Complaint Handling - Capabilities and Benefits

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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, engineering collaboration, 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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