QMS Software Manufacturing Manufacturing QMS Software
Manufacturing Quality Management Software for Operational Excellence
Connect your quality processes across production lines, suppliers and locations, all in one easy-to-use platform.


A QMS designed with manufacturers in mind
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Automate document control with version tracking
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Simplify CAPA workflows from start to finish
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Centralize audits, training and equipment calibration
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Link suppliers to quality events for better visibility
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View real-time analytics and KPIs on customizable dashboards
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Choose from cloud or on-premise deployment options
Key features for manufacturing operations
Document Control
Automated version control, approval routings and e-signatures.
CAPA Management
Easily document issues, assign actions and identify root causes with integrated tools.
Audit Management
Plan, execute and document internal and external audits with checklists and workflows.
Quality KPI Dashboards
See real-time performance with charts and reports for NCs, CAPAs, audit scores and supplier ratings.
Supplier Management
Evaluate, track and view supplier performance in real time.
Change Management
Nonconformance Reporting
Quickly log and manage nonconformances, with risk assessments and escalation.
Employee Training
Ensure all operators are qualified with auto-updated training matrices and certification tracking.
Equipment Calibration
Maintain up-to-date maintenance and calibration records for all tools and production assets.
Embed ISO 9001 Quality Principles into Every Manufacturing Process
- Define quality objectives by department
- Link CAPA & NCs to ISO 9001 clauses
- Automate internal audit programs
- Monitor QMS effectiveness via KPIs
Integrate ISO 14001 Environmental Controls Across Sites
- Track emissions, waste, and resource use
- Map environmental objectives to processes
- Route environmental audits & assessments
Trace Products from Raw Material Through Final Assembly
- Link raw materials to subcomponents & final units
- Enable recalls or holds confidently
- View full history per finished item
Ensure Equipment Accuracy with Ongoing Calibration Control
- Schedule calibration & preventive tasks
- Lock equipment during maintenance
- Record results with eSignatures
- Connect maintenance to quality events
Manage Process Updates and Revisions via Controlled Workflow
- Issue ECN/ECO with audit trail
- Route change requests for approval
- Link changes to impacted items
- Retain full version history
Evaluate and Control Supplier Quality and Incoming Parts
- Qualify, audit, and score suppliers
- Capture deviations on receipt
- Automate supplier corrective actions
- Link parts to supplier performance
More than 1,000 customers worldwide






FAQ: Manufacturing QMS
Most industries are subject to some form of industry or government regulation to protect end users or the general public interest. In tightly regulated industries, such as medical device or automotive manufacturing, quality controls are mandated by national and international standards and regulations. Being able to consistently demonstrate quality is a legal requirement that, if not followed, could have legal, monetary and, potentially, life-altering consequences.
Good quality management benefits manufacturers in many other ways as well. The quality of the goods and services you manufacture can make your business stand out in a crowded, competitive marketplace. Being able to maintain quality on a consistent basis earns repeat business. A good quality management system (QMS) can help you avoid recalls, use resources effectively and save money.
A manufacturing quality management software is a comprehensive platform that streamlines business processes focused on ensuring product/service quality that meets or exceeds customer requirements.
Most manufacturers continue to use paper-based quality management systems, and a quality management software could save many of these organization hundreds of hours of time each year and tens of thousands of dollars in costs. By eliminating the need to manually update multiple systems and spreadsheets opens up opportunities to gather more real-time data and consistency across organization’s locations, departments and people.
Quality management software (eQMS) centralizes, streamlines and integrates quality management tasks and documentation, organizing them and making it easier to meet regulatory and industry standards. eQMS software is typically cloud-based, making it accessible anytime or anywhere, enabling users to collaborate and streamline information anywhere.
If you’re striving to achieve ISO, FDA or other regulatory compliance, or if you would like to improve efficiency for overall performance and bottom-line success, QMS software can help.
