Interphex 2004: GE Fanuc launches Change Management Solution software
New York NY—GE Fanuc Automation Americas Inc. reports its new Change Management Solution software helps users track changes and control versions of automation software and devices and equipment used on the factory floor to provide a framework for achieving 21 CFR Part 11 and GmP compliance.
New York NY— GE Fanuc Automation Americas Inc. is launching its new Change Management Solution software at Interphex 2004. This software helps users in the life sciences track changes and control versions of automation software and devices and equipment used on the factory floor to provide a framework for achieving 21 CFR Part 11 and GmP compliance. GE Fanuc Automation is a unit of GE Infrastructure.
“One of the most challenging issues for manufacturers in the life sciences is the U.S. Food and Drug Administration’s (FDA) requirements for electronic records, which are defined in regulation 21 CFR Part 11, and their impact on controllers and other production device programs,” says Bob Honor, GE Fanuc Automation’s life sciences manager. “In addition to helping companies achieve compliance, this proven solution also can help users protect against plant downtime due to device failures and operator errors.”
Based on GE Fanuc’s Cimplicity Manager software, the new Change Management Solution provides electronic record keeping, electronic signature, complete audit trails, and record security. The solution is designed for 21 CFR Part 11 and cGMP regulations, and can connect to an installed base of disparate plant floor systems by using an open architecture.
Change Management Solution already has been installed and proven at pharmaceutical companies, which have been audited and validated by the FDA. “Based on existing pharmaceutical applications, GE Fanuc can provide a measurable, near-term ROI, including increased plant uptime, improved engineering processes, reduced engineering and maintenance costs, and lower capital expenses,” says Honor.
With a user-configurable interface that reflects specific facilities and equipment, the integrated and scalable Change Management Solution organizes and automatically tracks every element of a plant’s automation/software systems. It can greatly enhance plant production system usability, reliability, and accountability so that efficiency, responsiveness, and regulatory compliance are all assured. Change Management Solution also includes:
Multi-tier security. Control and monitor access to systems at all levels. Offering a second layer of security above the operating system security is necessary for Part-11 compliance. This solution ensures that system changes are introduced only by authorized people, and automatically records the identity of those making changes.
Electronic signature. Traceability of changes is a primary requirement for FDA-regulated companies. In addition to tracing changes, assuring changes are authorized is important. Change Management Solution allows configuration of electronic signatures at key points in the change operation. Before users can create a new version, they must be authorized to make those changes. Also, an authorized reviewer must authorize changes to make them a reality.
Automated audit trails. Track changes to applications and documentation. Another part-11 rule requires all system changes to be managed and tracked automatically to ensure full maintenance of electronic records, and to help prevent costly errors. With automatic checking in and out of files, only one authorized person can make changes at a time. Detailed reporting capabilities allow companies to view historical data in whatever format they require, and users can validate automatically that only approved versions of applications are running on devices.
Disaster Recovery. This capability lets companies restore their critical manufacturing PCs quickly. With single-boot-disk recovery, fast access to correct released versions, and data backed up automatically at one source, companies can recover in as quickly as 15 minutes from a failure, rather than a full day.
HTML interface and plant layout. This graphical plant layout lets users customize the interface to match individual plant needs. Point-and-click navigation makes accessing projects and devices simple, and provides a framework for remote troubleshooting. It also allows companies to give users access to only what they need, which reduces errors and training.
Control Engineering Daily News Desk
Jim Montague, news editor
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