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CAPA Management Solution

Proactive CAPA Management to Resolve Quality Issues at the Root

Regulated industries requires a consistent CAPA (Corrective and Preventive Actions) framework to eliminate systemic quality issues, from defects to nonconformances. Our AI-powered CAPA management system empowers businesses to align their workflows with proven best-practices and regulatory standards to minimize CAPAs and related risks.

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Proactive Quality Assurance with AI – Your Intelligent QAI Assistant

Accelerate CAPA investigations, automate workflows, and get recommendations for corrective actions with our QAI assistant. Our solution provides real-time insights into potential risks, ensuring faster resolutions, while helping you maintain regulatory compliance, and drive continuous improvement.

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Ensure Consistency Right from the Beginning

Save time and ensure data integrity with ready-to-use, pre-built CAPA workflows. You can capture all CAPA-related information in a centralized database. CAPA fields typically include the Title, Description, Problem Statement, CAPA Source, an Auto-generated Number, Reported Date, Reported By, Criticality, and CAPA Owner. You can easily add or remove fields to tailor the workflow to your specific requirements. Using standardized CAPA forms helps maintain consistency and accuracy in reporting, analysis, and root cause investigation.

Detailed Reporting to Address Systemic Issues Faster

Our system captures every detail needed to resolve issues quickly and effectively. You can track root causes, assign responsibilities, and keep everyone in the loop with just a few clicks—ensuring accountability and transparency. With built-in reporting features, you can generate detailed reports on the status of corrective actions, driving accountability and ensuring timely execution of corrective actions. This clarity drives faster, more informed decision making.

Prioritize the Right Issues with Risk Assessment Tools

Some problems require immediate attention! Our built-in Risk Matrix helps you to identify those problems by assessing each issue's potential impact. The system helps evaluate risk of the CAPAs reported so your team can prioritize their tasks accordingly. This strategic prioritization helps minimize downtime and prevent the risk of recurring quality issues.

Get to the Root Cause with Structured Investigations

Uncover the root cause. Our CAPA solution comes with tools like 5 Whys, 5 How's, fishbone and more to help you uncover the real cause of problems, so you can resolve them effectively. Our in-built investigation tools help your team take a thorough and systematic approach to mitigate underlying issues. It further helps you to develop and implement effective action plans to prevent their recurrence, ensuring proactive risk management.

Automate Workflows to Keep Things Moving

Set up automated reminders, email alerts, and schedule tasks in advance to make sure nothing slips through the cracks. With clear deadlines and smooth handoffs, your team will stay focused and productive. Automation also reduces manual tasks, allowing your team to focus on more strategic activities. This reduces the risk of delays and achieves faster resolution of CAPAs.

Check Effectiveness to Ensure Long-Term Success

It’s not enough to fix the problem—you need to know whether the implemented action plans are effective, reducing the likelihood of recurring issues. Our solution makes it easy to measure the desired result of the corrective actions and, make adjustments as needed. By validating the success of corrective actions, you can maintain compliance and boost confidence in your quality management processes.

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COQ

We help you save on cost of quality!

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

Qualityze CAPA Management Software allows you to save on the Cost of Quality by:

End-to-End CAPA Management
Our solution offers an end-to-end CAPA management framework, guiding you from identifying, investigating, and resolving quality issues problem identification, investigation, verification and resolution of quality issues. Every aspect—from root cause analysis to preventive measures—is tracked, managed, and verified within one system.
Configurable to Fit Your Needs
Every business has unique processes. Our solution enables you to configure CAPA workflows, templates, and reports to fit your business-specific needs. This flexibility ensures that the CAPA system adapts and supports your evolving quality management processes and regulatory changes.
Built-In Compliance Tools
Our solution includes built-in compliance tools to keep you audit-ready, providing traceable workflows and audit-ready reports that align with standards like ISO and FDA. These advanced tools and features reduce compliance burdens and help you pass regulatory audits confidently.
Seamless Integration
Our CAPA system fits right into your existing tech stack, creating a closed-loop system with your ERP, CRM, and other business systems. No more siloed data—just smooth integration and better visibility through your operations. This further improves decision-making, ensures data consistency, and fosters better communication across teams.
User-Friendly Interface
Our CAPA management solution features an intuitive, user-friendly interface that requires minimal training. This means you can save on training costs and resources. Its straightforward design ensures quick user adoption, reduced downtime and faster resolution cycles.
Continuous Improvement Culture
Our solutions help companies establish a culture of quality and continuous improvement mindset, by ensuring that they implement and follow industry best practices to prevent quality issues. The trend analysis and actionable insights from AI assistant helps you make right decisions and gain operational excellence.
Unparalleled Support and Training
Qualityze is committed to helping you achieve your quality goals. Our dedicated team of experts offers guidance, training, ongoing support, and regular updates to keep your CAPA processes optimized. We help you configure the system to support your unique needs, stay informed with changing regulatory requirements, and ensure you maximize the value of our CAPA solution.

Client Testimonials

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

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

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

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

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

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!!!

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!

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

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!

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 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.

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

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.

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

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!

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

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

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

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

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

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!!!!

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!!

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)

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

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!

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

All Testimonials

Industry Recognitions

Qualityze Delivering Value Across Key Roles

Discover how Qualityze CAPA Management solution enables seamless collaboration between quality, regulatory, and operations teams ensuring efficient and effective CAPA resolution.

For Quality Managers

Gain full control over your CAPA processes from the initial documenting stage till resolution. With Qualityze, you can focus on identifying improvement opportunities, minimizing recurring issues, and proactively driving continuous quality enhancements. By automating routine tasks, our solution helps minimize errors and maintain compliance with industry standards like ISO and FDA—allowing you to focus on strategic quality initiatives that matter most.

