Corrective & Preventive Actions
Corrective & Preventive Actions
Once you have created a Quality Event, you can tackle the process of correcting it and preventing it, using the CAPA process within the CARA Life Science Platform.
Capturing CAPA information
The configurable data forms in CARA provide an industry best-practice set of data fields for capturing CAPA 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 CAPA
CAPA are automatically related to the Quality Event and may result in related Change Controls. You can also link documents that require modifying to the CAPA, or create new actions required for the CAPA implementation. Automations ensure that CAPA cannot be closed before associated Change Controls are completed, and once CAPAs are closed, the parent Quality Events can then also be resolved and evaluated for effectiveness.
See where CAPAs 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 resolution times of CAPA and other metrics. All dashboards in CARA provide clickable graphs, which show you the items or documents that make up the data points on the graph.