Technical Services for Electronics Selects MasterControl to Facilitate FDA, ISO Compliance
SALT LAKE CITY Jan. 3, 2007 MasterControl Inc. today announced that Technical Services for Electronics (TSE), a leading contract manufacturer for medical device, communications, and test instrumentation industries, has selected the MasterControl software solution to help facilitate compliance with FDA regulations and ISO standards.
TSE is an FDA-registered and ISO-certified contract manufacturer with more than 34 years of experience in technical design and customized interconnection (cabling, electronic connectors) solutions. The company's solutions for the medical device industry include safety leads and adapters, implantable lead interface, and pacemaker interface.
?We want to automate our manual processes that are arduous and entail a lot of paperwork to keep track of. We want to be able to control documents electronically in a manner that is both FDA and ISO compliant,? said Ben Custalow, network administrator for TSE.
The company, which has facilities in Minnesota, Taiwan, and China, evaluated five software solutions before choosing MasterControl. ?The main reason we chose MasterControl is because it possesses good workflow and electronic form capability, as well as a high-quality document control solution. These capabilities are crucial to the automation of our ECN [engineering change notice] process, which is our most cumbersome and painful process,? said Custalow.
TSE is certified to ISO 9001:2000 and ISO 13485:2003. As part of its compliance efforts, the company has ongoing internal audits. The company chose MasterControl Documents and MasterControl Forms? as the foundation of its Web-based quality management system. TSE will be performing its own software validation using MasterControl's IQ/OQ protocols. ?We hope to be able to process as many of our forms electronically as possible. The net effect will be an increase in efficiency, which will provide a company-wide cost savings, and at the same time maintaining our FDA and ISO compliance,? said Custalow.