For Production Managers

Ensure seamless operations without disruption by addressing production issues swiftly and effectively. Qualityze enables you to trace and resolve root causes quickly, preventing issues from escalating. Our solution minimizes downtime by integrating corrective actions into production workflows, so you can fix problems without slowing operations. Our QAI assistant shares actionable insights from historical data to fast-track decision-making processes.

For QA/QC Technicians

Streamline the way you capture, log, and manage CAPA-related issues during inspections, audits, or production runs. Qualityze provides user-friendly forms, automated workflows, and centralized data entry, ensuring every issue is documented accurately and efficiently. Our system makes reporting fast and hassle-free, giving QA/QC teams the confidence to focus on improving quality standards and staying compliant during external audits or inspections.

For Root Cause Specialists

Investigate and resolve nonconformance events with precision using Qualityze’s advanced diagnostic tools, including 5 Whys, 5 Hows and Fishbone Diagrams. Our platform empowers you to dig deep into problems to uncover the true root causes, allowing for meaningful and effective corrective actions. Implement preventive actions on time to eliminate recurring issues and ensure that your organization stays clear of potential risks and future nonconformances.

For CAPA Coordinators

Simplify CAPA management by effortlessly assigning tasks, tracking progress, and keeping all stakeholders aligned and informed with real-time notifications and automated reminders. With Qualityze, you can ensure that every corrective and preventive action is properly executed and closed on time. The platform helps you avoid bottlenecks by maintaining full transparency throughout the process—ensuring every step is monitored, documented, and completed efficiently.

For Regulatory Affairs Managers

Maintain audit readiness with Qualityze traceable workflows and comprehensive reporting tools that align with regulatory frameworks like ISO, FDA, and other global standards. Our system ensures that every event is properly documented, with evidence-backed corrective actions that meet compliance requirements. With Qualityze, you can easily generate reports for inspections, reducing the burden of audits and giving your team confidence and peace of mind throughout the process.

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

We understand that choosing the right CAPA solution 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:

Experience AI-Powered CAPA Management Like Never Before

See how our intelligent, AI-driven CAPA management system automates repetitive tasks, uncovers actionable insights, and optimizes processes—delivering faster, smarter quality management at every step.

Discover the Ideal CAPA Management System for Your Organization

Explore the Qualityze difference through our advanced CAPA solution, featuring real-time visibility, intuitive dashboards, and robust reporting tools. It helps you go reactive to proactive risk management to ensure minimum to zero chances of recurrences.

Is It Worth the Hype? Find Out for Yourself!

Don’t just take our word for it. Schedule a free 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.

The Start of Something Amazing.

Request Demo

Frequently asked questions

Answers to commonly asked questions

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

General

Why CAPA Management Is Important?

CAPA, or Corrective and Preventive Action, is a crucial process for identifying and resolving problems in quality processes, products, or workflows. It helps organizations make informed decisions about action plans. CAPA encourages:

How to Improve Quality with Qualityze CAPA Management System?

Qualityze CAPA Management System helps you identify and eliminate root causes in your quality management system. It offers a user-friendly interface for efficient handling of CAPA processes. With this feature-packed solution, you can document quality issues, assess risks, and develop effective action plans to prevent future occurrences. However, it's important to ensure that the identified issue is a valid nonconformance for risk assessment and subsequent action implementation. Streamline your nonconformance treatment and prevent recurrence by implementing Qualityze CAPA Management Software. Request a free demo or contact our technical support for more information.

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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CAPA Management Solution

Proactive CAPA Management to Resolve Quality Issues at the Root

Proactive Quality Assurance with AI – Your Intelligent QAI Assistant

Menu

Video

Ensure Consistency Right from the Beginning

Detailed Reporting to Address Systemic Issues Faster

Prioritize the Right Issues with Risk Assessment Tools

Get to the Root Cause with Structured Investigations

Automate Workflows to Keep Things Moving

Check Effectiveness to Ensure Long-Term Success

Loading random fact...

COQ

Client Testimonials

Qualityze Drives Innovation and Continuous Improvement with Strategic Partnership

Excellent support shifting audits to Salesforce

Excellent Quality Management Solution

Qualityze For Our eQMS

Qualityze: A powerful product to manage all your quality needs

The right fit and great support

Qualityze Organized Our Quality Processes

Qualityze Our EQMS Solution

We chose Qualityze for its simplicity!

Qualityze EQMS implementation experience and features!!!

Qualityze eQMS with Incredible Customer Service!

Our experience with Qualityze EQMS

Qualityze our EQMS System

A great choice for an eQMS!

Qualityze has been instrumental Partner for our QMS system

Our Experience with Qualityze Implementation.

Qualityze Implementation For Fast-Paced Manufacturing

Qualityze has met all of our requirements.

Our experience with Qualityze eQMS

Methodical and collaborative experience!

Best Business Partner for QMS

Highly Recommend

Excellent Quality Management System

Excellent software for document management and QA tasks

Incredible Value, Incredible Partner

Amazing Cloud EQMS Software!!!!

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

Qualityze - Enterprise Quality Management Solution (EQMS)

Qualityze EQMS Implementation Experience

Thank you Qualityze!

Industry Recognitions

Qualityze Delivering Value Across Key Roles

For Quality Managers

For Production Managers

For QA/QC Technicians

For Root Cause Specialists

For CAPA Coordinators

For Regulatory Affairs Managers

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

Experience AI-Powered CAPA Management Like Never Before

Discover the Ideal CAPA Management System for Your Organization

Is It Worth the Hype? Find Out for Yourself!

The Start of Something Amazing.

Request Demo

Frequently asked questions

Answers to commonly asked questions

General

Security