TraTek is a precision manufacturer of screws, plates and instruments used in orthopaedic surgery. It has manufacturing facilities in Indiana and Costa Rica that are both certified to ISO 13485, a quality management system standard for the design and manufacture of medical devices. 

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Complying with ISO 13485 required TraTek to maintain a large volume of records. But as Luke Bulino, General Manager, explains, it meant the company’s quality management system (QMS) was generating a lot of paper. “It was quickly burying us. We had a strong desire to get an automated system,” he says. In addition to streamlining operations with paperless records that were instantly available and securely backed-up, TraTek needed the chosen QMS solution to help maintain its ISO 13485 certification. With two manufacturing facilities, one outside the US, it needed to provide users with secure, role-based access to records from anywhere in the world. Bulino was also keen on a hosted system to reduce upfront costs and the need for IT support. “I previously worked for a company that had a good QMS, but its efficiency was greatly hindered by the software used, which was slow and required a lot of extra work to make the data helpful.”

Entropy met all TraTek’s needs – and more. The system facilitates a streamlined, process-based approach to quality and compliance management by first creating an action, then notifying the relevant people, tracking due dates, allocating responsibility, defining task dependencies, performing root-cause analysis, and ultimately escalating results or issues to management when necessary. Entropy serves as the main repository for ISO 13485-related records. Through configurable access approval and reporting privileges, the web-based system enables authorized users in both Costa Rica and Indiana to have convenient, but controlled, access to secure records.

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Entropy’s reporting feature makes it easy for Bulino and his managers to provide auditors with reports on demand, such as control procedures, audit schedules, management reviews and internal audit scorecards. “The reporting capabilities really streamline the auditing process,” says Bulino. In addition, he adds, most of TraTek’s goals are process-based, so the ability to make revisions to control documents quickly and easily has helped the company achieve those targets. Other uses of the system include improving and adding to records that the company maintains, such as raw materials certificates, device histories and training logs. “Entropy is able to grow with the business, so it’s a good fit for a young, maturing company like TraTek,” concludes Bulino. “It has definitely made us a more efficient organization and brought us a positive return on our investment.”