End-to-End NC Oversight
Track every nonconformance across sites, departments, products, suppliers, and process areas from one centralized view.
Next-Gen Quality Management. Built for Compliance. Powered by AI.
Qualityze gives quality, production, and compliance teams one connected platform to capture defects, assess risk, contain impact, investigate root cause, escalate to CAPA when needed, and close every nonconformance with a complete audit trail.
Connected Nonconformance Lifecycle
Better workflows lead to faster investigations. Faster investigations lead to safer products. Qualityze helps you setup your own nonconformance reporting system for total quality control.
Qualityze Nonconformance Management software helps you capture nonconformances from the shop floor, inspection, supplier quality, customer complaints, audits, lab checks, or any process where a requirement was not met. It guides teams to record the right details from the start, including product, process, site, supplier, batch, lot, equipment, standard, specification, and affected quantity with relevant evidence.
Operational Benefits
Explore how Qualityze Nonconformance Management Software gives quality teams and leaders the visibility, flexibility, and insights they need to manage nonconformances and ensure excellence in Delivered Quality.
Product and Process Quality Oversight
Track every nonconformance across sites, departments, products, suppliers, and process areas from one centralized view.
Align every NC workflow with ISO, FDA, GMP, and internal quality requirements through configurable workflows, electronic records, and validation at every step.
Q helps analyze trends, recurring issues, risk data, and corrective action outcomes to reduce repeat nonconformances and improve quality outcomes.
Key Challenges
Discover how Qualityze Intelligent Nonconformance Management System helps teams standardize how defects, deviations, and nonconformances are reported, evaluated, and resolved.
Teams often write vague statements such as "part damaged," "batch issue," or "seal failure" to describe a defect.
With Qualityze: Configure NC capture forms or use Q to write concise problem statements with the details investigators need.
The same issue may be reported multiple times from different sources using different writing styles, making recurring patterns difficult to identify.
With Qualityze: Q helps teams identify duplicate and repeated failures before they become systemic problems.
Containment, disposition, and CAPA escalation decisions are often based on past experience, emails, or manual searches.
With Qualityze: Q helps teams identify practical next steps based on relevant historical information while keeping final decisions under quality review.
Investigators spend hours reviewing NC records to understand likely causes, and investigations often stop before reaching the underlying root cause.
With Qualityze: Q analyzes historical records and suggests likely root causes based on similar nonconformances from the past.
Not every NC requires CAPA, but recurring, high-risk, or systemic issues cannot be left as one-time corrections.
With Qualityze: Built-in risk matrices and intelligent analysis help prioritize high-risk issues and escalate systemic events to CAPA.
Defects and visible product failures captured through photos or videos still require manual interpretation, description, and classification.
With Qualityze: Q analyzes uploaded images and videos to identify visible defects and helps create an NC from visual evidence.
Cost of Quality
Poor quality is usually expensive. By the time you find out the defect and gaps, teams are left with an option to fix them with a reactive approach. Qualityze enables teams shift from reactive correction to proactive prevention.
Typical cost-of-quality split, before & after
Cost of Reactive Quality — with Manual, Reactive Programs
~70% of COQ
Cost of Proactive Quality — with Qualityze Closed-Loop Nonconformance Management
~30% of COQ
Risk-severity matrices, standardized NCRs, and AI trend analysis help manage quality events effectively.
Automated scheduling and mobile execution reduce the hours spent preparing and analyzing NCR data.
Linked CAPA accelerates NC resolution cycles, reducing rework, scrap, and repeat non-conformances.
Continuous readiness and traceability help prevent recalls, escapes, and findings that can damage customers and brand reputation.
System Capabilities
Purpose-built for regulated, quality-driven organizations, Qualityze brings best-in-class capabilities to manage defects, deviations, and quality events with intelligence.
Configure your own NC template for product, process and OOT events to capture every required detail for investigation and resolution.
Use the in-built risk severity matrix to prioritize nonconformances based on their risk severity and likelihood of the occurrence, ensuring no systemic issues sit in isolation.
Investigate the real cause of the nonconformances using in-built tools like 5Whys, 5Hows, and fishbone analysis. Document the results, evidence, and impact.
Implement the appropriate action plan – be it corrective, correction, preventive, or risk-based – to ensure effective resolution.
Evaluate the need for CAPA and escalate high risk quality events to CAPA workflow to ensure in-depth investigation and prevent recurrences of similar issues in future.
