Reglera and ReproTech Unveil Groundbreaking Donor Eligibility Determination System.

First of Its Kind Web-Based System Greatly Increases Regulatory Compliance for Human Cells, Tissue, and Cellular and Tissue Based Products (HCT/P's) Industry

LAKEWOOD, Colo. -- Reglera Corporation announced today the release of its web-accessible Donor Eligibility Determination System. This validated system, co-created with ReproTech Limited, is revolutionary, identifying risk areas in the donor file for review by the medical director. The system provides tissue organizations with the ability to fully automate the donor eligibility determination process, using validated smart logic to automatically identify high risk areas and non-compliances, thereby increasing the compliance of the eligibility determination.

The system comprehensively guides the eligibility process, electronically manages the donor file, and even creates the required Summary of Records for each donor. "Donor eligibility determination has historically been one of the most difficult aspects of tissue regulation for HCT/P organizations to comply with," says Lori Hardwick, Director of Outsourced Services for Reglera. "This system is designed to comply with 21 CFR 1271 and Part 11, and, because the system is automated and identifies non-compliances within the donor file, it decreases the likelihood of human errors occurring. The fact that the system is also web-accessible facilitates the eligibility process, allowing organizations with geographically diverse facilities to communicate with less paperwork and greater ease regarding the determination."

Reglera concluded the beta testing phase of the system in late October. "The feedback received from our beta customers was invaluable," says Hardwick. "Incorporating their suggestions has only increased the effectiveness of the system." Beta customers are extremely excited about the usability of the application. Dr. Michael Bauer, medical director for several accredited tissue organizations, affirms, "This is far and away the simplest, most effective donor eligibility tool I've seen. It is intuitive, user friendly, and GTP [Good Tissue Practices] compliant."

The ease of use and ability to access the system from any web-enabled device are sure to aid HCT/P organizations in their determination process as well. Ultimately, this system is a tool that increases compliance with FDA regulations regarding HCT/P donation while helping to minimize human error.

Reglera is one of the largest and fastest growing regulatory consulting and outsourcing companies in the world. Specializing in the medical device and human tissue industries, Reglera provides companies with products and services that cover a wide variety of technical and support areas. Whether you need assistance with the FDA or are simply trying to comply with the myriad of regulations and standards, Reglera's products and services will accelerate your success and profitability.

For more information regarding Reglera's Electronic Donor Eligibility System, or to schedule a live demonstration, please contact Brian Eslinger at 1-800-341-4255, or email [e-mail].