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Module Highlights: Complaint Handling
The Complaint Handling module of
Grand Avenue Software manages the feedback of information from the
patient/clinic to the medical product producer and, where appropriate,
from the product producer to the FDA. The major work elements of the
Complaint Handling process include collecting and gathering product
feedback, proper categorization and determination of the feedback,
investigation activities when appropriate, and official reporting when
necessary. The Grand Avenue Software Complaint Handling module automates
and manages all these process phases and lifecycle activities.
Screen Capture: Complaint Handling
The Complaint Handling screen
capture highlights a complaint moving through the investigation and
reporting phases of the process. Investigators and researchers assigned
to the complaint record their results in the Activity Log. This
information is available for other people throughout the process as they
work on the complaint. Reporting tasks and assignments are managed by
geographical zone since reporting regulations vary from region to region.
The Complaint Handling
functionality available out-of-the-box from Grand Avenue Software
includes:
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Web-based submission of issues
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Review of issues to determine proper
disposition: Complaint, CAPA, Log as Issue
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Automated traceability between issues,
complaints and CAPAs
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Flexible investigation workflow with
activity log of research and evidence
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Tracking of reporting tasks and timelines
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Electronic creation of reporting forms
using Word templates
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Site-defined coding with custom parameters
for complaints
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Trending via charts and reports generated
based on coding values
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Workflow-driven due dates and reminders
based upon the overall schedule
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Flexible search of complaints and issues
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Integrated storage of issues, complaints,
documents, evidence, results, findings and reports
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