Track every nonconformance end-to-end with linked CAPA, Document, Training, Suppliers, and Inspection records on cloud.
Enable MRBs, quality teams, suppliers, and stakeholders to collaborate on important decisions like disposing of nonconforming materials or initiating CAPA.
Analyze recurring issues to understand risk patterns and trends before you act or make any important decision
Customer stories
Hear how quality and compliance leaders bring audit planning, execution, and follow-up into one connected process.
“Qualityze Calibration Management system has vastly improved and streamlined our calibration management process. Prior to Qualityze, we relied on a very manual process to track tools going in and out for calibration and maintaining what was due. Now we are able to automate this tracking and pull real-time status reports. Throughout the implementation process Qualityze has been a great partner. Qualityze helped us customize the platform to best fit our needs and they are always available for questions and readily solved any issues we encountered. They have made our transition from manual to automated tracking very seamless.”
Allison Hacker
Qualityze EQMS Implementation Experience!!!!, Allison Hacker
“When I transitioned from a large organization that had successfully utilized Qualityze for years to LifeMD Pharmacy Services, LLC, where I was tasked with building a new pharmacy from the ground up, I knew I wanted to implement Qualityze again. The platform's capabilities are robust, and the training is thorough, to make setup process easy and the results are absolutely worth it. Currently, we leverage the Document Control, Permit Management, and NC/CAPA modules, all of which have been instrumental in streamlining our operations. I highly recommend Qualityze's solutions to anyone in the pharmacy industry seeking efficiency, compliance, and reliability.”
Adam Womack
Qualityze EQMS an Awesome Experience!!!, Adam Womack
“We were tasked with moving into a new EQMS with a very short timeline for multiple modules. Then we were tasked with moving our information into a different instance of Qualityze about a year later. In both cases, the Qualityze team was fantastic at listening to our needs and developing solutions without compromising the project timelines. They were also very helpful with setting up our AS2 account for eMDR so that we were ready to submit at go-live. It has been a pleasure working with them through two set ups. As we continue to use the system and come up ways to refine our processes, the Qualityze team is always available to support us and keep us running at top speed. The software itself is very intuitive and was very easy for my team to learn. A few members of the team were apprehensive to learn a new system, but they adjusted to it quickly and were up to normal production levels within a couple of days. A life-saver has been the ability for each team member to create our own reports with data that is the most useful to us. Not only are the reports fairly easy to create, but the ability to save a favorites list and bring up reports with a single click of the button allows meetings run faster and smoother without prep time. Additionally, the reports easily keep my team members on track with their tasks throughout the day so we don’t miss any deadlines to government agencies or competent authorities. I would definitely recommend Qualityze to anyone searching for a new eQMS!”
Teresa George
Qualityze eQMS has Awesome Service and a Great End-User Experience!, Teresa George
“We have been thoroughly impressed with Qualityze’s Change Management system. Since implementing Qualityze over a year ago, our document review and approval processes have become significantly more streamlined. Qualityze ensures that all employees have access to only the most current, approved versions of documents—whether SOPs, work instructions, or forms. This has been especially beneficial during both internal and external audits, providing confidence in our document control and compliance. Additionally, the peace of mind that comes from knowing outdated documents are inaccessible for daily operations has greatly reduced the risk of errors from using incorrect information. Qualityze’s customer support is top-notch, and our project manager is always quick to provide excellent solutions to any question or issue that might arise. Utilizing Qualityze has been a game-changer for our organization.”
Heather Baughman
Quality Document Control with Qualityze, Heather Baughman
“I have been working with our Qualityze Customer Success Manager on the CAPA module implementation since early last year and highly appreciate the support and timely responses. The flexibility and configurability of the Qualityze system allowed us to configure our CAPA module quite a bit to achieve our look and feel and site-specific business workflows. The Customer Success Dept has closely worked in close liaison with the Qualityze development to ensure a smooth configuration and implementation. I 100% recommend Qualityze software and Customer Success team for your EQMS Implementation!”
Sihua (Sue) Xu
Qualityze EQMS Implementation Experience, Sihua (Sue) Xu
“We are a Biomed Mems consulting company working with customers who are developing technologies for medical implantable devices. We are a current user of Qualityze EQMS and have recommended and helped two of our customers implement their own Qualityze EQMS. With its user-friendly interface and customizable features the system has been a breeze to use. What truly impresses us is their exceptional service post implementation as they are always available to help with any issues or questions that arise. The onboarding process was very smooth and the training provided had all users functioning very quickly. Overall, Qualityze EQMS has transformed our quality processes and is an invaluable partner in our success and that of our customers.”
