My current role dealing with engineering change controls involved document control and properly maintaining records of changes in manufacturing of medical device and pharmaceutical products. This information is used for regulatory filings, quality control, health authority filings, and audits. The best way to ensure that the information is properly recorded and maintained is to have an efficient system in place with an established directive for different scenarios, that outlines how to record the changes. Currently our workflow utilizes Trackwise which is a electronic system that is used for initiating, monitoring, and maintaining both change controls and investigations that are launched into products. We are in the process of creating a new workflow with another system, in which we are working on tackling the problems that cause delays and errors in documentation.