Document Control Systems’ (DCS) Quality Management Software Suite Powers the Blood Services Industry

Central Blood Bank, LifeSource and Travis County Blood & Tissue Center Select MasterControl

SALT LAKE CITY – October 7, 2004 – Document Control Systems (DCS) announced today that Central Blood Bank, LifeSource and Travis County Blood and Tissue Center selected the MasterControl Quality Management Software Suite to automate their critical paper-based corporate and quality management processes. DCS was selected because of its connected and easy to use applications along with domain expertise and comprehensive validation services. MasterControl’s intuitive interface, powerful graphical-based tools for route creation, electronic approval, and integrated electronic forms will be used to help these blood establishments automate processes like document control, change management, training control, corrective and preventive actions (CAPA), deviations, audits, and others to ensure compliance in this strictly regulated industry.

In addition to purchasing the MasterControl³ Quality Management Suite, both companies selected DCS to provided all the validation documentation, protocols, tool kits and complete GXP-compliant validation services. DCS uses the GAMP®4 methodology to help properly validate the system to meet Good Manufacturing Practices (GMP) and achieve compliance with 21 CFR Part 11. See related press release about DCS validation services

Blood Products Companies have the Most Frequent FDA Inspections
FDA targeted in 2004 to inspect 50 percent of the approximately 2,700 registered blood banks, source plasma operations, and biologics manufacturing establishments to reduce the risk of product contamination. The mission of the FDA Blood Program is to ensure that blood, blood products, biotechnology-derived hematologics, and devices associated with their manufacture and use, are safe, effective, and adequately labeled. To ensure that these products are safe, the Agency must oversee their entire life cycle -- from production through distribution, and use/consumption.

“FDA Inspections of facilities are targeted to ensure that products are being manufactured according to Good Manufacturing Practices (GMPs), and that these standards are based on rigorous science and sound quality control principles. Also, blood organizations are scrutinized under 21 CFR GMP’s for drugs (Part 210/211), biologics (Part 600/610) and blood/blood components (Part 606), regulations that fall under both FDA’s Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) branches,” said Carl J. Accettura, Sr. Vice President of FDA Solutions at DCS. “Since blood is so universally needed, quality must not be compromised. The blood supply is critical to the nation's health care system, and each year approximately 14-million blood units are drawn from volunteer donors for use in more than 3.5 million Americans. FDA vigorously continues to strengthen its efforts to protect the nation's blood supply and to minimize any risk to patients of acquiring HIV, hepatitis, Creutzfeldt-Jakob disease (CJD), and other blood-borne diseases. MasterControl has proven to help blood companies to dramatically improve efficiency and ensure high quality blood products and services.”

DCS Helps Blood Industry Improve Efficiency and Ensure Compliance
Central Blood Bank, LifeSource and Travis County Blood & Tissue Center join DCS blood service companies like ARUP Labs, Blood Center of Iowa, Memorial Blood and many other blood-related establishments which are already using MasterControl to improve product quality and ensure compliance with strict FDA regulations like 21 CFR Part 11 and 21 CFR Part 606.

About Document Control Systems
Document Control Systems, Inc. has been at the forefront of providing innovative electronic quality management systems since 1993. The company was the first to develop software that enables compliance with FDA 21 CFR Part 11. Today, hundreds of companies worldwide use MasterControl to consistently meet FDA regulatory requirements and industry quality standards, including ISO and QS/TS.

MasterControl’s configurable, off-the-shelf products are designed to integrate seamlessly and significantly accelerate installation, implementation and validation efforts. Its centralized interface provides maximum ease-of-use. DCS offers unmatched technical assistance, complete GAMP®4 methodology validation consulting services and extensive training to ensure the quality implementation of its MasterControl3 Quality Management Suite. On the Net: Document Control Systems’ site: http://www.mastercontrol.com. Or, call 800-825-9117.