Centralize your quality management processes.

Easily manage FDA 21 CFR Part 211 compliance items with anyone, anywhere.

Automate workflow

QT9 QMS reduces staff time by eliminating manual processes.

Ensure FDA compliance

Meet FDA regulatory requirements for pharmaceuticals.

Connect & collaborate

Centrally upload, publish & distribute documents.

Meet CGMP regulations

Meet Current Good Manufacturing Practice (CGMP) with ease.

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See how QT9™ QMS stacks up against FDA 21 CFR Part 211 compliance.

The QT9 QMS is your all-in-one FDA 21 CFR 211 software solution.

Management Responsibility

QT9™ QMS Management Review Module

Subpart B 211.100

Quality Audit

QT9™ QMS Audit Management Module

Subpart B 211.22


QT9™ QMS Employee Training Module

Subpart B 211.25

Design Controls

QT9™ QMS Engineering Change Request Module

Subpart A 211.100

Document Controls

QT9™ QMS Document Control Module

Subpart D 211.22

Purchasing Controls

QT9™ QMS Supplier Evaluation Module

Subpart B 211.84

Production & Process Controls

QT9™ QMS Inspection Module

Subpart B 211.110

Measuring & Testing

QT9™ QMS Calibration Module

Subpart B 211.192

Nonconforming Products

QT9™ QMS Nonconforming Product Module

Subpart B 211.192

Corrective & Preventive Actions

QT9™ QMS Corrective Actions Module

Subpart A 211.22

Customer Complaint Files

QT9™ QMS Customer Feedback Module

Subpart B 211.192


QT9™ QMS Risk Assessment Module

Subpart B 211.192

Frequently Asked Questions: 21 CFR Part 211

What is 21 CFR Part 211?

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.

What is 21 CRF Part 210?

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.

Why is 21 CFR Part 211 Important?

The goal of 21 CFR Part 211 is to protect consumers by establishing a quality management system that pharmaceutical companies must follow to demonstrate the integrity of drug manufacturing from beginning to end. Being able to meet its standards is required for FDA approval, with the goal of assuring that “the drug products have the identity, strength, quality, and purity they purport.”

What are the key requirements of FDA CFR Part 211?

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
Is FDA 21 CFR Part 211 compliance mandatory?

Compliance with 21 CFR Part 211 is mandatory for pharmaceutical companies operating in the United States and is enforced by the FDA through inspections and audits of manufacturing facilities. Noncompliance can lead to severe consequences, including warning letters, product seizures, recalls, import bans and criminal charges.

How do I get started with FDA 21 CRF 211 compliance?

Quality Management System (QMS) software can streamline and centralize pharmaceutical compliance, improving quality and speeding delivery to consumers. QT9 QMS is a highly rated solution, with 23+ standard modules, including risk management, document control, employee training and audit management, backed by full customer support, an available ERP integration and Business Intelligence tool.

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Track all your FDA 21 CFR Part 211 information in one place.

QT9's easy-to-use 21 CFR 211 system makes pharmaceutical traceability and transparency simple.

Built-In Dashboard

Quickly see the status of CFR 211 items with real-time reports from the QT9 dashboard. You can even personalize the view specific to your needs.

Electronic Signatures

Make approvals electronically with electronic signature capturing built-in. QT9's user-friendly quality management system is FDA 21 CFR Part 11 compliant.

Software Validation

QT9 QMS is validated after each release, and it is in line with FDA QSRs to keep you in compliance with FDA quality system requirements.

QT9™ QMS is flexible for your business.

QT9 lets you choose modules based on what's best for your organization.

Modules for any business size

With multiple modules to choose from, there's solutions for nearly anyone.

A solution that scales with you

Whether you are a large corporation or a small start-up you can use as many modules as you want.

Cross-Platform Support

Whether you use Android, iOS or Windows, QT9 works from virtually any web browser.

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