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Complaints

Complaints

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Managing Complaints is not just a regulatory requirement but impacts the public image of your company, and CARA allows you to ensure that Complaints are quickly and automatically routed on workflows and escalations through to the resolution

Capturing Complaints

The configurable data forms in CARA provide an industry best-practice set of data fields for capturing Complaint information, but you can easily extend these to meet your specific process requirements.  This includes capturing root cause analysis, risk assessment, tagging to particular products, or relating to individual processes, including assigning responsible people and dates, and using these to trigger and monitor workflows

Tracking and resolving Complaints

Complaints are automatically related to the Quality Event and may result in related Change Requests.  You can also link documents that are related to the Complaint (e.g. product labels) from the associated Regulatory Documents in CARA.  Workflows and automatic escalations based on defined SLAs allow you to ensure that Complaint handling is kept on track.

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See where Deviations are linked with Events, Change Requests, and Quality Documents

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Metrics & Analytics

CARA provides an extensive dashboard and analytics capability, which allows management to track things like the response and resolution times of complaints.  All dashboards in CARA provide clickable graphs, which show you the items / documents that make up the data points on the graph.

 

Uniquely, CARA allows for geotagging of data such as complaints, so you can produce clickable heat maps by location, and spot clusters that might cross national borders but be proximate and thus of importance