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Nonconformance Management Software

Accelerate Nonconformance Processes for Improved Oversight

Reduce nonconformance management cycle times while increasing control and visibility over every quality issue reported. Our AI powered nonconformance software helps eliminate process inefficiencies by automating workflows, ensuring regulatory compliance, and providing real-time insights that empower your team to investigate and resolve issues faster.

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Nonconformance Reporting Software
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Qualityze

Intelligent QAI Assistant to Simplify Nonconformance Investigations

Detect patterns and predict issues before they escalate with our QAI assistant that provides real-time insights and automates routine tasks for faster resolutions like root cause analysis, suggests corrective actions, and recommends next-steps to accelerate your nonconformance workflows, ensuring timely resolutions.

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Nonconformance in Quality Management

Save Administrative Load with Standardized NC Templates

Before any nonconformance event can be identified and managed, it's essential to have the right templates in place. Qualityze Nonconformance Management allows you to configure NC templates for standardized repeatable processes tailored to your unique business needs—whether for specific products, processes, systems, or workflows. These templates serve as a blueprint, ensuring consistency across all nonconformance events. It further helps to save on administrative time and load.

Deviation Management Software

Ensure Timely Nonconformance Event(s) Reporting

Effective nonconformance management starts with timely identification and reporting of nonconformance events. Our robust solution enables you to efficiently capture every detail —including defect codes, root causes, process specifics, manufacturing, supplier, and customer information—into one centralized system. This proactive step not only ensures accountability but also demonstrates your commitment to maintaining high-quality standards.

Nonconformance Reporting and Management

Segregation for “Immediate Remediation”

After a nonconformance is reported, the Containment step ensures the issue is isolated to prevent further impact. This involves production delays, segregating defective products or processes, and implementing short-term corrective actions to minimize risks. The system comes with an in-built risk matrix. It generates a Risk Priority Number to help you with prioritizing the high-risk events without delays.

Nonconformance Tracking System

Minimize Risks with Rapid Disposal of Defective Products

The disposition step prevents compromised goods from reaching customers or going further into production. With Qualityze, you can document the lot numbers, quantities, and reasons for disposal to maintain compliance and ensure traceability. It facilitates collaboration with relevant teams and suppliers through instant notifications to ensure that every impacted product is properly accounted for, minimizing risks and maintaining the integrity of the supply chain.

How to Reduce Nonconformances in Manufacturing

Fast-Track Resolution with Root Cause Investigation

The next step is a thorough investigation to identify its root cause. This involves gathering data and using structures methods like 5 Whys, or 5 How's. Standardized defect codes and categorization help streamline the evaluation, ensuring that high risk severity issues are prioritized. Proper documentation of this phase is essential for compliance and future audits, aligning with industry best practices in nonconformance workflows.

Nonconformance Management Software for Manufacturing

Drive Continuous Improvements with Tailored Action Plans

After identifying the root cause, the action plan is designed to correct the issue and prevent recurrence. It assigns clear tasks to relevant teams with deadlines, ensuring prompt execution. Implementing the plan involves tracking progress and verifying effectiveness. Continuous monitoring and documentation ensure compliance and drive long-term improvements across the organization, resolving the nonconformance efficiently.

Nonconformance Management Software for Manufacturing

Escalate to CAPA for Proactive Quality Control

This step involves evaluating the severity and frequency of the problem to determine if corrective actions are required to address the immediate issue and preventive actions to mitigate future risks. CAPA ensures long-term solutions are implemented, preventing recurrence and enhancing overall process effectiveness. Proper documentation and analysis are critical to justify CAPA and maintain compliance with regulatory standards.

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What Differentiates Us from Others  We have got you covered for everything you look for in a next generation nonconformance management solution to be future-ready!

  •  End-to-End Nonconformance Control

    Unlike others nonconformance tracking systems, our solution offers complete end-to-end management of nonconformance events, from detection to resolution. With real-time tracking, integrated root cause analysis, and automated workflows, we ensure that every nonconformance issue is addressed with precision and speed.

