CAQ.Net CAPA Software is a modular, cross-departmental quality management solution designed to monitor, control, and document Corrective and Preventive Actions (CAPA) throughout the entire product lifecycle. It supports compliance with GMP, ISO 13485, FDA 21 CFR 820, and other quality regulations, primarily in industries like medical devices. The software facilitates identification of root causes of quality defects by integrating data from supplier selection, incoming goods inspection, production, and complaint management. CAPA processes are assistant-supported and embedded across multiple modules, enabling initiation from various quality management areas such as gauge management, training, audits, or complaints. CAQ.Net also helps prevent CAPAs by enabling comprehensive quality system monitoring and control, emphasizing CAPA as a last-resort quality measure.

Key Features

Cross-Departmental CAPA Integration Enables CAPA initiation and management across multiple quality modules.

• CAPA process not a standalone module but integrated system-wide
• Trigger CAPA from gauge management, training, audit, complaint modules

Comprehensive Root Cause Analysis Identifies true causes of quality defects using consolidated product data.

• Access quality data from raw materials, production steps, personnel training
• Supports detailed cause-effect investigations

Lifecycle Quality Data Management Monitors and documents quality from product creation through complaint handling.

• Centralized access to all quality-relevant product data
• Supports PDCA (Plan-Do-Check-Act) cycle for continuous improvement

Information Transparency and Data Compatibility Eliminates manual and spreadsheet-based documentation to improve data integrity.

• Ensures consistent, compatible data across departments
• Facilitates effective CAPA system operation

Assistant-Supported Workflow Guides users step-by-step through CAPA initiation and management.

• Reduces complexity of CAPA processes
• Ensures compliance with regulatory requirements

Global and Modular Application Suitable for worldwide use with modular expansion for various quality facets.

• Adaptable to different industries and regulatory frameworks
• Modular design allows tailored quality management solutions

Benefits

Improved Quality Defect Resolution Faster and more accurate identification and elimination of root causes.

• Reduces recurrence of quality issues
• Enhances product and process reliability

Regulatory Compliance Support Helps meet GMP, ISO 13485, FDA 21 CFR 820, and other standards.

• Facilitates audit-proof documentation
• Supports global regulatory requirements

Enhanced Process Transparency Provides visibility into entire production and quality processes.

• Enables proactive quality control
• Supports decision-making with comprehensive data

Efficient Quality Management Streamlines CAPA workflows with integrated assistants and cross-module access.

• Saves time and reduces errors in CAPA handling
• Encourages cross-department collaboration

CAPA Prevention Capability Monitors quality system to minimize the need for CAPA initiation.

• Supports continuous improvement
• Treats CAPA as a last resort, not routine