The Only ERP That Arrives Pre-Validated for Pharma and Biotech
Manage batch production, quality, traceability and compliance in one validated system.
FDA 21 CFR Part 210 & 211
FDA 21 CFR Part 11
ICH Q10
GxP / cGMP
Pre-Validated ERP, No Internal CSV Required
QT9 ERP arrives fully validated — IQ/OQ/PQ included — so your team can focus on manufacturing, not documentation. Built-in support for 21 CFR Part 11, with audit trails and electronic signatures ready on day one.
- Faster Implementation: Validation documentation included, not a separate project
- Reduced Compliance Burden: No internal CSV effort required
- 21 CFR Part 11 Support: Electronic signatures and audit trails built in
Batch Records, Quality Records and Master Data are Automatically Maintained
- Electronic Batch Records: Built in real time from production activity.
- Quality Records: Connected across deviations, CAPA, change control and training.
- Master Data: Formulas, specifications and approved process data stay aligned with active operations.
When Quality and Operations Share a Brain, Everything Changes
Standard
How QT9 ERP Addresses It
FDA 21 CFR Parts 210 & 211
Production controls, batch traceability, inventory management, quality oversight and recordkeeping in one connected system
FDA 21 CFR Part 11
Secure electronic signatures, audit trails and validation documentation included
ICH Q10
Integrated pharmaceutical quality workflows that support lifecycle management, continual improvement and risk-based quality processes
GxP / cGMP
Controlled workflows for materials, manufacturing, quality events, training and change management across regulated operations
Data Integrity
Real-time records, role-based access, audit history and controlled approvals across critical workflows
Estimate Your Hidden Cost of Poor Quality
What Is Poor Quality Costing Your Business Each Year?
Answer a few quick questions to estimate the potential annual cost of scrap, rework, holds, supplier issues, and investigation delays.
Complete all inputs to unlock your estimated annual COPQ (0/7)
See What Industry Leaders Say About QT9 ERP
“The system has proven to be intuitive and easy to navigate. The customer service team has been exceptional, assisting us in setting up the platform to ensure full compliance with our processes.”
Hira S. | Nanz Pharma
Capterra Review
"QT9 has proven to be an invaluable asset for our quality management needs. Its versatility, ease of use, and robust features have significantly streamlined our processes, reduced the potential for errors, and enhanced our overall efficiency. "
Archana C. | QA Manager | Pharmaceuticals
Capterra Review
"Being an FDA regulated and ISO 13485 manufacturer, the integration between QT9's ERP and QMS is a huge advantage for us as well, providing full traceability and direct integration between our operations and our quality system."
John S. | President | Medical Devices
Capterra Review
Ready to Eliminate Validation Delays and Quality Gaps?
Book a 30-Minute Demo with a Pharma ERP Specialist.