Field Safety and Recall Management Software

Ensure Product Safety and Consumer Confidence with Qualityze Field Safety and Recall Management

Our solution helps you easily manage post-market surveillance activities, keeping your products safe after they reach consumers. With Qualityze, you can streamline Field Safety Actions and recalls, react swiftly to safety issues, and keep your customers informed. Meet compliance requirements from ISO 10377:2013, FDA, and CPSC, while enhancing your brand's reputation through prompt corrective actions. Qualityze replaces inefficient paper-based systems, ensuring safety, reducing risks, and building trust.

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Enhancing Consumer Safety: Qualityze Field Safety & Recall Management

Qualityze Field Safety and Recall Management Software ensures manufacturers and importers meet the stringent timelines for reporting corrections and removals to the FDA. With automated reminders, configurable forms, and integrated workflows, the solution streamlines report generation and submission, ensuring all actions are logged and communicated within the required 10-day timeframe to avoid compliance issues.

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Capture, Manage, and Track All FSA Details in One Place for Improved Efficiency and Traceability

Qualityze makes it easy to gather all necessary information related to Field Safety Actions (FSA), such as the type of issue, FSA initiation date, and distribution data, all in one secure platform. This centralized database ensures that everything is easily accessible and traceable. It further helps in reducing administrative effort, boosting operational efficiency, and ensuring no critical detail is ever missed.

Conduct Health Hazard Analysis (HHA) to Proactively Mitigate Risks

Assessing health hazards is crucial to ensuring consumer/patient safety. With Qualityze, you can evaluate biological, chemical, and physical hazards to understand their impact. A proactive approach helps you identify and mitigate potential risks before they escalate, enhancing consumer safety and complying with regulatory standards.

Field Safety Corrective Action vs Recall

Track Distribution Data of Products' Lot and Batch Impacted for Swift Recall Actions

Qualityze provides complete traceability of the affected products so you can easily identify the batches or lots need to be recalled. By efficiently tracking distribution data across suppliers, warehouses, and customers, you can quickly respond to recalls, minimizing the risk to consumers and reducing damage to your brand reputation.

Communicate with Customers Directly from the System for Faster Issue Resolution

Effective communication is key during a recall. With Qualityze, you can develop a structured communication plan to notify customers and stakeholders quickly. The platform enables direct communication, whether through email, social media, or other preferred channels, ensuring transparency and fostering trust during critical times.

Notify Regulatory Bodies About Product Issues/Recalls Ensuring Compliance

Keeping regulatory bodies informed is a mandatory step in managing product safety. Qualityze helps automate this process so you can notify the relevant authorities on time about recalls, ensuring compliance, and significantly reducing the risk of penalties. Automated alerts for approvals and reports help ensure all regulatory requirements are met efficiently.

Efficiently Manage FSA and Recall Records for Seamless Compliance

Managing records can be cumbersome, but Qualityze makes it seamless. With pre-defined templates and centralized storage, the system ensures that all FSA and recall records are securely maintained and easily retrievable. The audit trail functionality helps maintain compliance while providing transparency throughout the recall process.

Integrate with Enterprise Quality Systems for Closed-Loop Quality Management

Qualityze seamlessly integrates with existing enterprise-level quality systems like CAPA, Nonconformance, and Complaint Management. This integration creates a closed-loop system that helps track and analyze post-market activities, leading to improved recall tracking, enhanced risk management, and reduced likelihood of future issues.

Securely Store Field Safety Data to Protect Sensitive Information

Security is paramount when dealing with sensitive product information. Qualityze provides advanced data encryption and access controls, ensuring that all FSA-related details are securely stored. This centralized, cloud-based solution ensures that only authorized personnel have access, allowing enterprises to meet compliance requirements while protecting their data.

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COQ

We help you save on cost of quality!

Qualityze Field Safety and Recall Management Software empowers you to reduce the Cost of Quality with its comprehensive features and capabilities. By streamlining processes, improving efficiency, and ensuring compliance, it helps you save both time and resources associated with quality management. It ensures;

End-to-End Field Safety and Recall Management
Qualityze enables you to manage the entire lifecycle of field safety actions and recalls—from tracking product issues to notifying customers and regulatory bodies. Our solution ensures every detail is addressed, reducing recall risks and ensuring consumer safety.
Configurable to Fit Your Needs
Qualityze Field Safety and Recall Management is fully configurable to meet your business requirements. Tailor fields, templates, and workflows to match industry standards. Qualityze adapts to your needs, making recall management processes smooth and effective.
Built-In Compliance Tools
Stay ahead of changing regulations with Qualityze real-time compliance updates. Automatically track the latest requirements and adjust your safety and recall processes accordingly. This proactive approach helps maintain compliance while reducing manual effort.
Built-In Risk Management Tools
Qualityze includes advanced risk management tools to proactively assess and manage safety risks. With built-in risk matrix, potential issues can be identified, addressed, and resolved before they escalate, supporting a culture of quality, safety, and excellence.
Seamless Integration
Qualityze integrates seamlessly with existing quality systems, such as Complaint Management, CAPA, and ERP systems. This ensures all safety and recall processes are connected, helping you manage risks efficiently without interrupting operations.
User-Friendly Interface
Qualityze Field Safety and Recall Management features an intuitive, user-friendly interface that requires minimal training. The cloud-based solution allows you to manage recalls anytime, anywhere, while advanced search capabilities help you access crucial data quickly.
Continuous Improvement Culture
Qualityze helps you create a closed-loop system to ensure ongoing quality and compliance. Our solution empowers your team to monitor, evaluate, and improve recall processes consistently, promoting long-term excellence and resilience in managing product safety.
Unparalleled Support and Training
Our team provides exceptional support with personalized training sessions, customer assistance, and regular software updates to keep your recall management efficient. Qualityze empowers your organization to continuously improve while staying compliant with evolving regulatory standards.

