Fluke Biomedical, a medical device organisation, has chosen the MasterControl Suite to automate its document control and training record management processes
Fluke Biomedical is a manufacturer of quality biomedical test and simulation products and a provider of the latest medical imaging and oncology quality-assurance solutions for regulatory compliance.
Fluke is the world leader in compact, professional electronic test tools.
Fluke customers are technicians, engineers, electricians and metrologists who install, troubleshoot and manage industrial electrical, biomedical and electronic equipment and calibration processes for quality control.
The MasterControl Suite will be deployed in Fluke Biomedical's Cleveland and Seattle locations.
Fluke Biomedical is currently implementing and receiving training on the system.
"We chose MasterControl to improve the effectiveness of our documentation control program and our regulatory administration," says John Nelson, Fluke Biomedical's QA regulatory manager.
"The MasterControl Suite is FDA-compliant and allows us to integrate training management with document management, which is an important goal for us.
"It will also provide a way to better manage our resources and improve efficiency in the quality assurance department.
"Additionally, we wanted a system that would allow us to move from a client server process to a web-based system.
"I looked a MasterControl competitor but it didn't offer the benefits MasterControl provides," Nelson says.
"I've installed MasterControl at another company and was impressed with the ease of use, great training and fantastic customer support I received.
"Choosing MasterControl to meet Fluke's needs was an easy decision to make".
MasterControl's integrated compliance software solution allows life sciences companies to meet and exceed strict FDA requirements, but hundreds of companies also use the software for compliance with ISO standards, Sarbanes-Oxley Act, and similar regulations.
MasterControl facilitates compliance management by automating and managing document and change control, training management, audits, corrective/preventive action (Capa), customer complaints, nonconformance disposition, deviation handling, electronic batch record (EBR) management, and other GxP processes critical to regulatory compliance.