  •  Configurable to Fit Your Needs

    We understand that every business has unique processes. That’s why our platform is fully configurable, allowing you to tailor workflows, templates, and defect codes to align with your specific industry requirements—whether in manufacturing, healthcare, or beyond.

  •  Built-In Compliance Tools

    Compliance is at the core of what we do. Our solution is designed to meet strict regulatory requirements like ISO, FDA, and GxP. We provide built-in compliance checks, audit-ready reporting, and traceable workflows, ensuring you're always prepared for inspections or audits.

  •  AI-Powered Insights

    What sets us apart is our AI-driven intelligence. Our software not only tracks nonconformance events but also uses AI to predict trends, recommend corrective actions, and continuously improve processes, helping you stay ahead of potential issues.

  •  Seamless Integration

    Integration is key in today’s digital landscape. Our platform seamlessly integrates with your existing systems (ERP, CRM, and more), ensuring a unified approach to quality management. This reduces data silos, increases visibility, and enhances collaboration across teams.

  •  User-Friendly Interface

    While other systems may be complex and difficult to navigate, our platform offers an intuitive, user-friendly interface that requires minimal training. This ease of use ensures quick adoption by your team, reducing downtime and accelerating results.

  •  Continuous Improvement Culture

    We not only help you fix problems; we help you prevent them. By providing actionable insights and tracking nonconformance trends, our software promotes a culture of continuous improvement, driving long-term operational excellence.

  •  Unparalleled Support and Training

    What truly differentiates us is our commitment to your success. We offer ongoing training, personalized support, and regular updates to ensure that your nonconformance management processes are always optimized and aligned with industry best practices.

Industry Recognitions

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Qualityze Delivering Value Across Key Roles

Discover how Qualityze Nonconformance Management empowers every key role in managing NCs for seamless collaboration and success —from quality managers to regulatory affair manager.

For Quality Manager

Qualityze gives you complete visibility and control over the nonconformance process, from identification to resolution. The software automates workflows, tracks corrective actions, and ensures compliance with industry standards like ISO and FDA. By streamlining nonconformance management, you can focus on driving continuous improvement while ensuring that quality and regulatory requirements are consistently met.

For Production Manager

With Qualityze, you can address production-related nonconformance issues without halting operations. The software provides real-time visibility into defects, automates root cause analysis, and implements corrective actions quickly. You’ll be able to minimize downtime, reduce rework, and ensure that production continues smoothly while maintaining high-quality standards.

For Quality Control/Quality Assurance (QC/QA) Technicians

Qualityze simplifies the process of identifying and documenting nonconformances during inspections or audits. With easy-to-use forms, defect categorization, and automated workflows, you can escalate issues quickly and ensure they’re resolved efficiently. The software empowers you to stay ahead of quality risks while reducing manual documentation tasks.

For Root Cause Analysis Specialists

Qualityze provides powerful tools like root cause analysis, defect code management, and integrated reporting, allowing you to investigate nonconformance events with precision. Whether using 5 Whys or Fishbone Diagrams, the software helps you get to the root cause faster, ensuring that corrective actions target the actual issue and prevent future occurrences.

For CAPA Coordinator

Qualityze enables you to easily manage and monitor all Corrective and Preventive Actions (CAPA). The software automates task assignments, tracks completion, and verifies the effectiveness of actions, ensuring full compliance with regulatory requirements. By streamlining CAPA workflows, you can ensure timely resolutions and drive continuous improvement initiatives.

For Regulatory Affairs Manager

Qualityze ensures that your nonconformance processes are always compliant with FDA, ISO, and other regulatory standards. The software provides audit-ready documentation, tracks corrective actions, and ensures that all nonconformance events are properly addressed. You can stay audit-prepared while minimizing the risk of regulatory fines or compliance issues.

Experience the Qualityze Difference to Manage Nonconformances with a free demo. Here’s what you’ll get to see in the demo:

We understand that choosing the right nonconformance software is a big decision. That’s why we invite you to experience Qualityze for yourself with a free demo. Here are three compelling reasons to take us up on this offer:

  • See AI-Powered Nonconformance Management in Action

    Witness firsthand how our intelligent, AI-driven nonconformance management system automates tasks, identifies patterns, and streamlines processes—making your quality management faster and more efficient.

