Quality Management (QMS)
Traceability across the business
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 your event records, you can assign and implement containment actions, perform risk assessments, and begin investigations, before planning and approving your CAPA actions and Change Controls. Throughout the process you can link each record to the corresponding items, be it a registration, manufacturer, or product. This gives you immediate traceability through the chain of linked data and documents.
Additionally, Quality Events can be used as triggers in RIM on the CARA Life Sciences Platform to initiate new submissions, answers to HA questions, process renewals and Labelling updates.
How it works
1. Define Event
Capture and track all data relating to the event, use workflows to QC the data here and for all subsequent steps
2. Link to Affected Products
Link the Event to products, so that from the RIM modules you can easily trace which products have Quality Events associated with them
3. Initial Assessment & Approval
Perform an initial assessment including risk analysis, justification, and notification procedure, allowing authorities and customers alike to stay informed
4. Root Cause Analysis
Undertake investigation, capturing iterative comments and notes and attaching documentation evidence or supporting documents, until you have a Root Cause specified
5. Effectiveness Check
When the event is closed, you can monitor it and run periodic Effectiveness Checks to ensure that the problem was fixed – otherwise you can reopen the event and use all the data and documents captured so far to adjust the implementation of the remediation
6. Risk Assessment
Capture information on the possible risks of the CAPA implementation, and have CARA calculate the overall risk factor, to then allow you to define risk management and priorities
7. CAPAs & Change Controls
Associate CAPAs and Change Controls to the Quality Event to then be able to trace through the chain of quality activities and information, as well as the underlying records
Quality events
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.
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.
Change controls
Having a Change Control mechanism that is seamlessly connected to every part of the CARA Life Science Platform (Quality, Regulatory, Safety and Clinical) is a true differentiator and brings large business value to you, with a true enterprise view of your business activities
Deviations
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
Complaints
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
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