Quality Events give you a way to capture everything that takes place in your business, planned or unplanned, that has to be managed for Quality – from audit findings to complaints, deviations and planned changes.
Capture all Quality-related items in an Event
CARA allows you to capture a wide variety of Quality Events: from Deviations and Customer Complaints to Audit findings, non-conformities, regulatory commitments, or other internal / external triggers. They are all handled using similar processes, with fields and workflows adapted to each type of event, but also allowing you to define your own events.
Link events to your QMS, RIM, and other parts of the platform
Once you have created events, you can link them to CAPAs as well as the Change Requests and the underlying documents. This gives you immediate traceability through the chain of linked data and documents.
Additionally, Quality Events can be used as triggers in the RIM module of the CARA Life Science platform e.g. to initiate new submissions, answers to HA questions, process renewals and Labelling updates.