  • Discover What Your Perfect Nonconformance Tracking System Should Look Like

    Explore how Qualityze advanced nonconformance tracking system provides real-time visibility, intuitive dashboards, and comprehensive reporting tools, giving you complete control over nonconformance events.

  • Is It Worth the Hype? Find Out for Yourself!

    Don’t just take our word for it. Use the demo to see if Qualityze lives up to its reputation as a leader in the world of Quality. Experience how easy it is to ensure compliance, streamline workflows, and drive continuous improvement.

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Frequently asked questions

Answers to commonly asked questions

If you have more questions feel free to reachout to us.

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General

What is Nonconformance Management Software, and how does it help?

Nonconformance Management Software is a system that helps businesses detect, document, and resolve nonconformance events that deviate from quality standards. It automates workflows, tracks issues, and ensures compliance with regulatory standards, helping organizations resolve quality problems efficiently and prevent them from recurring.

How does Qualityze Nonconformance Management System work?

Qualityze offers a comprehensive nonconformance management system that automates the entire process, from detection and categorization to root cause analysis and corrective actions. It provides real-time tracking, automated workflows, and AI-driven insights to streamline nonconformance management and ensure regulatory compliance.

What is the difference between Corrective and Preventive Actions (CAPA) and Nonconformance Management?

While nonconformance management focuses on identifying and resolving quality issues that have already occurred, CAPA involves implementing corrective actions to fix the root cause of the issue and preventive actions to stop it from happening again in the future. Nonconformance management is often the starting point for initiating CAPA.

Why is defect code management important in a Non Conformance Tracking System?

Defect code management is critical in a non conformance tracking system because it standardizes how issues are categorized, making it easier to track recurring problems, analyze trends, and implement corrective actions. By using predefined or customizable defect codes, businesses can ensure consistent categorization and faster resolution of nonconformance events.

What industries benefit most from Nonconformance Management Software?

Nonconformance management software is widely used in industries with stringent quality and regulatory requirements, such as manufacturing, healthcare, pharmaceuticals, medical devices, automotive, and aerospace. These industries rely on nonconformance management to ensure product quality, safety, and compliance with standards like ISO and FDA regulations.

How does AI improve Nonconformance Management?

AI enhances nonconformance management by automating manual tasks, detecting patterns in nonconformance events, and predicting future quality risks. AI-powered insights help organizations resolve issues faster and prevent similar nonconformances from recurring. Qualityze AI-powered recommendations make it easier to identify root causes, implement corrective actions, and continuously improve quality management processes.

How can I ensure my Nonconformance Tracking System is compliant with regulatory standards?

A compliant nonconformance tracking system must align with industry regulations such as FDA, ISO, and GxP. It should provide features like audit-ready documentation, traceability, automated workflows, and reporting capabilities. Qualityze ensures compliance with built-in regulatory checks, documentation features, and audit trails.

What is the role of Root Cause Analysis in Nonconformance Management?

Root Cause Analysis is a crucial part of nonconformance management, helping to identify the underlying reasons for a nonconformance event. Tools like 5 Whys or Fishbone Diagrams are commonly used to determine why the issue occurred, ensuring that corrective actions target the real problem and preventing its recurrence.

How does Qualityze ensure real-time tracking in Nonconformance Management?

Qualityze provides a robust, cloud-based nonconformance tracking system that offers real-time visibility into nonconformance events. With customizable dashboards, automated notifications, and integrated reporting tools, Qualityze ensures that teams can track, manage, and resolve nonconformances in real-time, minimizing downtime and enhancing overall quality management.

Compliance

How Qualityze EQMS ensures compliance?

Qualityze EQMS ensures compliance by providing features that comply with industry-specific standards, such as ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR Part 820, AS9100, and IATF 16949. The solution is built on the Salesforce platform, which provides a secure and compliant cloud infrastructure. Qualityze EQMS allows businesses to maintain a complete audit trail of all quality data, ensuring regulatory compliance and reducing the risk of non-compliance.