Some of the benefits of adopting QMS software include:
Better, easier document control: Automating document control with QMS software means no more paper logs or lost email approvals. Approvals are tracked electronically with a timeline that gives you to full traceability.
Audit prep: Documentation needed for regulatory compliance is automatically generated, tracked and stored through its lifecycle. Many QMS software solutions have embedded processes for meeting strict regulatory standards.
Built-in efficiencies: QMS software automatically generates next steps in your quality processes with interconnected applications, so tasks like risk assessments and supplier reviews are automatically generated. Users can also take advantage of useful aids, such as to-do lists, email reminders and automatic scheduling.
Real-time data: QMS software provides the most up-to-date data surrounding your quality operations – from the status of calibrations to supplier evaluations. With a centralized, automated system, the latest data is always at your fingertips, ensuring decisions are made based on the most up-to-date information.
Stay ahead of competitors: With QMS software, quality becomes ingrained in your operations and efficiencies are reached throughout your organization, allowing you to bring your products to market more quickly. Saving time and money can put you ahead of your competitors.
With more than 25 modules that come standard, QT9 QMS excels at all of the processes that you need for managing manufacturing quality, including:
- Document Control
- Inspections
- Audit Management
- Nonconforming Products
- Corrective Actions
- Supplier Management
- Management Review
- Continuous Improvement
- Customer Feedback
QT9 QMS is a highly rated, easy-to-use quality management system based in the cloud for ultimate collaboration and connection. QT9 QMS offers unlimited scalability and traceability, full customer support, an ERP integration and Business Intelligence tool to help visualize and make informed decisions in real time.
Several cloud-based quality management systems are available, each serving different industries and compliance needs. Leading options include QT9 QMS, MasterControl, ETQ Reliance, Veeva and Greenlight Guru.
QT9 stands out as one of the few QMS platforms ready out-of-the-box with 25+ modules for centralizing quality and compliance metrics with a single, fully validated platform. Plus, QT9 QMS seamlessly integrates with its ERP system, providing a single solution for both quality and business operations.
When evaluating cloud-based QMS platforms, companies should compare overall and added features, including support for FDA 21 CFR and ISO compliance, document control, audit management and ease of integration.
Switching to QT9 QMS is a simple process with guided onboarding and data migration tools. The most common challenges include organizing historical records, training employees and aligning existing processes with digital workflows.
Common challenges companies experience when moving from manual or legacy systems include:
- Organizing historical quality records
- Training employees on standardized digital workflows
- Ensuring alignment between existing processes and the automated modules
- Reconfiguring workflows to meet compliance requirements
With guided onboarding, training resources and our award-winning customer support, QT9 works to minimize these challenges so customers can achieve faster adoption and smoother transition.
Solutions By FDA Standard
FDA 21 CFR Part 11
Explore FDA 21 CFR Part 11 QMS Software
FDA 21 CFR Part 211
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FDA 21 CFR Part 820
Explore FDA 21 CFR Part 820 QMS Software
FDA Compliance
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Solutions By Regulatory Standard
AS9100
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HACCP
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IATF 16949
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SQF
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Trusted by manufacturing companies
The software is outstanding, the support is quick, and thorough. Intuitive, friendly user interface, the well thought out connections from one module to another. The fact that each module is included and not ala carte is a HUGE benefit. The online training academy is one of the best I have used.
Capterra - Mid-Market (501-1000 emp.)
Overall it's a very good platform for a company who needs to jump into a one-stop QMS solution. The product is easy to implement because of the built-in world class workflows. You can focus on how to *use* the software, and not spend valuable time trying to *configure* it.
Capterra - Mid-Market (201-500 emp.)
We are a tiny manufacturing company. Recent audits for a large and valuable customer have driven the need to develop our Quality Management System. QT9 was the only reasonably priced option that didn't make me pick upfront which handful of modules I might need.
Capterra - Small Business (51-200 emp.)
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