Product Quality Review System (APQR)

AmpleLogic’s Product Quality Review System (APQR) is an AI-powered solution designed to automate and streamline the creation of Product Quality Review (PQR) and Continued Process Verification (CPV) reports. It helps pharmaceutical companies ensure compliance with global regulatory standards such as FDA 21 CFR 211.180(e), EU GMP, and others. The system integrates data from multiple departments and systems, enabling accurate, audit-ready documentation and continuous monitoring of product quality throughout the lifecycle.

Features

• AI-powered data visualization and analytics
• OCR-based data extraction from physical documents
• Integrated AI chatbot for quick data access
• Predefined templates for PQR and CPV reports
• Automated Batch Release Checklist
• Real-time dashboards and audit trails
• Configurable checklist templates aligned with SOPs
• Digital signatures and traceability across BMR, CAPA, and deviation records

Capabilities

• Automates annual product review processes across multiple sites
• Extracts and consolidates data from manufacturing, QC, and regulatory systems
• Flags recurring issues and trends for proactive resolution
• Manages batch release observations (minor, major, critical)
• Ensures complete documentation and compliance at every checkpoint
• Enables cross-functional collaboration for data validation and review
• Supports continuous monitoring of critical manufacturing parameters

Benefits

• Enhances audit readiness and regulatory compliance
• Reduces manual effort and documentation errors
• Accelerates batch release cycles and decision-making
• Improves data integrity and operational transparency
• Minimizes risk of product recalls and regulatory actions
• Enables proactive quality management and process optimization
• Saves time and cost through automation and intelligent workflows