From PilgrimSoftware.com
Complaint Handling - Capabilities and Benefits
By
Oct 26, 2005,
11:31
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Capabilities |
Benefits |
|
Global Complaint Handling |
|
Inherit Policies |
Ö |
Enforce standards by enabling sites to inherit corporate policies and workflows |
|
Web-based Forms |
Ö |
Enable users from any department and off-site facilities to capture complaint data |
|
Things-to-Do List |
Ö |
Keep your entire organization up-to-date on tasks and work items needing attention |
|
Knowledge Management |
Ö |
Look up historical complaints and search for similar issues as a guide for resolving complaints |
|
Improve Complaint Receiving & Recording |
|
Configurable Web Forms |
Ö |
Easy-to-use Web forms enable all users to enter standardized complaint information |
|
Integration
|
Ö |
Automoatically exchange relevant complaint data with related systems |
|
Samples and Product Returns |
Ö |
Easily track samples and product returns associated with a complaint |
|
Unique IDs
|
Ö |
Automatically assign a unique ID to FDA-submitted MedWatch 3500A forms for full traceability |
|
|
Shorten Complaint Time-to-Resolution |
|
Simple Resolution Model |
Ö |
Ensure rapid closure through automated receipt, review, reporting, resolution assignment and follow-up processes |
|
CAPA-driven Resolution Model |
Ö |
Track investigations, causal analysis, resolutions and other activities to promote continuous improvement |
|
Automated Alerting |
Ö |
Notify affected parties via e-mail to ensure prompt attention to complaints and resolution tasks |
|
Escalation |
Ö |
Eliminate bottlenecks by automatically elevating
incomplete tasks |
|
Root Cause Anlysis |
Ö |
Properly identify a problem's cause and determine the impact of a resolution to prevent future occurences |
|
Activity Logs |
Ö |
Track all customer communication in a centralized location and reduce time to review actions & maintain verifiable evidence |
|
Response Letters |
Ö |
Configurable Response Letter templates help automatically generate relevant communication to customers |
|
Streamline Regulatory Submissions |
|
Decision Trees |
Ö |
Based on industry requirements & SOPs, help you determine if a complaint report is required for a specific regulatory body |
|
Auto-Populate Regulatory Forms |
Ö |
Reduce labor and error by automatically completing appropriate regulatory forms from complaints data |
|
Global Support |
Ö |
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 |
|
Improve Management Oversight |
|
Real-Time Reporting |
Ö |
Configurable resports provide instant visibility into complaints and issues to enable informed decision making |
|
Trending |
Ö |
Identify, review and be knowledgeable about complaint trends on product and processes to improve customer satisfaction |
|
Failure Mode Monitoring |
Ö |
Utilize your own failure modes in the system to set thresholds and know when trends emerge |
The Integrated Compliance Platform
Pilgrim’s SmartComplaints is a fully-integrated part of the Pilgrim Software’s Enterprise
Compliance and Quality Platform. Pilgrim Software provides an
enterprise–wide solution for managing corrective and preventive actions, complaint handling, change control management, internal and external audits, document control, SOP enforcement, employee certification and training, equipment/calibration, supplier quality management, advanced quality planning and risk management.
This powerful solution enables you to manage quality and compliance
across your entire business, helping you meet regulatory requirements,
increase efficiency and reduce costs.
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by Pilgrim Software