Centralized safety oversight
Manage product safety events and supporting records from one connected system.
Next-Gen Quality Management. Built for Compliance. Powered by AI.
Manage post-market safety events and recalls through controlled workflows, complete documentation, and real-time oversight. Qualityze helps you respond to emerging risks, meet regulatory obligations, and maintain audit readiness.
End-to-End Recall Management
Qualityze helps teams coordinate product safety assessments, corrections, removals, and recalls through controlled, traceable workflows while supporting timely regulatory reporting, such as the FDA’s 10-working-day requirement for reportable medical device corrections and removals under 21 CFR Part 806.
Closed Loop · AI Insights Feed the Next FSA & Recall Workflow · Qualityze Intelligence
Qualityze enables teams to standardize intake forms and guided workflows to capture key details such as safety issues, action type, initiation date, affected products, reported events, distribution details, responsible teams, and supporting evidence in one place. This establishes ownership and guide teams to next step in the workflow without any confusion.
Operational Benefits
See how Qualityze helps teams monitor open actions, recall progress, response timelines, and emerging risks through configurable dashboards and reports. Give decision-makers the insight they need to act quickly.
Consistent Product Safety and Quality Control
Manage product safety events and supporting records from one connected system.
Identify risks, initiate corrective actions, and track every activity through closure.
Align safety processes to industry best practices to strengthen delivered quality.
Key Challenges
Qualityze transforms Adverse Event management process into a connected operating model that improves reporting speed, reduces administrative cost, strengthens oversight, and supports safer products.
Adverse events are reported through multiple sources, creating inconsistent and incomplete records.
Qualityze: Standardizes adverse event intake and investigation workflows across reporting sources.
Teams often rely on email, spreadsheets, and manual interpretation to determine whether an event needs to be reported to regulatory authorities
Qualityze: Structured assessments based on event outcome, device involvement, seriousness, and more.
Teams spend significant time collecting information, assigning tasks, following up with stakeholders, reviewing records, and preparing reports.
Qualityze: Automates routing, task assignment, notifications, follow-ups, approvals, and recurring activities.
Adverse event information is often distributed across quality, regulatory, complaint, service, and safety systems, making it difficult to track the status.
Qualityze: Has Intuitive dashboards for case status, ownership, deadlines, investigation progress, approvals, and regulatory submissions.
Adverse events may require complaint investigation, CAPA, supplier action, risk assessment, or product change, but these activities are often broken.
Qualityze: Connects adverse events with enterprise quality processes for closed-loop excellence.
Adverse event reporting formats, timelines, and submission processes vary across markets and product portfolios.
Qualityze: Supports compliance-specific workflows, evaluation criteria, report templates, and reporting timelines.
Cost of Quality
Move from fragmented, reactive recall processes to a connected field safety approach. Qualityze helps teams identify safety signals, evaluate health hazards, coordinate field actions, manage recalls, track effectiveness, and reduce the risk of recurring product safety issues.
Typical cost-of-quality split, before & after
Cost of Reactive Safety — with Manual Recall Management
~70% of COQ
Cost of Proactive Safety — with Qualityze Recall Management
~30% of COQ
Identify risk signals from post-market data, complaints, product data, and more.
Assess biological, chemical, and physical hazards to control recall impact.
Initiate recovery, containment, regulatory reporting, and corrective actions.
Track response effectiveness and establish repeatable processes for continuous compliance.
System Capabilities
Purpose-built for regulated, quality-driven organizations, Qualityze helps quality teams Plan, launch, monitor, and close recalls through controlled workflows.
Configure your ideal Field Safety Assessment workflow with automated alerts and reporting to meet deadlines and streamline product safety management.
Analyze FSA data, detect patterns, identify trends, and uncover hidden insights for better decision making.
Track all your FSA or recall related data such as Nature, Reason, and Scope of Recalls, Distribution Data for Different Regions, FSA Team, Communication Plan, Source, and more.
Helps identify and mitigate potential risks in consumer goods, ensuring product safety and regulatory compliance.
Track distribution data of products' lot and batch impacted to ensure precise recall targeting by pinpointing affected products throughout the supply chain.
Streamlines recall communication directly to customers via social media and other channels, building trust and ensuring compliance.
Consistently and promptly reports the data gathered from quality and post-market collection activities to regulatory bodies.
The system comes with pre-defined templates to capture distribution data of products in a consistent manner.
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
Take control of product safety issues with a connected Field Safety and Recall System built for faster response, compliant execution, and complete visibility.
Enterprise security, scalability, and stability with SSO, MFA, and role-based access that quality leaders and teams' trust.
Recall, complaints, and adverse event management share one centralized platform, so you can manage quality and safety events promptly.
Validated electronic records with secure signatures and full traceability for 21 CFR PART 11/EU ANNEX 11.
Configure workflows, forms and reports to your business and industry specific compliance needs without writing a single line of code.
Assess biological, chemical, and physical hazards to determine their potential impact on consumers and patients.
FSA and Recall Management is one pillar of the unified Qualityze suite of enterprise solutions designed for post-market surveillance.
Get a complete overview of capabilities, deployment, supported standards, and integrations in one downloadable reference.
Configure FSA workflows based on internal and regulatory requirements.
Capture and evaluate complaints, adverse events, and other post-market data in one place.
Identify risks, assess potential health hazards, and initiate field safety actions or recalls.
Build a consistent and controlled approach to manage post-market surveillance activities.
Align FSA and Recall workflows with applicable regulatory frameworks.
Connect FSA and Recall 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.
A field safety assessment workflow enables organizations to efficiently design, track, communicate, and resolve product issues, ensuring prompt action to mitigate risks and safeguard consumers. If necessary, the system facilitates seamless product recall management, including communication and tracking of potentially defective products to ensure their removal from circulation.
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.
