Adverse Event Management Software

Turn Adverse Events into Drivers of Change and Quality

Navigating the complexity of adverse event management is more than complying with stringent regulations; it’s about safeguarding what matters most—patients, customers, and product integrity. By adopting a next-generation Adverse Events Management System like Qualityze, organizations can efficiently capture, report, and resolve adverse events while ensuring compliance with evolving regulatory standards. Seamlessly integrating data, insights, and workflows, this approach helps you stay a step ahead in the journey from incident to improvement.

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AI Powered Adverse Events Management for Patient Safety and Compliance Confidence

Qualityze AI Powered Adverse Event and Complaint Management Software enable organizations to systematically evaluate events based on severity and regulatory criteria for each region. With built-in guidance for every step, from evaluation to reporting, Qualityze ensures your team stays compliant, informed, and prepared, promoting a culture of transparency, accountability, and patient safety at all levels.

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Simplify Regulatory Navigation for Adverse Events

Qualityze's intuitive interface takes the guesswork out of regulatory reporting by streamlining the identification of adverse events across your organization. By capturing all necessary details, such as event type, source, and potential impact, and storing them in a centralized database, the software helps ensure a comprehensive understanding of diverse regulatory requirements across different regions or countries. This empowers your organization to make informed decisions regarding the necessity of reporting based on the specific context of each event.

Structured Evaluation for Adverse Event Reporting

With Qualityze, you can establish a systematic method to evaluate reportable events by considering key factors such as severity, likelihood, and regional obligations. This structured evaluation process ensures consistent assessment of each event and helps prioritize those that require immediate reporting. Configurable workflows enable your team to easily update evaluation criteria as new information becomes available, maintaining compliance while keeping your adverse event management agile and responsive.

Set Thresholds for Reportable Events

Defining clear evaluation criterias for adverse events helps determine which events warrant regulatory reporting. Qualityze allows you to set these criterias, flagging events that matches with these criteria for immediate action. This proactive approach ensures that critical events are addressed promptly, supporting adherence to industry regulations and demonstrating a commitment to transparency and patient safety.

Conduct Preliminary Impact Assessments for Adverse Events

Qualityze facilitates preliminary impact assessments for each identified adverse event, allowing you to compare both severity and likelihood. By categorizing events across five levels of impact—Insignificant, Minor, Moderate, Major, and Catastrophic—Qualityze ensures a structured approach that prioritizes the most critical events, enabling your organization to take timely and effective action to mitigate risks.

Serious Event Escalation and Automated Notification

For adverse events classified as serious, Qualityze provides automated flagging based on predefined criteria such as death, hospitalization, or life-threatening conditions. Immediate notifications are sent to relevant personnel, such as the safety team or medical director, ensuring prompt review and action.

Regulatory and Internal Reporting for Compliance

Qualityze streamlines regulatory reporting by generating standardized reports for submission to regulatory agencies like the FDA, EMA, TGA, Health Canada, PMDA and others within specified timelines. The system also supports internal reporting, disseminating information to internal stakeholders such as safety committees and clinical teams, enabling analysis and decision-making in a timely manner.

Signal Detection and Ongoing Monitoring

Qualityze supports signal detection through advanced data analysis, using statistical methods to identify potential safety signals and emerging patterns of adverse events. The software also facilitates ongoing monitoring, enabling periodic reviews of adverse event data to identify trends and emerging safety concerns. Product safety updates can be communicated to healthcare providers and patients as needed.

Integrate with Enterprise Quality Systems for Comprehensive Adverse Event Control

Qualityze Adverse Event Management integrates seamlessly with other quality systems such as Complaint Management, CAPA, and Change Management. This integration enables a unified approach to managing adverse events, supporting proactive mitigation, and driving continuous improvement across all quality functions. By fostering an interconnected system, Qualityze helps enhance transparency, compliance, and operational efficiency, ultimately promoting a safer environment for patients.

Integrate with FDA eMDR system

Qualityze Adverse Event Management seamlessly integrates with the FDA eMDR system, streamlining the adverse event reporting process. It automates submissions in HL7 ICSR XML format, tracks the status of reports in real-time (including Ack1, Ack2, and Ack3 acknowledgments), and ensures compliance with FDA regulations.

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

Qualityze enables you to:

