BACKGROUND

OPPORTUNITY

Moving from Manual to Digital Processes 
TMS like many organizations today, was challenged with manual and paper-based quality management processes. Furthermore, these processes were often disconnected and did not support the desired level of accountability. They acknowledged that this disconnected and outdated approach to qualitymanagement posed increased regulatory compliance risk to the organization.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..

SOLUTION

A Comprehensive Framework for Quality Management with TrackWise Digital
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 EQMS and Complaint Handling solution with mobile capabilities. The TrackWise Digital Quality and Complaint Management Systems manages 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.

RESULT

A Robust, Scalable System that Alleviated Key Challenges
The TrackWise Digital team 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. TrackWise Digital 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.

Topcon has improved process visibility by being able to track tasks, due dates and escalations . With the system’s robust reporting, the data and insights will drive continuous operational efficiencies. By implementing a leading solution, Topcon has leveled the paying field with larger companies in the industry.

QUICK FACTS

Topcon Medical Systems

• Industry: Medical Device
• Distribution: Global
• Employees: 4,900+
• Solution: TrackWise Digital