adWATCH - CAPA

adWATCH - CAPA, developed by Atlant Systems, is a corrective and preventive action management system designed to help organizations capture, distribute, retrieve, and manage quality issues globally and in real-time. It is primarily aimed at pharmaceutical and medical device companies that need to handle CAPA requests from multiple sources — including customers, physicians, patients, distributors, and internal locations — while meeting company and regulatory requirements.

The system supports collaborative document creation, review, and approval among individuals both inside and outside the organization, across multiple sites worldwide. Quality issues can originate from any manual or computer source or application, including in-process inspection, receiving inspection, finished goods, and material review boards.

Core Capabilities

• Receives, reviews, and evaluates quality issues and corrective/preventive action requests from customers, physicians, patients, distributors, and other internal or external organizations.
• Processes and documents investigations of quality issues by the relevant manufacturing site or sites.
• Resolves quality issues by managing the corrective and preventive actions required to meet customer service goals.
• Tracks all open quality issues to ensure timely resolution and action.
• Enforces an approval process for each CAPA entry that complies with both company and regulatory requirements.
• Provides access to the CAPA management system for all authorized users inside and outside the organization.
• Archives CAPA and related documents electronically for rapid search and retrieval.
• Delivers ad hoc reporting to management for trend evaluation and statistical analysis.

Features

• Accepts corrective and preventive action requests from product complaint systems as well as a company's ERP system.
• Allows remote users to participate in system functions via dial-up, intranet, or extranet connections.
• Mirrors the full CAPA workflow from initial notification through investigation, analysis, and resolution.
• Supports timely responses to quality issues related to products, assemblies, sub-assemblies, and raw materials, with customer feedback capabilities.
• Includes a software validation database to assist with FDA-mandated requirements for initial validation and change control procedures.
• Enterprise-wide replication keeps information current across all locations worldwide.

adWATCH - CAPA is built to operate across distributed, global environments and integrates with existing complaint management and ERP systems. Its software validation database is specifically designed to support compliance with FDA requirements for validation and change control.