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OPC Alarm Notification S/W is helping organizations to achieve FDA's 21 CFR Part 11 compliancy
May 2006 - Control-See Software Solutions Ltd, a leading provider of Alarm Notification & Analysis software tools, introduces compliancy with FDA's 21 CFR part 11 for its U.C.ME-OPC™ software product version 6.0.
The FDA is stepping up regulatory enforcement. Is
your facility audit-ready? If not, your company is faced with possible Notices
of Inspectional Observations (483s) Warning Letters — even substantial fines and
Achieving compliance is no small task. Its scope extends beyond a company’s environmental and production control systems and operating procedures — into virtually every area of the plant and across entire regulated industry supply chains. Today’s Biotech, Pharmaceutical, and other FDA-regulated industries are quickly realizing the importance of 21 CFR Part 11 compliance. They’re viewing Part 11 not as a burden, but as an opportunity to improve their manufacturing process and their entire business. By moving to a fully “paperless” environment, companies can reduce costs, accelerate time-to-market, and ensure a higher degree of quality and consistency in their products. As a result, these companies gain a powerful Competitive advantage.
How can U.C.ME-OPC help you achieving compliancy?
• Electronic records of every operator action (change in alarm configuration) electronically signed with explanatory text and securely logged to a database.
• Password expiration and Minimum length.
• Confidentiality enforcement – only authorized user can add, edit or view any data.
• User-specific inactivity time-out periods.
• Operators must provide an electronically signed explanation of their actions (system changes).
• Full accountability and traceability supported by automatic capture of who?, what?, when?, and why? - related information.
• Multiple customizable views — sort and filter by date/time, operator etc.
• Export reports to HTML
About Control See Software Solutions
Control-See was founded in 1994. Its main business is alarm notification and analysis software. U.C.ME is OPC client alarm notification and analysis software. It uses SMS, WAP, RSS, Phone, Fax, Email and Multimedia to notify users on alarm situations. U.C.ME is an OPC client and DDE client software. It can connect to any OPC or DDE server or any SCADA that supports OPC/DDE. U.C.ME supports bidirectional communication via SMS and Phone. Users may acknowledge alarms, query or change tag values via SMS or phone. Solutions: Building management, Security systems, Industrial control, Water treatment, Healthcare and more. Visit Control-See website at www.controlsee.com
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