QMS Software for 21 CFR Parts 210 & 211 Compliance
Modernize your pharmaceutical quality system with QT9. Meet FDA requirements with real-time traceability, batch control and audit-ready records.
Automated Document Control
Securely manage SOPs and specifications protocols with version control and 21 CFR Part 11-compliant electronic signatures.
Electronic Batch Records
Digitize batch records and ensure all production and quality data is captured, time-stamped and ready for FDA audits.
Nonconformance Management
Identify, track and resolve nonconformances in real time, ensuring root cause analysis and CAPA follow-ups are documented and traceable.
Change Management
Control and document every change to processes, equipment and documents to meet cGMP expectations for accountability.
QT9 QMS helps you stay compliant with 21 CFR Parts 210 and 211
QT9 QMS software is purpose-built to help pharmaceutical and life science manufacturers comply with the FDA’s Current Good Manufacturing Practices (cGMP) under 21 CFR Parts 210 and 211.
QT9’s cloud-based platform automates and streamlines these requirements, giving you complete traceability, compliant electronic signatures, secure audit trails and real-time reporting.
Explore how FDA 21 CFR Part 210/211 software can benefit your organization
Simplify compliance with current Good Manufacturing Practices (cGMP)
Ensure audit readiness at all times
Digitize and streamline batch record management
Capture, track and review all batch production and quality data electronically, improving traceability and eliminating manual errors.
Improve visibility across quality and manufacturing
Accelerate employee training and qualification
Strengthen supplier and material controls
Manage supplier approvals, monitor incoming materials and link supplier data to production batches for end-to-end traceability and quality assurance.
See how QT9 QMS stacks up against FDA 21 CFR Parts 210 and 211 compliance
QT9 QMS is your all-in-one FDA 21 CFR 210 and 211 software solution.
Management Responsibility
QT9 QMS Management Review Module
Design Control
QT9 QMS Product Design Control Module & Engineering Change Request Module
Purchasing Controls
QT9 QMS Supplier Evaluation Module
Production & Process Controls
QT9 QMS Inspection Module
Nonconforming Products
QT9 QMS Nonconforming Product Module
Corrective & Preventive Actions
QT9 QMS Corrective Actions Module
Customer Complaint Files
QT9 QMS Customer Feedback Module
FAQ: 21 CFR Part 210/211 Compliance
21 CFR Part 211 is a common way to refer to the U.S. Food and Drug Administration (FDA) Code of Federal Regulations Title 21, Part 211: Current Good Manufacturing Practice for Finished Pharmaceuticals. Also known as cGMP, it is the primary standard outlining the steps for meeting minimum good manufacturing practice (GMP) standards for finished pharmaceuticals in the United States.
FDA 21 CFR Part 210 is used in conjunction with Part 211. Where Part 211 focuses on process control for finished pharmaceuticals, Part 210 outlines minimum standards for manufacturing, facilities and controls.
Meeting the FDA standards for pharmaceutical manufacturing is a complex endeavor, but the major elements involve:
- Qualifications and skills of personnel
- Equipment and facilities maintenance
- Control of components, product containers and closures
- Production and process controls
- Packaging and labeling controls
- Warehousing and distribution
- Laboratory controls
- Records and reports
- Returned and salvaged drug handling procedures
QT9 QMS provides built-in tools for managing SOPs, training, deviations, CAPAs, batch documentation and audits, which are all aligned with FDA requirements. It supports electronic signatures and audit trails for 21 CFR Part 11 compliance, which is critical for electronic records used to meet 210/211 standards.
Yes. QT9 QMS is fully compliant with 21 CFR Part 11, supporting secure electronic signatures, time-stamped audit trails and user access controls. This ensures electronic records used for 21 CFR Part 210/211 are legally trustworthy and inspection-ready.
Yes. QT9 QMS integrates with QT9 ERP or QT9 MRP for seamless alignment between quality processes and production activities. This supports batch-level traceability, materials tracking and change control, essential for FDA-compliant pharmaceutical manufacturing.
QT9 QMS centralizes your documentation, training records, batch data and CAPAs in one secure system. With advanced filtering, exportable reports and full audit trails, you can instantly retrieve all required documentation to support an FDA inspection or internal audit.
Yes. QT9 QMS is built for multi-location organizations, offering role-based access, centralized dashboards and scalable compliance processes across manufacturing sites or global operations.
Pre-validated QMS software
QT9 QMS is pre-validated for accelerated compliance.
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FDA and ISO compliance out-of-the-box
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Rapid cloud deployment for faster implementation
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Audit-ready with timeline traceability
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Electronic signature approvals and secure access controls
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Continuous validation and updates
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• ISO 13585 |
• FDA 21 CFR Part 11 |
QT9 QMS includes a complete execution of all protocols, including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).
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Eliminates costly internal QMS validation efforts that can take months of staff time or cost thousands in consultant fees.
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Reduces downtime waiting for your QMS to be approved for use.
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Minimizes the risk of any failed audits due to flawed validation protocols.
Unlimited Support Included
Have a question? QT9 support is here to help for all QT9 QMS users.
Explore QT9 quality management resources
QMS Software Validation: Ensuring FDA, ISO and Industry Compliance
From Concept to Market: FDA Approval Process for Medical Devices
Data Integrity: A Critical Component of FDA and ISO 13485 Compliance
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