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| Complaint Handling - Capabilities and Benefits |
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Capabilities |
Benefits |
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Global Complaint Handling |
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Inherit Policies |
Ö |
Enforce standards by enabling sites to inherit corporate policies and workflows |
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Web-based Forms |
Ö |
Enable users from any department and off-site facilities to capture complaint data |
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Things-to-Do List |
Ö |
Keep your entire organization up-to-date on tasks and work items needing attention |
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Knowledge Management |
Ö |
Look up historical complaints and search for similar issues as a guide for resolving complaints |
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Improve Complaint Receiving & Recording |
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Configurable Web Forms |
Ö |
Easy-to-use Web forms enable all users to enter standardized complaint information |
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Integration
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Ö |
Automoatically exchange relevant complaint data with related systems |
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Samples and Product Returns |
Ö |
Easily track samples and product returns associated with a complaint |
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Unique IDs
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Ö |
Automatically assign a unique ID to FDA-submitted MedWatch 3500A forms for full traceability |
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Shorten Complaint Time-to-Resolution |
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Simple Resolution Model |
Ö |
Ensure rapid closure through automated receipt, review, reporting, resolution assignment and follow-up processes |
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CAPA-driven Resolution Model |
Ö |
Track investigations, causal analysis, resolutions and other activities to promote continuous improvement |
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Automated Alerting |
Ö |
Notify affected parties via e-mail to ensure prompt attention to complaints and resolution tasks |
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Escalation |
Ö |
Eliminate bottlenecks by automatically elevating
incomplete tasks |
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Root Cause Anlysis |
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Properly identify a problem's cause and determine the impact of a resolution to prevent future occurences |
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Activity Logs |
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Track all customer communication in a centralized location and reduce time to review actions & maintain verifiable evidence |
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Response Letters |
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Configurable Response Letter templates help automatically generate relevant communication to customers |
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Streamline Regulatory Submissions |
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Decision Trees |
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Based on industry requirements & SOPs, help you determine if a complaint report is required for a specific regulatory body |
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Auto-Populate Regulatory Forms |
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Reduce labor and error by automatically completing appropriate regulatory forms from complaints data |
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Global Support |
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Built-in regulatory forms for the medical device industry to support the FDA, Canada, EU, Australia and Japan |
| Tracking Submission Dates |
Ö |
Ensure timesly regulatory responses by identifying and tracking submission dates |
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Improve Management Oversight |
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Real-Time Reporting |
Ö |
Configurable resports provide instant visibility into complaints and issues to enable informed decision making |
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Trending |
Ö |
Identify, review and be knowledgeable about complaint trends on product and processes to improve customer satisfaction |
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Failure Mode Monitoring |
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Utilize your own failure modes in the system to set thresholds and know when trends emerge |
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