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ICONICS GENESIS32 v7.0 FDA 21 CFR 11 Solutions

March 3, 2003 ICONICS is a leader in the development of Web-enabled industrial automation software for the Microsoft Windows operating systems, today announced that version 7.0 of GENESIS32 offers a wide variety of tools for helping companies to comply with the FDA 21CFR11 regulations. GENESIS32 enables proper handling and recording of FDA-regulated electronic information and applies "electronic signatures" such that the FDA considers them to be "equivalent" to that of handwritten signatures and documents.

"Pharmaceutical companies, food processing plants and others hoping to comply with this regulation now have powerful Plug and Play features offered by the ICONICS HMI / SCADA product," comments Russ Agrusa, ICONICS President and CEO. "The regulations were carefully reviewed and a significant effort has been made in this product release to provide the tools required for projects needing FDA compliance."

Several ICONICS GENESIS32 components are utilized for meeting these FDA regulations. ICONICS GenEvent Server tracks operator changes, user logins and system events, producing a secure audit trail for an application. A comprehensive security system is deployed not only on each workstation, but also across the network to restrict access, track users, and provide an environment that meets the standards of the FDA.

Web-enabled systems and those deploying the ICONICS WebHMI package will also find the ICONICS FDA solutions ready to plug into their system. Operator comments on alarms and events, setpoint entries, unique IDs and other elements are deployed across the Internet as easily as they are on a local area network.

"The features found in the ICONICS components offer a valuable solution for our industrial customers requiring FDA compliance," states Bob Braier, Director of Product Deployment for ICONICS. "The detailed options available are extensive and simple to implement."

GENESIS32 has been successfully deployed and approved in FDA-regulated applications around the globe. ICONICS software is ready to assist in complying with FDA 21CFR11.

For more information please contact ICONICS at (508) 543-8600 or info@iconics.com, or visit the ICONICS Web site at www.iconics.com.

ICONICS Background Information

Founded in 1986, ICONICS is a leader in the development of Web-enabled industrial automation software for Microsoft® Windows® operating systems. Offering the industry's only suite of fully-integrated OPC-based components and products, GENESIS32 Enterprise Edition is available for Windows XP, 95, 98, Millennium, and 2000, and Windows NT®. Pocket GENESIS for Windows CE and Pocket PC was built from the ground up based on ICONICS' OPC-To-The-Core framework. ICONICS offers a complete set of Plug and Play automation components, including best-in-class OPC ActiveX® Controls, OPC Toolkit, Human Machine Interface (HMI), Microsoft SQL Server®based data logging, Multimedia Alarming, and Supervisory Control and Data Acquisition (SCADA) products. ICONICS is represented in over 50 countries and has in excess of 100,000 product installations worldwide. Visit us online at www.iconics.com.

© 2002 ICONICS, Inc. All rights reserved. GENESIS, GENESIS32, Pocket GENESIS, GraphWorX, AlarmWorX, TrendWorX, ProjectWorX, ReportWorX, TraceWorX, WebHMI, MobileHMI, GenBroker, ControlWorX, ToolWorX, ToolBoX, GENESIS for Windows (GFW), GENESIS BizViz, Visualize Your Enterprise, and OPC-To-The-Core are trademarks of ICONICS Inc. Microsoft, Windows, ActiveX, Visual C++, Windows NT, and Visual Basic are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. IBM and PC are trademarks of International Business Machines Corp. Other product and company names mentioned herein may be trademarks of their respective owners.

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