Document Control Systems Helps FDA-regulated Customers “Go Live” with MasterControl³ in Less than 4-months from Time of Purchase through Implementation and Complete Validation

MedTech and Cholestech Go Live on MasterControl

SALT LAKE CITY – August 4, 2004 – Document Control Systems, Inc. (DCS), provider of integrated quality management software systems continues to accelerate the time it takes DCS customers to go live with the MasterControl3 Quality Management Software Suite. The most recent to go live are FDA-regulated organizations MedTech Group and Cholestech Corporation. MedTech is a leading manufacturer of medical devices and components. Cholestech is a developer of diagnostic tools and information for immediate risk assessment and therapeutic monitoring of heart disease and diabetes.

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 to help properly validate the system to meet Good Manufacturing Practices (GMP) and achieve compliance with 21 CFR Part 11. “Our complete validation and consulting services provided gold-standard, FDA mandated quality and compliance practices that allowed these customers to go live with MasterControl³ in less than 4 months, “ said Carl J. Accettura, Sr. Vice President, FDA Solutions at DCS. “By using our full line of validation packages and services to complete the validation of the system, each company saved valuable time, energy and resources.”

DCS’ Complete Validation Offerings
DCS follows Good Automated Manufacturing Practice (GAMP®) guidelines for computer systems validation. The company offers detailed validation packages to ensure that proper validation is performed to ensure its customers comply with cGMP’s and 21 CFR Part 11. Validation packages include:

--Installation Qualification (IQ), Operation Qualification (OQ) Protocols and Tool Kit
--IQ, OQ, Onsite Support Services
--Consulting Services for Complete GXP-compliant Validation including Performance Qualification (PQ)

About Document Control Systems
Document Control Systems, Inc. has been providing innovative 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.

The MasterControl³ Quality Management Suite consists of configurable, off-the-shelf products seamlessly integrated to 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 a quality implementation. To receive detailed information about DCS validation packages and consulting services, contact the company at: http://www.mastercontrol.com. Or, call 800-825-9117.