Following controlled processes is a regulatory requirement to ensure Quality remains high – tracking and managing Deviations from this process is therefore a key part of your QMS
Capturing Deviation details
The configurable data forms in CARA provide an industry best-practice set of data fields for capturing Deviation information, but you can easily extend these to meet your specific process requirements. All Deviation items allow attachment of supporting documentation or other items to give you a quick way to access all information related to the Deviation
Tracking and resolving deviations
Quality Events for Deviations are tracked and resolved by creating linked CAPA items, which may result in Change Requests and the updates to underlying documents. This gives you immediate to track the resolution of Deviations through the linked data and documents, and ensure that you can plan preventive measures to avoid recurrence of the Deviations.
Metrics & Analytics
CARA provides an extensive dashboard and analytics capability, which allows management to track things like the resolution times of deviations, the numbers of deviations per country / site / product over a particular time period, or other metrics. All dashboards in CARA provide clickable graphs, which show you the items / documents that make up the data points on the graph.