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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.
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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Contact UsA 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.
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.
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.
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.
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.
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.
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.
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.
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.
