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Automation Portals

November 2001

ICONICS GENESIS32 FDA 21 CFR 11 Solutions

SPS/IPC/Drives, November 2001, Nuremberg, Germany *
ICONICS, a leader in the development of Web-enabled OPC based industrial automation software for MicrosoftÒ WindowsÒ operating systems, announced that version 6.1 of GENESIS32 offers a wide variety of tools for complying with the FDA 21CFR11 regulations. It 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 affected by this regulation are enjoying the plug-n-play features offered by our HMI package comments Chris Volpe, ICONICS Vice-President, A significant effort has been made in this release to provide the tools required for FDA projects.

GENESIS32 components such as GenEvent Server track operator changes, user logins, and system events, producing an audit trail for the system. A tight security system is deployed not only on each workstation, but across the network as well for restricting access, tracking users, and providing an envirement suitable for the FDA.

Web-centric systems and those deploying our 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 it is on a local area network.

The features found in the ICONICS components offer a valuable solution for our HVAC customers requiring FDA compliance, says Steve Thompson, Director of Global Product Marketing for Johnson Controls. The detailed options available are incredible.

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 visit their website at www.iconics.comor info@iconics.com.

ICONICS Background Information
Founded in 1986, ICONICS is a leader in the development of industrial automation software for Microsoftâ Windowsâ Operating Systems. The company offers the industrys only suite of fully integrated OPC-Based components and products: GENESIS32 Enterprise Edition, available for Windows 95/98/NT, Millennium and 2000; and Pocket GENESIS available for the Pocket PC and Windows CE. Both were built from the ground up based on ICONICS OPC-To-The-CoreTM 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), SQL based Data Logging and Supervisory Control and Data Acquisition (SCADA) products. The companys products are fully WEB enabled. ICONICS is represented in over 50 countries and has in excess of 50,000 product installations worldwide. For more information visit www.iconics.com, or E-mail to info@iconics.com.
GENESIS32, Pocket GENESIS, AlarmWorX, ControlWorX, GraphWorX, TrendWorX, ToolWorX, ToolBoX, WebHMI, MobileHMI, and OPC-To-The-Core are trademarks of ICONICS, Inc. Microsoft, Windows, ActiveX, Visual C++, Pocket PC, Windows CE, Windows NT, and Visual Basic are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. Other product and company names mentioned herein may be the trademarks of their respective owners.

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