Case Studies
Case I
A multinational medical device company needed a standard approach to conducting investigations. PathWise worked with team members to identify gaps in their current investigation process and created a global Root Cause Investigation training program. The project required 18 months and included the critical issues of CAPA, complaints, and NCR investigations. The end result was a 30% decrease in repeat investigations, Root Cause identified in less time with fewer people, and final CAPA reports that could stand alone against FDA scrutiny.
Case II
A small medical device company was having issues within their quality system, working one-on-one with the FDA on a monthly basis for over a year. They were a start-up operation with an excellent product, but were having trouble sustaining systems while growing in head count. PathWise was able to work with this manufacturer to audit and recommend improvements in their current system. Our consultants were able to identify their problems, offer workable solutions, and implemented a new system that would comply with the FDA. After a few months of refining and solving all of the FDA findings, the manufacturer was able to re-launch their product on the market and continue to grow.
Through training in PathWise Project Success managers learned a process for the selection and approval of projects. Team leaders and team members acquired the skills to accomplish projects on time and within scope.
© 2012 Pathwise - All Rights Reserved
