TrackWise Digital can be leveraged to document the different investigational steps needed for compliant OOS management and how the different components interconnect to facilitate CAPA and follow up.
About Out of Specification (OOS)
Manage and trend nonconforming product, investigations and approval of resulting actions and product dispositions
Document and track results of in-process or finished product testing falling out of specified limits using OOS.
Leading Korean pharmaceutical manufacturer implements electronic quality management system to support growth, enable efficiency and data traceability.
The benefits of remote audits include lower costs, no travel restrictions, no logistical constraints, better use of resources and the ability to continuously monitor suppliers.