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.
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.
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.
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.
Do you know?
Loading random fact...
saf
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.
By leveraging Qualityze Field Safety and Recall Management, you can effectively reduce the Cost of Quality while achieving higher levels of quality and customer satisfaction.
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 Ideal Field Safety Management System 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.
Ready to see Qualityze in action?
Request Demo
Frequently asked questions
Answers to commonly asked questions
If you have more questions feel free to reachout to us.
Contact UsGeneral
What is a Field Safety Assessment (FSA) Workflow, and how does it benefit product safety management?
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.
What kind of information is stored in the Centralized FSA Database?
The Centralized FSA Database keeps all the important information about Field Safety Assessments and recalls. This includes the reason and scope of recalls, distribution data for different areas, FSA team information, communication plans, and details about vendors and suppliers. The system also keeps a detailed record to make sure everything meets regulations.
What is Health Hazard Analysis (HHA), and why is it important?
Health Hazard Analysis (HHA) is a proactive process that helps identify and mitigate potential hazards associated with consumer products. By assessing risks, HHA ensures product safety, regulatory compliance, and consumer protection.
How does the system facilitate recall communication with customers?
The Field Safety and Recall Management System makes it easy to communicate recalls to customers through emails, social media and other channels. This builds trust and makes sure customers are informed quickly, helping to follow safety standards.
How does the system handle regulatory reporting during recalls?
The system makes it simpler for you to notify regulatory bodies, which ensures that all the data collected from quality checks and market activities is reported on time. This helps you stay compliant with regulatory requirements and reduces delays in recall operations.
What features are available for managing tasks and workflows in the system?
The Field Safety and Recall Management System has several features for managing tasks, like pre-defined templates for recording product distribution details, a task scheduler for planning FSA actions, automatic approvals to keep teams updated, and secure instant messaging to make collaboration easier.
How does the system ensure the security and integrity of FSA records?
The system uses different security measures to keep FSA records safe and accurate. These include access controls, electronic signatures to verify tasks, and data encryption to protect sensitive information both when stored and while being transmitted.
What integration capabilities does the Field Safety and Recall Management System offer?
The system can easily connect with other business systems like ERP, CRM, and EQMS. This helps companies manage quality issues better, improve safety, and meet compliance requirements by centralizing recall management activities.
How does Qualityze help in reducing manual efforts in recall management?
Qualityze automates repetitive tasks, such as tracking product distribution, managing recall notifications, and regulatory reporting. This significantly reduces manual efforts, minimizes human errors, and streamlines the entire recall management process.
Products
All Qualityze ProductsNonconformance ManagementCAPA ManagementDocument ManagementChange ManagementTraining ManagementAudit ManagementSupplier Quality ManagementComplaints ManagementCalibration ManagementMaintenance ManagementInspection ManagementPermit ManagementMaterial Compliance ManagementForms ManagementField Safety & Recall ManagementAdverse Events ManagementIncident ManagementRisk ManagementBatch Records Management8D Process
Industries
LifesciencesFood & BeveragesHealthcareManufacturingMedical DevicesPharmaceuticalsBiologicsBiotechnologyNutraceuticalsCannabisCompounded DrugsBlood & TissueAutomotiveAerospace & DefenseElectric VehiclePlastic and RubberElectronics and AppliancesChemical & AgrochemicalOil & GasEnergy & UtilitiesMetals & Mining
© 2025 Qualityze™ | All rights reserved. | Privacy Policy
