Qualification PErformance Module Sigma Blood

Automated Compliance with the 2007 FDA Guidance Document for the Collection of Platelets by Automated Methods.

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Qualification Performance Module Patent Pending

Sigma Blood's Qualification Performance Module™ was specifically designed to address the 2007 FDA Guidance Document for the Collection of Platelets by Automated Methods.

This module is the first in the industry to automate the guidance document using Scan Statistics. The Scan Statistics method is more precise, efficient and flexible than either manual charts and tables or simple binomial distribution.

Qualification Performance Module™ Features

  • Pre-defined and customizable work flow using Scan Statistics
  • Automatic sample size management
  • Customizable sample size windows (by site, product, test type, collection technology, and quantity)
  • All required models and algorithms
  • Real-time reports instantly

Immediate ROI

  • Significant cost savings in terms of labor costs as well as costs associated with reagents used.
  • More confidence in meeting 2007 Guidance Document
  • Reduce time associated with tracking platelet QC.

Call us now to learn more about the Qualification Performance Module and how it may help you optimize your operation.

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"Sigma Blood consistently demonstrates great value with measurable results to our processes and to the bottom line." Oklahoma Blood Institute.

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