Corrective and 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.
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.
Metrics & Analytics
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.
Capturing CAPA information
Tracking and resolving CAPA
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.
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.
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.
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Capture all Quality-related items in an Event
Link events to your QMS, RIM, and other parts of the platform
Capture all Quality-related items in an Event
Link events to your QMS, RIM, and other parts of the platform
CARA allows you to capture a wide variety of Quality Events: from Deviations and Customer Complaints to Audit findings, non-conformities, out of specifications, or other internal / external triggers. They are all handled using similar actions, with fields and workflows adapted to each type of event, but also allowing you to define your own processes.
Once you have created events, you can link them to CAPAs as well as the Change Controls and any underlying records. 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.
CARA allows you to capture a wide variety of Quality Events: from Deviations and Customer Complaints to Audit findings, non-conformities, out of specifications, or other internal / external triggers. They are all handled using similar actions, with fields and workflows adapted to each type of event, but also allowing you to define your own processes.
Once you have created events, you can link them to CAPAs as well as the Change Controls and any underlying records. 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.
