Quality Management System
Built for GMP Compliance and Manufacturing Excellence
Atachi QMS delivers built-in intelligence to capture documents, processes, and procedures with strict adherence to ICH Q10, cGMP, and FDA 21 CFR Part 11 guidelines. Complete quality management from API to finished products.
Schedule Your DemoWhy Atachi QMS?
End-to-end quality management with real-time integration, risk management, and continuous improvement built into every workflow
Regulatory Compliance Made Easy
Built on ICH Q10, cGMP, and FDA 21 CFR Part 11 guidelines with ICH Q7 for API manufacturers. Quality Risk Management (ICH Q9) is properly managed at every step.
- ICH Q10 pharmaceutical quality system
- ICH Q7 for API manufacturers
- ICH Q9 risk management controls
Real-Time Deviation Management
Integrate and monitor process deviations, environmental parameters, operational issues, and equipment deviations for immediate intelligent action.
- Automatic NCR creation
- Instant SMS/email alerts
- Deviation trending and analysis
Continuous Improvement
Improve processes, reduce waste, lower costs, and identify training opportunities through comprehensive quality analytics and performance tracking.
- Process optimization insights
- Training gap identification
- Quality trend analytics
Comprehensive Quality Management Capabilities
Everything you need to achieve quality excellence and maintain regulatory compliance
Sampling Plans
Regulate quality, manage deviations from stipulated quality parameters, and handle all quality-related issues with automated sampling plans and specifications.
Deviations Management
Monitor process deviations, environmental parameters, operational deviations, and equipment issues to take immediate intelligent action(s).
NCR and Alerts
Automatic creation of Non-Conformance Reports during deviations within set limits, with automatic SMS/email notifications to applicable personnel.
Operator Training & Certifications
Enforce certification requirements for process steps by separating roles with different certifications. Track training status and expiration dates.
Change Management
Comprehensive change control with review, approval, and execution workflows within groups and roles. Complete audit trail of all changes.
End-to-End Quality
Complete integration with PLC, ERP, and other systems to capture data in real-time. Seamless quality management across your entire operation.
Performance Analytics
Track quality metrics, identify trends, and make data-driven decisions. Comprehensive dashboards and reporting for management oversight.
Regulations & Compliance
Meet customer requirements and instill confidence in your organization. QMS implementation affects every aspect of organizational performance.
NGIMES Coverage for PQS (Pharmaceutical Quality System)
Comprehensive quality system coverage from facilities and equipment to personnel and processes
Perfect for Pharmaceutical & API Manufacturing
Built specifically for regulated industries with the strictest quality requirements
Pharmaceutical Manufacturing
Complete QMS built on ICH Q10 guidelines for pharmaceutical quality systems. Manage every aspect of quality from raw materials to finished products.
- Batch release management
- Quality control testing
- Regulatory compliance reporting
API Manufacturers
Strict adherence to ICH Q7 guidelines for Active Pharmaceutical Ingredient manufacturing with enhanced quality risk management at every production step.
- API quality specifications
- Process validation tracking
- Impurity profiling
Ready to Enhance Your Quality Management?
Learn how Atachi QMS can help you achieve regulatory compliance, operational excellence, and continuous improvement
Talk To Us Today About Your QMS Needs