Solutions
SmartComplaints - Enterprise-wide Complaints Management Solution for Regulatory Compliance
By
Jul 30, 2005, 19:49

Complaint handling is a critical part of any quality and regulatory compliance program. Powered by Pilgrim’s CAPA Management platform, Pilgrim’s Complaint Management provides a closed-loop mechanism that allows you to implement effective, timely resolutions to customer issues. This helps you ensure industry and regulatory compliance, improve product quality and reduce costs associated with customer complaints.


Improve Complaint Receiving & Recording

Pilgrim’s Complaint Management’s configurable, easy-to-use Web form allows you to capture complaint information across your entire organization, including off-site personnel, such as field services representatives. Complaints can also be received through integration with third party applications, such as Customer Relationship Management (CRM) systems, or from customers and suppliers via your corporate Web site. Pilgrim’s Complaint Management provides you with the ability to capture complete information about a complaint, including customer information, product identification criteria, sample returns, and complaint type (such as inquiries). Pilgrim’s Complaint Management enables you to make rapid, informed decisions about complaint validity and resolution strategies.

Complaint Creation Screen - click here to enlarge

Shorten Complaint Time-to-Resolution

With configurable workflow models built on industry Best Practices, Pilgrim’s Complaint Management streamlines the entire complaint resolution lifecycle – from complaint capture to investigation through resolution (whether simple or full CAPAs) and to customer communications. Pilgrim’s Complaint Management enables you to standardize complaint handling processes across the organization and manage deviations and incidents in real-time so you can quickly identify resolution strategies and take fast action to resolve problems. E-mail notifications, commitment tracking and escalation capabilities help to eliminate bottlenecks and ensure rapid resolution. Pilgrim’s Complaint Management offers a proven means to manage complete customer communication with activity logs and customer letters stored in a single, centralized solution.

Complaint Detail - click here to enlarge

Streamline Regulatory Submissions

Pilgrim’s Complaint Management allows you to review complaints and streamline the submission and tracking of reports to the appropriate regulatory body. The standard automated decision trees, which are also configurable, assist in medical device reportability reviews for the FDA, EU, Canada, Japan and Australia. Pilgrim’s Complaint Management includes all associated medical device regulatory forms including MedWatch, Baseline, EU MDV, Canada TPP, Australia TGA, and Japan ARR.

Regulatory Submissions - click here to enlarge

Regulatory Requirements and Validation

With role-based document securities, powerful password authentication, a complete audit trail and an easy, automated validation process, Pilgrim’s Complaint Management helps you facilitate compliance with requirements for electronic signature, electronic records and software validation such as 21 CFR Part 11 from the FDA. Pilgrim’s Complaint Management meets internal and industry standards and regulatory requirements including FDA, cGxP, ISO 9000, ISO 13485, ISO 14000, ISO 14971, Sarbanes-Oxley sections 404 and 302, EU directives, International Health Ministries.

Medwatch Form - click here to enlarge

Through powerful reporting and trending capabilities, Pilgrim’s Complaint Management provides fast, accurate information to help management make meaningful and effective decisions. Built-in, configurable reporting capabilities enable management to drill-down into issues and offer valuable insight into the top recurring complaints and time required to resolve issues.

Decision Tree - click here to enlarge

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.

For an overview of capabilities and benefits, click here.