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.
This is according to Daniel Coetzee, Business Manager Sub-Saharan Africa for GE Fanuc Automation, a division of the GE Infrastructure global business platform.
"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," Coetzee maintains.
"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," he adds.
According to Coetzee, based on Cimplicity Manager software, the new GE Fanuc Proficy 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," Coetzee advises.
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," he says.
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," points out Coetzee.
The GE Fanuc Proficy Change Management System includes:
Francesco Della Rosa