adWATCH - PCM

adWATCH – PCM (Product Complaint Management) is a system developed by Atlant Systems for capturing, distributing, retrieving, and managing product complaints on a global, real-time basis. It is designed for pharmaceutical and medical device companies, supporting complaint intake from manual sources, computer systems, and external applications. The system enables document creation, review, and approval to be conducted collaboratively among users both inside and outside the organization, across multiple locations worldwide.

adWATCH – PCM addresses the full lifecycle of a product complaint, from initial receipt through investigation and final resolution, while supporting compliance with both company-level and regulatory requirements.

Core Complaint Management Capabilities

• Receives, reviews, and evaluates product complaints from customers, physicians, patients, distributors, and other organizations
• Processes and documents investigations of product complaints at the respective manufacturing site or sites
• Resolves product complaints and manages the actions required to meet customer service goals
• Tracks all open product complaints to ensure timely resolution and follow-up action
• Enforces an approval process for each complaint that complies with company and regulatory requirements
• Provides access to the complaint management system for all authorized users inside and outside the organization
• Archives product complaint documents electronically to support rapid search and retrieval
• Delivers ad hoc reporting to management for trend evaluation and statistical analysis

Features and Benefits

• Automatically generates FDA-approved MedWatch, Baseline, and CIOMS reports from data already stored in the database
• Supports remote user participation in system functions via dial-up, intranet, or extranet connections
• Mirrors the workflow of complaint processing from initial notification through investigation, analysis, and resolution
• Includes a Customer Notification forms letter library that allows customized letters to be sent at predetermined times or on an as-needed basis during investigation and resolution
• Provides the ability to respond quickly to product quality issues by delivering timely customer feedback
• Includes a software validation database to assist with FDA-mandated requirements for initial validation and change control procedures
• Enterprise-wide replication ensures up-to-the-minute information is available across all locations worldwide
• Designed with an interface intended to be straightforward for end users

adWATCH – PCM supports deployment across distributed, global organizations through enterprise-wide replication and remote access options. The system includes built-in tools to assist with regulatory compliance, including automated regulatory report generation and a dedicated software validation database for change control management.