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Jun 7, 2010 - Oklahoma Blood Institute Manages QC using Sigma Blood QC Manager

Sigma Blood Systems Deploys QC Manager at Oklahoma Blood Institute

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Oklahoma City-based Sigma Blood Systems has released a new software application called that helps blood banks collect quality control data about the products they produce.

The tracking capabilities of QC ManagerTM helps blood centers meet strict quality control compliance requirements from the Food and Drug Administration (FDA).

"The QC ManagerTM module helps blood centers automate and accurately track the quality control process for all blood components set for qualification," said Max Doleh, founder and CEO at Sigma Blood Systems. "These include assurances that the products meet specifications and efficacy requirements. QC ManagerTM helps blood centers monitor their compliance with applicable FDA acceptance criteria."

The software also detects system-wide failures on different levels and provides insights into less-than-optimal practices, Doleh said. It contains all the required statistics models and algorithms necessary to manage the quality assurance process.

QC ManagerTM went live at the Oklahoma Blood Institute on June 1.  The Oklahoma Blood Institute served as a beta test site during the QC ManagerTM development process and is the first blood center to adopt it for day-to-day quality control tracking.

QC ManagerTM is the latest among a suite of software apps created by Sigma Blood Systems specifically for the nation's blood collection agencies. It joins Sigma Blood Systems software applications called Blood TrackerTM and Platelet ManagerTM that also were developed for blood centers.

"QC ManagerTM benefits the Oklahoma Blood Institute in several ways", said Kim van Antwerpen, OBI's Vice President of Technical Operations.

The software tracks the number of blood products tested by the blood center, as well as the locations from which they were collected. OBI operates collection centers in Oklahoma City, Ardmore, Ada, Lawton, Enid, Ponca City and Tulsa, as well as Texas Blood Institute, its affiliate in Wichita Falls, Texas.

Another area in which QC ManagerTM excels is that of complex statistical sampling required by the FDA, van Antwerpen said.

"Instead of blood centers having to hire statisticians or figuring out what statistical plan is appropriate, QC ManagerTM helps you keep track of the appropriate number in what we call a rolling window," she said. "The whole statistics program within QC ManagerTM is all about process controls and making sure you meet FDA regulations."

QC ManagerTM can be operated as a standalone Web application at a client site or in a hosted environment, Doleh said. It can also integrate with Sigma Blood Platelet ManagerTM software, which helps blood center optimize their manufacturing of platelet products.

Sigma Blood Systems' original Blood Tracker helps blood collection centers track the flow of blood from the time it leaves the arm of a donor to the point where it becomes the "gift of life" to a patient in need of blood products.

"QC ManagerTM is built on Sigma's flexible framework that allows for quick customization and integration with other existing systems to get a complete picture for a blood center's operation," Doleh said.

For more details regarding , please call Sigma Blood Systems at 405-227-0606.

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