Topcon Medical Systems (TMS), based in Oakland, NJ, is a leading developer and supplier of diagnostic equipment for the ophthalmic community. For over 40 years TMS has been leading the way with the most technically advanced instrumentation in the marketplace. Their product line comprises the largest selection of precision instruments from one manufacturer...providing products for a wide range of applications, including imaging, diagnostic, refractive, surgical, and delivery. Topcon Medical Systems is a wholly owned subsidiary of Topcon Corporation of Tokyo, Japan.
TMS like many organizations today, was challenged with manual and paper-based quality management processes. Furthermore, these process were often disconnected and did not support the desired level of accountability. They acknowledged that this disconnected and outdated approach to quality management posed increased regulatory compliance risk to the organization. Prior to TrackWise Digital, the company received customer complaints through their field service channel or call center, which used Salesforce to capture the information. As expected, with disparate systems being used for various quality processes, TMS was challenged by manual and duplicate data entry and was struggling under mountains of paper and silos of data. This made it difficult to assign, manage and track quality process tasks and lead to a lack of continuity between processes, poor visibility and an inability to effectively conduct trending analysis.
TMS was focused on leveraging technology to improve their quality management process with a specific focus on complaints and corrective and preventative actions (CAPA).
Solution and Implementation
TMS was initially interested in the fact that the TrackWise Digital solution is built on the Salesforce App Cloud. This complimented their existing approach using Salesforce.com to capture cases. Topcon needed a system that supported the full lifecycle of activities that a closed loop regulatory system should. During vendor selection Topcon was able to quickly realize that by utilizing TrackWise Digital within the Salesforce cloud they could fold several disparate processes and systems into one cohesive integrated platform. The TrackWise Digital solution provided a comprehensive framework for complaint handling and quality management. Topcon implemented the full TrackWise Digital QMS and Complaint Handling solutions. The TrackWise Digital Quality and Complaint Management Systems manage their processes in accordance with FDA and ISO regulations from initiation through further investigation, root cause analysis and final quality approval. In addition, they both are fully compliant with 21 CFR Part 11 including full audit trail and electronic signature functionality.
Sparta Systems partnered with Topcon Medical Systems and quickly built a strong relationship, ensuring the TrackWise Digital implementation, training and adoption would be handled and delivered as expected. In addition, Topcon was able to take advantage of the validation package to help reduce the overall implementation time.
Sparta Systems TrackWise Digital solutions provided a robust, scalable solution that solved all of the pain points that Topcon needed to address and more. As a result of the system capabilities, Topcon is noticing record handling times reduced by almost 30% and an almost 35% increase in productivity.
TMS now has the desired process visibility and can track tasks, due dates and escalation requirements. Moreover, Topcon is armed with the reporting to generate insight from data and use that insight to further improve operations. Lastly, Topcon implemented a leading solution that helps even the playing field with larger companies in the industry.