The software also provides configurable workflows that allow businesses to enforce compliance with their own internal policies and procedures. The workflows can be customized to fit specific requirements and ensure that all processes are standardized and consistent across the organization. The solution provides real-time visibility and reporting, allowing businesses to quickly identify areas of non-compliance and take corrective action. Qualityze EQMS also provides automatic version control and document management features, ensuring that all documents are up-to-date and comply with relevant regulations.

How Qualityze can provide free life time updates? What does “free lifetime update" include?

As a cloud-based solution, Qualityze EQMS is continually updated with the latest features and functionalities to ensure compliance with changing regulations and industry standards. Qualityze provides free lifetime updates to its customers to keep them up-to-date with the latest technology advancements and features. These updates are automatically applied to the system without any additional cost or disruption to the user. Qualityze’s software as a service (SaaS) model allows for seamless integration of new features and bug fixes, which means that customers always have access to the latest version of the software. Qualityze’s dedicated team of developers and quality experts continuously work on enhancing the product to ensure that it meets the evolving needs of the customers and helps them stay ahead of the competition.

What does Qualityze's free lifetime update include?

Qualityze's free lifetime updates include bug fixes, security updates, feature enhancements, and new functionalities. These updates ensure that the Qualityze EQMS solution stays up-to-date and continues to meet the evolving needs of the industry and regulatory standards. The updates are provided without any additional cost to the customers and are automatically deployed to their systems. The Qualityze team ensures that the updates are thoroughly tested before being released to the customers to ensure their smooth integration and minimal disruption to their business operations. The free lifetime updates help customers to leverage the latest technological advancements and ensure that their quality management processes remain compliant and effective.

Security

How secured is Qualityze EQMS?

Qualityze EQMS provides a highly secure environment for managing quality data. It is built on the world’s leading cloud-based platform, Salesforce.com, which has a robust security framework with multiple layers of security features, including:

  • Data Encryption: Qualityze uses AES-256 encryption to secure data in transit and at rest, providing a high level of data security.
  • Role-Based Access Control: Qualityze provides access controls based on user roles, ensuring that users only have access to the data they need to do their job.
  • Two-Factor Authentication: Qualityze uses two-factor authentication to provide an additional layer of security when logging in to the system.
  • Regular Security Audits: Qualityze conducts regular security audits to identify and address any vulnerabilities in the system.
  • Compliance with Industry Standards: Qualityze complies with industry-specific standards such as ISO 9001, ISO 13485, 21 CFR Part 11, 21 CFR Part 820, AS9100, and IATF 16949, ensuring that the system meets the highest security standards.

Overall, Qualityze EQMS provides a secure environment for managing quality data, giving organizations peace of mind that their sensitive data is protected.

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Client Testimonials

Qualityze Drives Innovation and Continuous Improvement with Strategic Partnership

Qualityze Drives Innovation and Continuous Improvement with Strategic Partnership

We have a Strategic Partnership with Qualityze. They have been an incredible partner in the configuration and
implementation of the eQMS software. I have participated in several system implementations across multiple platforms and Qualityze is ...

Corporate Quality Assurance Manager, Kenco Group

Excellent support shifting audits to Salesforce

I-CAR is a training organization with hundreds of instructors around the country. We regularly evaluate our instructors to provide quality and relevant education to our students. Due to rapid growth over a few years, our home-built system became i...

Manager, Quality Engineering
Excellent Quality Management Solution

Excellent Quality Management Solution

I manage training and document control. An effective document control system is among the most critical tools for
compliance in highly regulated industries like ours. Document control is essential in QA/RA environments because it
touches all...

Omron Healthcare, Inc
Qualityze For Our eQMS

Qualityze For Our eQMS

With every new product comes the anxiety of, “Will this work? Is it complicated? Will I have support, etc.?” but with
Qualityze and their team, they not only met our needs, but they also surpassed our expectations. Qualityze has pro...