Industry Recognitions

Field safety and recall management benefits to various operational functions

Discover how Qualityze Field Safety and Recall Management Solution helps different roles manage safety more easily, reduce risks, and improve operations—from Quality Assurance Managers to Data Analysts. Every business function has unique expectations from a solution, find out what Qualityze can deliver from your functions perspective.

For Quality Assurance Managers

Quality Assurance Managers make sure products meet quality and safety standards. Qualityze gives them tools to find safety problems, start corrective actions, and follow regulations. By automating safety tasks and keeping all data in one place, Quality Assurance Managers can keep things consistent, prevent issues, and improve product quality.

For Regulatory Affairs Specialists

Regulatory Affairs Specialists make sure the company follows regulatory standards. Qualityze helps you to automate reporting to regulatory bodies, keeps compliance records secure, and maintains documents for audits. This helps Regulatory Affairs Specialists save time, meet deadlines, and reduce regulatory risks.

For Supply Chain Managers

Supply Chain Managers need to see where products are at all times to manage recalls and reduce disruptions. Qualityze helps track all affected products, allowing them to quickly identify and manage recalled batches. This reduces supply chain problems and ensures quick corrective actions.

For Customer Service Managers

Prompt response from Customer Service Managers is important for maintaining customer trust during recalls. Qualityze helps them communicate directly with affected customers, giving timely updates and guiding next steps. This makes your customers feel heard and assured for an effective resolution, boosting their trust in your brand.

For Operations Managers

Operations Managers use Qualityze to simplify recall tasks and coordinate activities between teams. The solution has easy-to-use interface and configurable workflows to help Operations Managers streamline investigation and CAPA processes, improving efficiency and reducing disruptions during recalls.

For Data Analysts

Data Analysts use Qualityze's analytics to get insights from safety data. They find patterns, track performance, and give useful information for strategic decisions. By analyzing data from post-market activities, Data Analysts help spot recurring issues, predict risks, and improve product safety.

Experience the Qualityze Difference in Field Safety and Recall Management with a Free Demo.

We understand that choosing the right Field Safety and Recall Management solution is a crucial 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 Next Generation Field Safety and Recall Management in Action

Discover how our innovative solution simplifies managing field safety actions and recalls. From tracking affected products and notifying regulatory bodies to ensuring timely customer communication, Qualityze provides a powerful platform that reduces manual efforts, improves recall efficiency, and offers real-time visibility into every aspect of post-market surveillance.

Discover What Your Field Safety and Recall Management Solution Should Look Like

See how Qualityze seamlessly integrates safety and recall management with other quality processes like CAPA, Complaint Management, and Supplier Quality Management. With advanced integration capabilities, Qualityze helps you achieve a unified approach to managing risks. Track product issues, notify stakeholders, and maintain updated records—all from a single, secure cloud-based platform. Our solution ensures you stay proactive in managing product safety and compliance.

Is It Worth the Hype? Find Out for Yourself!

See how Qualityze helps ensure swift and effective recall management while improving customer satisfaction and protecting your brand reputation. Our platform is designed to simplify recall processes, enhance regulatory compliance, and boost efficiency, giving you a significant return on your investment. 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

Field Safety and Recall Management Software

Ensure Product Safety and Consumer Confidence with Qualityze Field Safety and Recall Management

Enhancing Consumer Safety: Qualityze Field Safety & Recall Management

Menu

Video

Capture, Manage, and Track All FSA Details in One Place for Improved Efficiency and Traceability

Conduct Health Hazard Analysis (HHA) to Proactively Mitigate Risks

Track Distribution Data of Products' Lot and Batch Impacted for Swift Recall Actions

Communicate with Customers Directly from the System for Faster Issue Resolution

Notify Regulatory Bodies About Product Issues/Recalls Ensuring Compliance

Efficiently Manage FSA and Recall Records for Seamless Compliance

Integrate with Enterprise Quality Systems for Closed-Loop Quality Management

Securely Store Field Safety Data to Protect Sensitive Information

Loading random fact...

COQ

Industry Recognitions

Field safety and recall management benefits to various operational functions

For Quality Assurance Managers

For Regulatory Affairs Specialists

For Supply Chain Managers

For Customer Service Managers

For Operations Managers

For Data Analysts

Experience the Qualityze Difference in Field Safety and Recall Management with a Free Demo.

See Next Generation Field Safety and Recall Management in Action

Discover What Your Field Safety and Recall Management Solution 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!