "All the flow cytometer field service engineers, eventually they will all be trained and certified to perform this service."