EtQ offers a version of its quality control platform designed specifically for medical device manufacturers.
Implementing a quality control software platform, especially at a large company, can be a daunting proposition. Platforms can be difficult to integrate with existing workflow, compliance, and business systems, and nonprogrammers can find some platforms difficult to use and customize. The quality control system for manufacturers from EtQ (Farmingdale, NY), however, overcomes these obstacles, says Tim Lozier, marketing manager.
“It's the most flexible system out there,” he says. “You can use it out of the box, it doesn't take long to configure or match existing processes, and you won't have to bring [program] developers in.”
Unlike systems that require programming for administrative actions, the EtQ system runs with graphical and keyword administration, and incorporates a drag-and-drop tool designed to simplify the interface. The company has also outlined a step-by-step process for implementation, which includes a preinstallation meeting between EtQ staff and customer staff, and postinstallation Web-based training support.
The company offers a version of the software tailored to the needs of medical device manufacturers. The platform is designed to achieve a high level of quality assurance through its event-filtering function. As product defects are reported, such events are automatically segregated and categorized. The events and corresponding corrective and preventative actions (CAPAs) are compiled in a database, and when a new problem arises, related CAPAs from the past can be consulted to see how similar problems were handled before.
The EtQ platform is designed to help manage risk and guide decision making. The filtering function puts incoming events in one of four categories, ranging from less critical (a cosmetic defect, for example) to highly critical (a severe functional defect). Companies can then pinpoint the events that need immediate attention. The software platform also features an investigation function with step-by-step root-cause analysis. Using this function, companies can reduce the number of CAPAs by up to 400%, Lozier says.
The platform's connector modules can close the gap between production systems and the quality system. For example, the nonconforming material returns module and the complaints module can connect to enterprise resource planning systems and customer relationship managing systems to fully automate the creation and assignment of events. Production systems can then be automatically updated throughout the event resolution process, such as triggering the release of products based on the material review board disposition, or updating the complaint status based on investigation results.
As required by CFR Part 11, medical device companies must maintain a secure electronic environment, and the system must be validated to maintain electronic signature integrity. EtQ's Web-based system of validation is designed specificially for the medical device industry, and the company's staff has developed test scripts with the aim of easing system validation. Because the EtQ software is usable out of the box and configurations are executed at the server level, the system is unique in how little validation across the enterprise is necessary, according to the company.
The system also continues to change with the times. As the process for FDA submission of medical device reports and quality system data continues to evolve, the company is working with regulators to connect the EtQ platform to the planned electronic FDA submissions system.