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 CATSWeb® Complaints Management & Regulatory Reporting
Overview
The CATSWeb Complaints Management & Regulatory Reporting system provides a best practices process for managing the entire event lifecycle from event intake through investigation, root cause analysis and reporting to regulatory agencies.
A comprehensive solution, CATSWeb Complaints Management & Regulatory Reporting system offers the following key features that are built-in, right out of the box:
Business Performance Metrics – Monitoring / Management Visibility
 Management dashboards to easily monitor status and performance at any level; the entire enterprise, division, functional area, or department
- Reports based on real-time performance metrics for trends, cycle times and costing
- Drill down capability in all reports to view the source data and navigate to individual records
- Management reports on trend elements (products, problems, cause codes, cost codes) by department, function, division, corporation
- Activity cycle time (response, resolution, planning, implementation times) reports that trend by month, quarter, year
 Best Practice Workflows
- End-to-end workflow for processing all events intake, reportable and non-reportable
- Additional unlimited best practices workflows may be added
- Point-and-click modification of template workflows by process owner
- Workflow version control and change management
- Workflow ownership by group, department, role, employee (one or more)
Integration with other Processes
- Integrate to other quality processes (audits, CAPAs, issue tracking, change management)
- Cross query any selected process by any field element (product, problem type, cause code, etc.)
- Enterprise reports broken out by function, department, division or on whole enterprise across integrated processes
Audit Trail, Electronic Signatures
- Audit trail and electronic signature compliant to the FDA's 21 CFR Part 11, includes a secure, time-stamped archive
- Audit trail on file attachment modifications
- Query on audit trail
- View edit changes on the form in the audit trail showing the before/after field values
- View changes on entire record, not just the fields
- Electronic signatures cannot be modified, copied, transferred or deleted
- Accommodate signatures comments
- Manage proxy signatures allowing user to designate backup approvers
Reportablity Evaluation & Regulatory Reports
- Decision-tree processing to automate the evaluation of reporting
 requirements for the US FDA, Canada, Europe, and Australia.
- Automatically manage report due dates and notify assignees when tasks become due and past due
- Generate MedWatch 3500A and other vigilance reports in PDF format
- Generate follow-up/supplemental reports based on changes to previously submitted reports
Task Lists, Notification, Escalation, Reminders
- Easily manage your workload through a list of assigned tasks and approval requests on your home page
- Department tasks and approval request listed on supervisor’s home page
- Reminder and escalation rules are all user-defined
- Users are automatically notified of task assignments, reassignments, pending and late tasks based on rules
- Process owners may also be notified of task milestones and approval accomplishments based upon user-defined criteria
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eMDR - Electronic Medical Device Reporting: Read the update
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CATSWeb Complaints Management and Regulatory Reporting provides a best practices approach to the entire event lifecycle.
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Built-in performance and monitoring metrics allow management to view real-time reports for trends, cycle times and costing.
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Form 3500A FDA approved.
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Audit trails and electronic signatures provide compliance with the FDA's 21 CFR Part 11 requirements.
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Generate Medwatch, supplemental and other international regulatory reports.
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Manage tasks with notifications, escalations, rules and reminders.
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"Executive dashboards — One of the tenets of an enterprise approach to complaint management is that the solution should provide visibility to key managers and executives responsible for the compliance.
Rather than generating a report from time to time, we recommend executive "dashboarding" to provide up-to-the-minute information on complaint-related activities. This includes different views, based on organizational roles and the ability to drill down within the application."
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