End-to-End Adverse Event Lifecycle
Qualityze Adverse Event Management offers complete oversight of the entire adverse event lifecycle—from capturing initial reports to investigation, evaluation, corrective action, and ongoing monitoring. Every adverse event, regardless of its severity, is effectively managed, ensuring patient safety and regulatory compliance.
Configurable to Fit Your Needs
Qualityze is designed to adapt to your organization's needs. You can easily configure fields, workflows, and templates to match your specific adverse event reporting and management requirements, ensuring that your processes are both effective and aligned with industry standards.
Built-In Compliance Tools
Stay ahead of evolving regulatory requirements with built-in compliance tools. Qualityze streamlines adverse event reporting with real-time regulatory updates, automated severity assessments, and pre-configured workflows, ensuring your organization remains audit-ready and compliant with all relevant regulations.
Seamless Integration
Qualityze integrates seamlessly with existing quality management systems, such as CAPA, Complaint Management, and ERP systems. This interconnected ecosystem provides a unified platform for managing adverse events, eliminating silos, and promoting greater efficiency across your organization.
User-Friendly Interface
Qualityze Adverse Event Reporting features an intuitive, cloud-based interface that requires minimal training. Whether your team is in the office or working remotely, our user-friendly platform makes it easy to capture, document, and manage adverse events efficiently. Advanced search tools ensure that users can quickly access the information they need, streamlining event tracking and resolution.
Continuous Improvement Culture
Qualityze promotes a culture of continuous improvement by providing a closed-loop system for managing adverse events. It empowers your team to evaluate incident trends, implement corrective actions, and proactively enhance safety measures. By consistently monitoring and improving the adverse event reporting process, Qualityze helps ensure that your organization is resilient and prepared for future challenges.
Unparalleled Support and Training
Our dedicated support team provides personalized training, ongoing assistance, and regular updates to ensure your adverse event reporting processes remain efficient and compliant. Qualityze empowers your organization to continuously improve and adapt to evolving regulatory requirements, fostering a proactive approach to quality and safety management.

Industry Recognitions

Risk management benefits to various operational functions

Discover how Qualityze Adverse Event Management helps different roles manage adverse events more proactively and efficiently using advanced built-in capabilities—from Quality Assurance Managers to Legal Specialists.

For Quality Managers

Quality Managers play a crucial role in ensuring that adverse events are managed in alignment with quality standards. Qualityze provides tools to capture adverse events, conduct root cause analysis, and implement corrective actions promptly. This helps maintain product quality, prevent recurrence of incidents, and enhance overall safety and compliance.

For Regulatory Affairs Specialists

Regulatory Affairs Specialists are responsible for maintaining compliance with evolving regulatory requirements. Qualityze helps them stay current by providing real-time tracking of adverse events and compliance tools to streamline regulatory reporting, document submissions, and ensure alignment with FDA and global standards.

For Risk Managers

Risk Managers need to identify and mitigate risks associated with adverse events. Qualityze equips them with advanced analytics to monitor trends, assess risks, and take proactive measures to reduce liabilities and enhance patient safety. It enables a more structured approach to risk management, ensuring that all potential hazards are effectively addressed.

For Compliance Officers

Compliance Officers are responsible for regulatory adherence, and Qualityze helps them track and document all adverse event activities. With automated workflows, reporting tools, and audit-ready records, Compliance Officers can efficiently ensure compliance with FDA, ISO, and other relevant regulatory requirements.

For Pharmacovigilance Teams

Pharmacovigilance Teams are responsible for monitoring adverse drug reactions and ensuring drug safety. Qualityze helps them capture, evaluate, and report adverse events accurately, ensuring timely regulatory submissions and enhancing the overall safety profile of pharmaceutical products.

Experience the Qualityze Difference in Managing Adverse Events with a Free Demo

We understand that choosing the right Adverse Event Management solution is an important decision for your business. That's why we invite you to see Qualityze in action through a free demo. Here are three compelling reasons to take advantage of this offer:

See AI-Powered Adverse Event Management in Action

Discover how Qualityze simplifies adverse event management with AI-driven features. From capturing event details to conducting severity assessments and creating corrective actions, Qualityze reduces manual effort, minimizes compliance risks, and provides real-time insights to make adverse event management proactive and efficient.

Discover What Your Ideal Adverse Event Management System Should Look Like

Qualityze provides a comprehensive solution to adverse event management by integrating seamlessly with other quality processes, including CAPA, Complaint Management, and Change Management. With its secure cloud-based platform, Qualityze offers a unified approach to managing adverse events, helping organizations track, assess, and respond to events effectively while maintaining compliance. This holistic integration simplifies workflows and ensures all quality processes are connected for improved efficiency and transparency.

Is It Worth the Hype? Find Out for Yourself!

See how Qualityze strengthens your adverse event management processes and enhances overall business efficiency. Our platform is designed to make event assessment, response, and monitoring easier, providing you with confidence, value, and peace of mind. Experience the capabilities that set Qualityze apart as a leader in the world of quality.

The Start of Something Amazing.

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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

Adverse Event Management Software

Turn Adverse Events into Drivers of Change and Quality

AI Powered Adverse Events Management for Patient Safety and Compliance Confidence

Menu

Video

Simplify Regulatory Navigation for Adverse Events

Structured Evaluation for Adverse Event Reporting

Set Thresholds for Reportable Events

Conduct Preliminary Impact Assessments for Adverse Events

Serious Event Escalation and Automated Notification

Regulatory and Internal Reporting for Compliance

Signal Detection and Ongoing Monitoring

Integrate with Enterprise Quality Systems for Comprehensive Adverse Event Control

Integrate with FDA eMDR system

Loading random fact...

COQ

Industry Recognitions

Risk management benefits to various operational functions

For Quality Managers

For Regulatory Affairs Specialists

For Risk Managers

For Compliance Officers

For Pharmacovigilance Teams

Experience the Qualityze Difference in Managing Adverse Events with a Free Demo

See AI-Powered Adverse Event Management in Action

Discover What Your Ideal Adverse Event Management System Should Look Like

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

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!