SOFTWARE MANAGES PRODUCTION CHANGES TO HELP ACHIEVE 21 CFR PART 11 AND GMP COMPLIANCE
12 August 2004 - GE Fanuc Automation CNC Europe SA

Echternach, Luxembourg – GE Fanuc has introduced a new Change Management solution which helps life sciences companies track changes and control versions of automation software, devices and equipment used on the factory floor. This provides a framework to achieve 21 CFR Part 11 and GMP compliance.

One of the most challenging issues for manufacturers in the life sciences is the FDA's requirements for electronic records as defined in regulation 21 CFR Part 11 and its impact on controllers and other production device programs. In addition to helping companies achieve compliance, this proven solution can also help users protect against plant downtime due to device failures and operator errors.

Based on CIMPLICITY Manager software, the new GE Fanuc ProficyÔ Change Management System 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, with an open architecture, can connect to an installed base of disparate plant floor systems.

Now available, Proficy Change Management has been installed and proven at pharmaceutical companies that have been audited and validated by the FDA. Based on existing pharmaceutical applications, GE Fanuc offers a measurable, near-term ROI from increased plant uptime, improved engineering processes, reduced engineering and maintenance costs, and lower capital expenses.

With a user-configurable interface that reflects specific facilities and equipment, the integrated and scalable Proficy Change Management System organises 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. The GE Fanuc Proficy Change Management System includes:

Multi-Tier Security - Controls and monitors 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 authorised 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 authorised is important. The Proficy Change Management System allows configuration of electronic signatures at key points in the change operation. Before users can create a new version, they must be authorised to make those changes. Furthermore, an authorised reviewer must authorise changes to make them a reality.

Automated Audit Trails - Tracks changes to applications and documentation. Another part-11 requirement, all system changes are 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 authorised 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 – The solution's Disaster Recovery 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 a single source, companies can recover in as quickly as 15 minutes from a failure, not a full day.

HTML interface and plant layout. The graphical plant layout lets a user customise the interface to match individual plant needs: point-and-click ease of use makes accessing projects and devices simple and provides a framework for remote troubleshooting. It also allows companies to give users access only to what they need, thus reducing errors and training.

http://gefanuc-europe.com

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