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Module Highlights: Corrective and
Preventive Action (CAPA)
Each software module in the suite
is built around proven best practices. The best practices reflect years
of experience on the front lines regarding what works and what doesn’t
work in actual medical products companies. The core of each practice is
a business process that serves as the backbone for the functional
capability. The CAPA process as implemented in the Grand Avenue Software
solution is shown in the Screen Capture: CAPA Solution.
Screen Capture: CAPA Solution
This screen highlights the
overall CAPA process, the process signature history and a link to the
detailed data audit trail. Grand Avenue Software automates each set of
user activities that need to occur within each box or process step. As
each step gets completed, the software moves the work package
automatically to the next step in the process. The system notifies
people of the work they have to do, presents all the information they
need to do the job, and provides instructions on how to get the job
done. People don’t have to worry about what they need to do and when.
The system gives users assignments via an inbox and via email with
corresponding due dates and reminders.
The CAPA functionality available
out-of-the-box from Grand Avenue Software includes:
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Web-based submission of CAPA requests
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Integrated solution for corrective, preventive and continuous improvement requests
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Early review of request to determine
validity as a CAPA
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Immediate prioritization and backlog
management
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Detailed root-cause management and action
planning
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Formal review of proposed action plans
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Tracking of individual actions and
verification of effectiveness
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Optional long-term verification and
follow-on actions
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Workflow-driven due dates and reminders
based upon the implementation schedule
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Flexible searching of CAPAs
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Integrated storage of requests, documents,
markups, evidence, results and verification data
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Up-to-date charts/reports of status and
trends
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