Del White
Qualityze EQMS - Excellent Partnership, Managing Director – Grynova Consulting Group
“Several groups within our organization needed to move out of another vendors document and training management program. Qualityze was chosen as a competitive alternative. The Qualityze team was patient with our transition delays and the timeline adjustments needed for our organization. Working closely with our internal team, the Qualityze team made the adjustments to the out of box system modules to meet our specific requirements. Implementation timelines were met with satisfied internal customers and in time for our manufacturing team’s external ISO 9001:2015 certification plans. As we continue to expand our EQMS programs with Qualityze, we look forward to the next module implementation project and rapid deployment of the production systems to improve our Quality program.”
Jake Criss
GreenLight Biosciences (GLB) - Qualityze EQMS Document and Training Management Implementation, Jake Criss
“CavinKare was in search of an EQMS company to create a centralized repository for our technical documents, allowing controlled access to our global factories. During our search, we came across the Qualityze team, who provided us with a comprehensive and satisfactory demonstration that aligned perfectly with our expectations and requirements. Our interactions with the Qualityze Professional Services team were excellent; they clearly understood our needs and configured the system to meet our expectations. Today, all our facilities utilize multiple Qualityze products, featuring a centralized data repository for Quality and Compliance. The Qualityze system is remarkably user-friendly and seamlessly accommodates users at all levels, from our Business Head to operators. We are extremely pleased to have easy access to all our controlled documents on a daily basis, and the system was quickly embraced by all our users. Qualityze EQMS has become one of our critical systems for addressing audits from external agencies and government entities, providing the necessary evidence to meet all requirements. Our entire team has been using the system for a couple of years now, and we have become reliant on it for accessing the latest technical documents available at any site. We extend our heartfelt thanks to the entire Qualityze team for their support in constructing such a unique system, serving as a single point of access to meet all our requirements”
Kalaichelvan Anbazagan
Qualityze EQMS Implementation, Kalaichelvan Anbazagan
“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 the system could be configured to meet our requirements. I was very pleased with how quickly the system was ready for testing and production. The Qualityze team was flexible and agreeable to multiple training sessions for our staff and customers who would be using the system. More importantly, they were always there when I or one of our audit customers had questions. The Qualityze team’s Product Manager’s knowledge and responsiveness was much appreciated during the entire process. Without hesitation I recommend Qualityze to other businesses looking for an audit management system.”
Marilyn Miles
Qualityze EQMS Implementation Experience, SVP, Advisory Consulting COMPLY
Fewer defects. Better quality. Take control of nonconformances, accelerate issue resolution, prevent recurring problems, and reduce the cost of poor quality with the Next-Gen Nonconformance Management System.
Enterprise security, scalability, and stability with SSO, MFA, and role-based access that quality leaders and teams trust.
NCRs, CAPA, change, and document control share one centralized platform, so every issue links to its root cause and resolution.
Validated electronic records with secure signatures and full traceability for 21 CFR PART 11/EU ANNEX 11.
Configure workflows, forms, and reports to meet your exact ISO and FDA requirements without writing a single line of code.
Q surfaces recurring issues, correlates likely root causes, and flags emerging risks before they become larger and more expensive quality events.
Nonconformance Management is a core pillar of the unified Qualityze solutions stack, designed to deliver consistent quality outcomes without compromising compliance.
Get the complete overview of capabilities, deployment, supported standards, and integrations in one downloadable reference.
Capture every nonconformance with the key details that matter.
Discover the risks that need attention based on their severity and likelihood of occurrence.
Let Qualityze AI analyze historical NCRs to suggest the next best action.
Manage every defect, deviation, and OOT effectively so delivered quality becomes the consistent outcome.
Stay aligned with ISO 9001, ISO 13485, QMSR, IATF 16949, AS9100, FDA, GxP, and other applicable regulatory requirements.
Connect Qualityze Nonconformance Management to enterprise quality and safety management systems.
One configurable quality framework that adapts to the compliance demands of every sector — from life sciences to heavy manufacturing.
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.
Discover how our next-generation quality platform can help your team reduce quality costs, resolve issues faster, standardize processes, and drive continuous improvement across your operations.
