Connected quality processes
Tie adverse events directly to the originating complaint, the investigation, the CAPA it triggers, and any change control that follows in one place.
Next-Gen Quality Management. Built for Compliance. Powered by AI.
Adverse Event Management Software
Centralize adverse event intake, investigation, reporting, and governance in a purpose-built platform for medical device companies. Qualityze Adverse Event Management Software helps teams standardize processes across teams and markets while reducing manual effort, compliance risk, and the cost of case management.
End-to-End Adverse Event Management
Adverse Event Workflows, Built Around You
Qualityze Adverse Event Management Software helps reduce the cost and complexity of medical device vigilance with one enterprise platform for adverse event intake, case processing, regulatory reporting, and oversight.
Closed Loop · AI Insights Feed the Next AE Workflow · Qualityze Intelligence
Simplify Regulatory Navigation for Adverse Events
Qualityze intuitive interface takes the guesswork out of regulatory reporting. It streamlines how the team identifies and captures adverse events across the organization. It comes with pre-defined templates to gather all necessary details, such as event type, source, and potential impact, and store them securely in a centralized database. Using the collected data, teams can make informed decisions regarding the necessity of reporting based on the specific context of each event.
Operational Benefits
One Integrated Platform for Every Role
See how Qualityze helps quality teams streamline intake, case processing, regulatory reporting, and oversight in one purpose-built platform for medical device companies. Automate manual workflows, improve data quality, and scale vigilance operations.
Quality Leaders
Close the loop on every adverse event
Consistent event handling
Intake, evaluation, escalation, and closure follow the same controlled workflow every time for every distributor.
Continuous quality improvement
When events are linked to root cause data, you stop closing the same problem twice. Patterns feed back into design, suppliers, and process controls.
Key Challenges
Where Adverse Event Management Gets Complicated for Quality Leaders
Qualityze transforms Adverse Event management process into a connected operating model that improves reporting speed, reduces administrative cost, strengthens oversight, and supports safer products.
Incomplete Adverse Event Intake
Adverse events are reported through multiple sources, creating inconsistent and incomplete records.
Qualityze: Standardizes adverse event intake and investigation workflows across reporting sources.
Slow Reportability Decisions
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.
High Cost of Manual Case Processing
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.
Limited Visibility into Case Status
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.
Disconnected Complaints and Quality Processes
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.
Difficulties in Regulatory Coordination
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
How Qualityze Adverse Event Management Helps You Optimize the Cost of Quality
Achieve efficient, compliant adverse event management with a cloud-based solution that connects intake, evaluation, reporting, monitoring, and quality processes on one platform.
Typical cost-of-quality split, Manual Adverse Event Management vs. Closed-Loop AE Management
Where the money goes
Cost of Reactive Safety— with Manual Adverse Event Management
~70% of COQ
Manual data entry, duplicate records, delayed investigation and evaluation decisions, safety risks and higher costs
Cost of Proactive Safety — with Qualityze Adverse Event Management
~30% of COQ
Standardized form for AE intake, connected quality and safety processes, faster investigations and evaluation, lower operational costs
- Manual Adverse Event Management
- Qualityze Adverse Event Management
- Up to 50%
- Lower Operational cost
- 57%+
- Faster Case review Cycle and Reporting
- 1 source
- of quality truth
Capture
AE AccuratelyStandardize AE capture forms to gather complete information.
Prevent
Reporting DelaysSchedule automated alerts for critical cases to prevent delays/
Review
Cases FasterEnable collaborative reviews and reportability evaluations.
Sustain
Regulatory ReadinessEstablish repeatable processes for continuous compliance and safety excellence.
System Capabilities
Key Features of the Qualityze Adverse Event Management Solution
Purpose-built for regulated, quality-driven organizations, Qualityze helps safety teams to process cases faster, reduce rework, and lower operational costs while maintaining regulatory control.
Configurable Adverse Event Forms
Capture complete event, device, patient, reporter, and source information through standardized, configurable forms.
Automated Reportability Assessment
Guide teams through jurisdiction-specific criteria to determine whether an adverse event requires regulatory reporting.
Risk-Based Evaluation
Assess severity, likelihood, device involvement, and potential impact using consistent, configurable evaluation frameworks.
Rules-Based Escalation
Automatically route serious or potentially reportable events to the right safety, quality, medical, and regulatory teams.
Global Regulatory Reporting
Prepare, approve, and manage adverse event reports for the FDA, EU competent authorities, TGA, Health Canada, PMDA, and other regulators.
FDA eMDR Integration
Generate HL7 ICSR-compliant XML submissions and track FDA acknowledgment status from transmission through acceptance.
Recurring Risks Monitoring
Identify patterns of recurring events, emerging safety concerns, and potential device risks through analytics and dashboards.
Connected Quality Management
Link adverse events with complaints, investigations, CAPA, and change management for closed-loop control.
- 1 platform · Salesforce-native architecture
- No-code/Low code · Configurable to applicable standards
- Closed-loop · AE Management links to Document, Supplier and Audit
Customer stories
Real Customer Results Delivered by Qualityze
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
Why Choose Qualityze Adverse Event Management?
Manage adverse events with greater speed, consistency, and control by connecting safety, quality, regulatory, and reporting workflows on one platform.
Salesforce-Native Architecture
Enterprise security, scalability, and stability with SSO, MFA, and role-based access that quality leaders and teams' trust.
Truly Closed-Loop
Adverse Events, complaints, and audit management share one centralized platform, so you can manage quality and safety events promptly.
Compliance Ready
Validated electronic records with secure signatures and full traceability for 21 CFR PART 11/EU ANNEX 11.
Configurable, No-Code
Configure workflows, forms and reports to your business and industry specific compliance needs without writing a single line of code.
Controlled Evaluation Process
Establish best practices and controls to manage and report adverse events.
One Connected Ecosystem
AE Management is one pillar of the unified Qualityze suite of enterprise solutions designed for safety excellence.
Adverse Event Management Data Sheet
Get a complete overview of capabilities, deployment, supported standards, and integrations in one downloadable reference.
Everything you need in Enterprise Adverse Event Management Solution
Configurable AE Workflows
Configure AE workflows with approvals, reviews, and eSignature validation.
Controlled Evaluation
Evaluate the criticality, impact, and reportability of adverse events.
Timely Regulatory Submissions
Generate regulatory ready reports for every adverse event in required file formats.
Standardize Industry Best Practices
Build a consistent and controlled approach to handle Adverse events.
Support Global Regulatory Frameworks
Align AE workflows with applicable regulatory frameworks.
Integrate Across the Enterprise
Connect Adverse Event Management to enterprise quality and safety management systems.
FROM THE BLOG
Insights on
Modern Quality
One configurable quality framework that adapts to the compliance demands of every sector — from life sciences to heavy manufacturing.
Frequently Asked Questions
Qualityze Adverse Event Management Software works by providing a cloud-based platform to capture, manage, and analyze adverse events efficiently. It streamlines workflows, helps lifesciences organizations comply with regulatory requirements, and ensures patient safety by reducing risks.
See Qualityze Adverse Events Management in Action
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.