Process Validation Software

AmpleLogic’s Process Validation Software is a comprehensive AI-powered solution designed for regulated industries such as pharmaceuticals, life sciences, cosmetics, food & beverages, and medical devices. It enables organizations to validate complex manufacturing processes with precision, ensuring compliance with global standards like FDA 21 CFR Part 11 and GAMP 5. The system automates protocol creation, data collection, analysis, and reporting, while integrating seamlessly with ERP, QMS, and APQR systems to enhance operational transparency, efficiency, and regulatory readiness.

Features

• Auto protocol drafting based on SOPs
• Electronic signatures for secure approvals
• Real-time monitoring of process parameters
• Audit trail for tracking system changes and activities
• Smart validation reporting with data visualization
• Version control for documents and procedures
• Training and competency record management
• Integration with lab equipment like HPLC and balances
• Verification of resources before usage
• Workflow automation for approvals and data entry

Capabilities

• Protocol management with customizable templates
• Document management for SOPs, batch records, and reports
• Data collection and analysis from diverse sources
• Change control with evaluation and documentation
• Risk assessment and mitigation planning
• Compliance assurance with regulatory standards
• Version Master Plan automation
• User-friendly interface for simplified operations

Benefits

• Ensures process accuracy and regulatory compliance
• Reduces manual effort and documentation errors
• Improves audit readiness and data integrity
• Enhances operational efficiency and transparency
• Supports continuous improvement and risk management
• Accelerates validation cycles and decision-making
• Facilitates seamless integration with enterprise systems