FDA 21 CFR Part 11-Compliance Made Easy
Easily meet FDA electronic approval requirements with QT9™ QMS and QT9™ ERP.
Complete Audit Trail
QT9 QMS maintains a secure, time- and user-stamped audit trail for all quality records, with QT9 ERP supporting traceable operational data.
Electronic Signatures
QT9 QMS enables compliant electronic signatures for record approvals, supported by QT9 ERP for connected operational workflows.
Integrated Digital Environment
QT9 QMS centralizes electronic quality records, while QT9 ERP reduces reliance on paper by connecting manufacturing and business processes.
Secure Access Control
QT9 QMS enforces controlled system access, with QT9 ERP supporting role-based permissions across operational functions.
Modernize your processes with electronic approvals
Capture FDA 21 CFR Part 11-compliant signatures electronically with anyone, anywhere.
Explore how 21 CFR Part 11 compliance software can benefit your organization
Enhance operating efficiency
Simplify 21 CFR Part 11 compliance
Streamline audits and inspections
Simplify internal and external audits by automating scheduling, tracking, and reporting compliance data in one central place.
Reduce waste and costs
Increase customer satisfaction
See how QT9 QMS and QT9 ERP stack up against FDA 21 CFR Part 11
QT9 is available in the cloud or on-premise
Flexible deployment to match your IT strategy without compromising security or speed.
Work smarter with intelligent automation in quality and compliance
QT9 Software’s built-in automation streamlines compliance workflows, quality checks, and alerts, reducing human errors, accelerating decision-making and freeing your team to focus on higher-value work.
Speed up implementation with pre-validated software
QT9 Software offers a fully pre-validated environment, with every module and feature tested and documented for compliance. Save time, avoid costly internal validation processes and go live faster with confidence.
Ensure audit-ready traceability across all processes
Track every action, change and event in real time with QT9 Software. Timeline-based traceability supports inspections, audits and product recalls by providing complete visibility into your processes and product history.
Empower teams with secure, self-service portals
QT9 Software provides dedicated web portals for employees, suppliers and customers, enabling secure self-service access to documentation and data while streamlining collaboration across your organization.
Catch and resolve issues instantly with real-time monitoring
Monitor operations live with real-time dashboards and automated alerts using QT9 Software. Enable proactive responses to nonconformances, minimize downtime and improve compliance outcomes across your organization.
Onboard faster with an intuitive, user-friendly platform
Whether you’re a startup or an enterprise, QT9 Software’s clean, intuitive interface minimizes the learning curve, empowering users to work confidently, complete tasks accurately and stay audit-ready from day one.
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 13485 |
• 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.
FAQ: FDA 21 CFR Part 11
21 CFR Part 11 is a U.S. Food and Drug Administration (FDA) regulation that outlines criteria for the use of electronic records and electronic signatures, as well as when they are “considered equivalent to paper records and handwritten signatures executed on paper.” The regulation’s intent is to ensure the integrity and security of electronic records and signatures.
Organizations that are regulated by the FDA or supply related products and/or services need to comply with 21 CFR Part 11. The most common of these industries include, pharmaceuticals, biotechnology, medical devices, clinical labs, food and beverage manufacturers, and cosmetic manufacturers.
For FDA-regulated companies, 21 CFR Part 11 compliance is mandatory, but it should not be considered a burden.
The goal of 21 CFR Part 11 is to allow businesses to use digital technology while ensuring the integrity and security of electronic records. Companies gain multiple efficiencies by adopting digital technologies and automating record-keeping and approval processes. Benefits include reducing margin of error, speeding document routing and approval, creating an automatic audit trail with easy trackability and traceability, and minimizing the risk of using outdated documentation.
FDA 21 CFR Part 11 has three subparts:
- General Provisions
- Electronic Records
- Electronic Signatures
General requirements in Subpart B cover:
- System validation
- Readable records
- Document storage and record retention
- System access controls
- Audit trails
- Workflows
- Authorized user checks
- Device checks
- Personnel qualifications
- Personnel accountability
- Document control
Requirements for Subpart C cover:
- Identity verification
- Security controls
- Use of logins and passwords
For more detailed information visit https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
With QT9 QMS, all of your document and record management is automated, including the ability to capture 21 CFR Part 11-compliant signatures. Our cloud-based platform makes electronic records and FDA-compliant signatures possible from any device, anywhere, at any time.
With more than 25 modules that come standard, QT9 QMS streamlines quality processes and regulatory compliance with powerful scalability and efficiency. We are a highly rated system, loved by customers. Reach out today for more information.
Several QMS software providers offer 21 CFR Part 11 compliance-ready platforms, including QT9 QMS, MasterControl and ComplianceQuest.
QT9 QMS is designed with built-in Part 11 compliance features, such as secure electronic signatures, detailed audit trails and validated system controls, helping companies meet FDA requirements with confidence.
The best QMS software for FDA-regulated companies is one that:
- Offers a pre-validated environment, saving users time and speeding adoption
- Enables audit-ready traceability across all processes
- Provides real-time visibility for faster response to nonconformances
- Automates and integrates compliance workflows, quality checks and alerts
- Has an intuitive, user-friendly platform
QT9 QMS is a top choice for FDA-regulated companies because it offers validated compliance with 21 CFR parts 11, 210-211 and 820 (QSR, QMSR). QT9’s cloud-based platform, modular structure and seamless integration with QT9 ERP make it ideal for medical device, pharmaceutical and nutraceutical manufacturers who need both compliance assurance and operational efficiency.
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