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.
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.”