Ortho8
Qualityze: A powerful product to manage all your quality needs

Qualityze: A powerful product to manage all your quality needs

Rinchem is focused on third party warehouse and transportation logistics. The growth in our company has lead to a need for a robust system that can manage multiple pillars of quality, from start to finish within the same system. We have implemente...

Application Analyst, Rinchem
The right fit and great support

The right fit and great support

For years we had managed all our documents, training, and changes manually using numerous spreadsheets and multiple applications. As our business grew, continuing with those methods was not feasible. We spent many months reviewing many different o...

Sr. Manager, Quality Systems, Cell Signaling Technology

Qualityze Organized Our Quality Processes

Our business was growing rapidly, and we needed help to get us organized, that’s when brought in the Qualityze Team. The Qualityze Team helped us execute our vision for the company and organized our processes to industry best in class standa...

Administrator, Blue Rabbit
Qualityze Our EQMS Solution

Qualityze Our EQMS Solution

As our company’s complaint volume increased, we decided that a new system would be needed to accurately track and report on our consumer complaints. After researching, we landed with Qualityze as our best EQMS vendor of choice. The Qualityze...

Sr. Compliance Analyst, AmeriSave Mortgage Corporation

We chose Qualityze for its simplicity!

Qualityze is an out-of-the-box, ready-to-use, Quality Management System. Since it runs as an independent, Cloud-based application, which is much nicer than trying to expand an expensive ERP system, muddied with a bunch of unwanted ERP features; th...

Quality Coordinator Master Tag Montague, MI
Qualityze EQMS implementation experience and features!!!

Qualityze EQMS implementation experience and features!!!

Our experience working with the Qualityze implementation and support team was extremely positive. They made sure we understood their base product and the best ways to fit the product to our business processes through configurations to enable ...

Global Quality Assurance Manager
Qualityze eQMS with Incredible Customer Service!

Qualityze eQMS with Incredible Customer Service!

Our business was faced with tight timelines to go live in a new electronic Quality Management System, and the Qualityze team made it happen! Our business has numerous complexities related to different sites operating under d...

Associate Supplier Quality Manager at ZimVie Spine

Our experience with Qualityze EQMS

From the moment we partnered with Qualityze Inc. for our Quality Management System needs, we knew we made the right choice. The system itself has transformed our quality management practices, providing us with the tools and insights we need to mai...

Daniel Boo
Qualityze our EQMS System

Qualityze our EQMS System

My team and I worked with Qualityze to implement a Complaint management solution which provided dashboards, reporting, response templates and the Documents module for policies and procedures. We completed much of the work at a very busy time. The ...

AVP of Compliance, AmeriSave Mortgage Corporation
A great choice for an eQMS!

A great choice for an eQMS!

After months of reviewing potential Electronic QMS software packages for our company we concluded that Qualityze was the clear choice for us. The task of implementing this type of system seemed quite daunting but working with the team at Qualityze...

QA Consultant, Sparrow Pharmaceuticals
Qualityze has been instrumental Partner for our QMS system

Qualityze has been instrumental Partner for our QMS system

Qualityze has been instrumental in our companies transition from ISO 9001 to IATF 16949. Auditor from our registrar and customers have been impressed by the use of the Qualityze modules. The Qualityze team is easy to work with, and helpful in find...

Vacuum Engineering and Materials
Our Experience with Qualityze Implementation.

Our Experience with Qualityze Implementation.

HBNO CO. is a relativity new company, started 7 years ago, and growing bigger year after year. In 2021, our management thought of introducing an EQMS system which could automate our existing process and move us away from a paper-based process to a...

Industrial Engineer IL, Health & Beauty Natural Oils Co., Inc
Qualityze Implementation For Fast-Paced Manufacturing

Qualityze Implementation For Fast-Paced Manufacturing

We are a rapidly growing manufacturing organization that seeks to integrate our quality system software with various other programs, including our MRP system. After months of searching the right solution and fit, we determined that the Qualityze Q...

Director of Quality Operations, Monarch Industries Limited
Qualityze has met all of our requirements.

Qualityze has met all of our requirements.

