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Investigate Issues Early

Manage Quality Events with Ease

Capture, track and resolve quality events to improve compliance and reduce risk.

Capture Quality Events

Log deviations, incidents and nonconformances with ease.

Secure Event Database

Store all event details in one searchable, compliant hub.

Auto Risk Prioritization

Score events automatically to highlight the most critical.

Fast CAPA Launch

Trigger corrective actions instantly from quality incidents.

Regulatory Confidence

Maintain full traceability to meet ISO, FDA and GMP standards.

Analyze Event Trends

Use dashboards to spot patterns and prevent repeat issues.

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What is Quality Event Management Software?

Quality event management is the process of capturing, assessing and resolving unexpected quality issues, such as deviations, incidents, and process failures, that can impact product safety, compliance or operational performance. This process is essential in regulated industries like life sciences, manufacturing, and food and beverage production, where ISO 9001, FDA 21 CFR Part 11 and GMP standards require organizations to document and address quality-related events promptly and consistently.

QT9’s quality events software gives organizations a centralized system to track and manage all quality events in real time. From initial event logging and risk scoring to corrective actions and approvals, every step is streamlined and traceable. Fully integrated with the QT9 QMS, it connects seamlessly with modules like CAPA, audits and customer complaints, helping businesses improve compliance, reduce risk and drive continuous improvement across operations.

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QT9 QMS Quality Events Demo
Quality Events SL Screenshot

QT9 QMS Quality Events Demo

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QT9 QMS is a Fully-Validated Platform

We do all the software validation for you. No extra charge.

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Centralize Quality Events

  • Closed-loop quality event management: Create, track and trend quality event investigations and outcomes in one place.

  • Connect quality events: Quality Events serves as your central hub to quality issues that can create corrective actions, nonconforming products, customer feedback and even deviations.  

  • Eliminate data silos: Work together in one system for accurate traceability and compliance. 

  • Manage custom fields: Create unlimited user-defined fields and save your best practices for the future.

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Capture End-to-End Quality Event Management

  • Record any event affecting your quality system: Enable your team to investigate, delegate tasks, attach files, tag types and categories for trend analysis, and link to other modules in QT9 QMS.

  • Assign categories: Organize quality events with your own types, categories and dispositions. 

  • Manage workflows: Route action items to the right person with automated reminders. 

  • Standardize quality event processes: Consistently track quality events the same way to ensure no information gets missed. 

Quality-Event-Management-Software-Categories

Track and Trend Quality Events

  • Real-time reporting: Keep pace with trends in quality events for better decision-making.

  • See quality events your way: Make it easy to see the most relevant information for your team by creating multiple custom views within quality events. 

  • Stay on track: Reduce delays with automation efficiencies, such as email alerts and electronic signature approvals.

Quality-Event-Management-Software-Reports

Integrate your Quality Events

Create a shared hub for collaboration.

Improve Collaboration

Link quality events to customers, suppliers, processes and products.

Improve Collaboration

Manage Tasks

Assign responsibilities, set deadlines and track progress.

Manage Tasks

Responsible Party

Pre-assign approvers and create responsible parties.

Responsible Party

Improve Traceability

See a timeline of every action along with lot and serial traceability.

Improve Traceability

Get Real-Time Analytics

Make informed decisions with real-time dashboards. Create your own custom views.
Get Real-Time Analytics

Ensure Compliance

Show proof of proper handling, supporting FDA Current Good Manufacturing Practices (cGMP).

Ensure Compliance

Initiate Investigations

Launch and explore evaluations and investigations. Assign dispositions and track verification notes.

Initiate Investigations

Link Files

Tackle quality events together by sharing files attachments to keep everyone on the same page. 

Link Files
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 Find Out Where Your Quality Program Stands 

 Two free tools to quantify your cost of poor quality and stress-test your traceability — no demo required. 

See what Quality Leaders say about QT9 QMS

“I love that QT9 is an all-encompassing suite of modules that covers every part of my QMS. We maintain an ISO9001:2015 certification, and this program will take the place of countless spreadsheets and emails.”
Sara Cutigni
APR Allen Plastics
“Easy to use and helps to organize information across our company. I like that you can easily load in tasks and reminders. Also, you can see who in the group still needs to complete something.”
Bill Ranous
Fulton
“QT9 QMS Software is a gamechanger for my organization. Implementation of the software was easy and quick. The customer support was unmatched. ”
Tara Buchanan
Torrent Photonics

Get End-to-End Quality Management

    FAQ: Quality Events

    What is a quality event?

    A quality event is part of a quality management system used to identify any departure from an expected behavior that could effect quality. This could be anything from an incorrect temperature recording to a customer complaint.

    What is the quality event process?

    Every quality event is different, but having a standardized process to follow helps ensure no task is overlooked. The general framework to address a quality event involves collecting basic information about the incident, assessing level of risk, initiating an investigation if so warranted, and documenting each step for compliance and future trend analysis. The QT9 QMS Quality Events Module standardizes the process and automatically documents processes for easier tracking and traceability.

    What software is used for quality management and quality event tracking?
    QT9 Quality Management System (QMS) software is used by process and discrete manufacturers to manage quality and compliance in a closed-loop digital system. It supports in-line quality processes, clear reporting, and straightforward audit tracking, helping organizations meet strict industry and customer requirements.
    What is quality event management, and how does QT9 support it?
    Quality Event Management (QEM) is an extension of a Quality Management System that focuses on managing specific quality-related events such as nonconformances, deviations, complaints, and incidents. While a QMS manages quality processes holistically, QT9 QEM helps organizations capture, track, and resolve quality events efficiently within the broader QMS framework.

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