Infinity Molding and Assembly is a small custom injection molder that was using a highly paper based QMS. The search began for a new QMS software and after months of searching and previewing a few other systems we chose to more forward with Qualit...

Quality Systems Manager, Infinity Molding & Assembly
Our experience with Qualityze eQMS

Our experience with Qualityze eQMS

Over the past year Medimaps has implemented six of the Qualityze QMS modules to migrate the most relevant parts of the company’s Quality Management System to an electronic tool. The Qualityze team has been remarkable in competence and effici...

Director of Regulatory and Quality, Medimaps Group SA
Methodical and collaborative experience!

Methodical and collaborative experience!

With a small Quality Team, the implementation of Qualityze allowed us to notice drastic improvements in our workflows. Working with Qualityze has been great, and that has clearly been demonstrated with the easy transition and ease of product usage...

Quality Specialist, Cell Signaling Technology
Best Business Partner for QMS

Best Business Partner for QMS

Over the past year Rinchem has implemented several the Qualityze QMS modules to enhance our Quality department. Our Qualityze team has been excellent partners in development and customizations to meet our specific requirements. They have provided ...

QMS Document Control Coordinator, Rinchem Co. Inc.
Highly Recommend

Highly Recommend

Our company has been growing rapidly & we absolutely needed an eQMS solution immediately. Qualityze’s capabilities surpassed our wish list & the modules met our requirements. Implementation has been an ideal transition with guided as...

Chief Regulatory Office, Ortho8
Excellent Quality Management System

Excellent Quality Management System

Qualityze has made our processes much more organized. Everything is in one place, and it is easy to search and run
reports. The Qualityze team has also been extremely helpful as we implement new modules and help find ways to improve processes t...

QA Analyst, Omron Healthcare, Inc
Excellent software for document management and QA tasks

Excellent software for document management and QA tasks

In the past, our medical device company struggled to efficiently manage Quality processes such as document management, non-conformances, audits, employee trainings, customer complaints and CAPAs. After a systematic search and assessing multiple QM...

Quality Director, Garreco Dental
Incredible Value, Incredible Partner

Incredible Value, Incredible Partner

Qualityze drives value through innovation and they are quite dedicated to this. The differentiator for Qualityze is
their outstanding commitment to customer service and innovation. We could not ask for a better partner and it doesn’t hurt...

Director, Quality Assurance & Regulatory Affairs, Kenco Group
 Amazing Cloud EQMS Software!!!!

Amazing Cloud EQMS Software!!!!

After looking, viewing demos from several Quality Management Solutions, Qualityze checked off all the boxes of being cloud-based, user-friendly, and totally customizable. The Qualityze team has been very supportive and helped us every step of the ...

Sr. Manager Quality, Care/Of
Exceeded Our Strategic Goals in an Exceptionally Efficient Manner. All QMS processes in one system!!

Exceeded Our Strategic Goals in an Exceptionally Efficient Manner. All QMS processes in one system!!

We currently have multiple solutions that resulted in us having disparate quality systems to manage with multiple operational challenges. We were looking for a solution that could consolidate all our quality systems into one centralize repository....

Quality Assurance Coordinator, Scholls Wellness
Qualityze - Enterprise Quality Management Solution (EQMS)

Qualityze - Enterprise Quality Management Solution (EQMS)

Our organization selected Qualityze as our new eQMS system as our previous eQMS process includes the use of multiple systems across the business and associated costs for each. Qualityze provided us with a solution as a system that is highly c...

ZimVie Quality Director
Qualityze EQMS Implementation Experience

Qualityze EQMS Implementation Experience

My team and I were looking for an audit management system to accommodate a unique audit workflow. Working very closely with the Qualityze technical team, I can honestly say that they were always patient and provided me with clear guidance on how t...

SVP, Advisory Consulting COMPLY
Thank you Qualityze!

Thank you Qualityze!

Qualityze has tremendously helped our business fit its complicated model into an electronic quality management system. It has wonderful reporting and dashboard capabilities, as well as being totally customizable to fit our business’s needs. ...

Quality Control Associate, Care/Of
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