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Customer-centric business models are increasingly prevalent in this competitive environment. Qualityze is therefore all set to revolutionize quality, compliance, and process management in the future. With our Next-Generation Enterprise Quality Management Suite, we strive to prepare our customers for future challenges in competitive environments and to address traditional quality issues without worrying about technology. Our […]
Field Safety Action Management Solution: Enabling Enterprises to Manage, Monitor, Measure, and to Ensure End-to-End Safety of the Product
Today’s global marketplace offers consumers various goods and services, including consumer goods, medical devices, drugs, medical products, nutraceuticals, foods, drinks, and health products. Increasing consumer demand drives products across borders as suppliers seek to lower costs and expand markets. Although many products are safe and suitable for their intended purpose, statistics show millions of people are injured or sickened by unsafe products every year.
There are laws and regulations to ensure product safety, but companies still face problems related to design flaws, inadequate manufacturing, and inadequate instructions or warnings that result in unsafe products. As a result, they need to take corrective action quickly and effectively, including recalls to eliminate the threat to health and well-being of the consumer from the unsafe product. Standards such as ISO 10377:2013, FDA-Recalls, Corrections and Removals, Consumer Product Safety Commission (CPSC) can guide them on how to establish and manage field safety action and recall program. By following the established program, companies can conduct a successful field safety action and recall, which minimizes legal and reputation risks, and reduces potential health and safety risks for consumers.
Companies have an obligation to consumer safety and post-market surveillance programs must be established to fulfill the obligation. Unfortunately, the paper-based systems may make it time-consuming to manage post-market surveillance activities such as field safety action and recall management, complaint management, adverse event reporting, root cause investigation, and much more. This poses even more significant risks to brand reputation, customer loyalty, and compliance. Thus, powerful, and integrated software is needed for managing all post market activities. When a field corrective actions and recall needs to be initiated, paper-based systems can be time consuming, cumbersome, and inefficient. Finding the right post market surveillance software which includes Field Safety Management can be challenging. It is why we are here to help. You can simplify Field Safety management, documentation, gap analysis, and reporting with Qualityze Field Safety Action Management Software. Also, it ensures timely execution and documentation of all the post-market surveillance activities.
As a next-generation Enterprise Quality Management System with robust integration capability, Qualityze ensures that post market surveillance activities including Field Safety Action, Recalls, Complaints Handling and Adverse Events are managed efficiently. With our solution, you can standardize data fields to consistently capture all the required details regarding Field Safety Actions (FSA). As a result, it will improve decision-making processes. The Qualityze Field Safety Action Management solution enables enterprises to continuously analyze and improve their field safety Action management processes to keep consumers safe.
With Qualityze Field Safety Action Management, you can enforce standardized processes to:
- Capture, Manage, And Track All the FSA Details in One Place
- Conduct health hazards analysis
- Track distribution data of products’ lot and batch impacted
- Communicate with your customer directly from the system
- Notify Regulatory Bodies About the Product Issues/Recalls
- Integrate with Enterprise Quality Systems
Field Safety Action Management Overview
Qualityze Field Safety Management help enterprises to identify, investigate, and mitigate the product issues that arise during its real-time use. It enables them to manage all the post-market surveillance activities in a streamlined, timely, and compliant manner. With the advanced integration capabilities, you can use the potential of customer feedback to make continuous improvements. You can also efficiently manage regulatory reporting for the adverse events reported to avoid legal implications. Qualityze Field Safety Management is a one-stop solution to experience excellence for post-market surveillance.
With Qualityze Field Safety Management, you can effectively and efficiently:
- Manage and track all the post-surveillance activities from one place
- Identify and assess risks to determine the need for recall management
- Support single-site and multi-site field safety management activities
- Manage regulatory reporting
- Configure distribution data template for different regions
- Control access to the FSCA details and distribution data
- Analyze recall data trends for improved decision-making
Capture, Manage, and Track All the FSA Details in One Place
All the necessary information, including the type of problem, FSA initiated date, and much more, should be easily traceable when it comes to product safety. It is where Qualityze Field Safety Action Management helps achieve excellence with configurable workflows and an intuitive interface. You can configure a standardized workflow to capture all the necessary information such as FSA details, distribution data, and communication plan. It reduces administrative efforts and time on repetitive processes to maximize operational efficiency. Qualityze Field Safety Action Management simplifies the process of managing, capturing, and accessing post-market surveillance data on a centralized database, including:
- FSA Details such as Nature, Reason, and Scope of Recalls
- Distribution Data for Different Regions
- FSA Team
- Communication Plan
- Associated FSA Source
- Associated Vendors/Suppliers, and more
Enterprises can better manage their FSA and other post market surveillance activities when they have all the data in one place. In addition, the cloud-driven platform ensures improved security for all your data sources, so you will never lose any critical detail of product recalls. Moreover, you can develop and maintain a centralized system to facilitate improved product turnaround times, market share gains, and efficiency gains.
Conduct Health Hazards Analysis (HHA)
There can be numerous health hazards associated with consumer goods. They can be biological, chemical, or physical health hazards that can temporarily or permanently affect customers’ health. By understanding the hazards, we can take steps to avoid or mitigate them. Qualityze Field Safety Action Management helps enterprises evaluate health hazards of the products recalled so you can report to the regulatory bodies. This configurable solution allows you to create your own HHA that suits your business requirements.
Qualityze helps you gather and analyze information about the hazards that have already appeared or are likely to appear in a product. This allows you to identify new and recurring hazards. You can then investigate the root cause(s) to resolve the quality issues. The collected information can help identify the severity of injuries, illnesses, and hazard trends to make informed decisions and prioritize corrective actions.
Track Distribution Data of Products’ Lot and Batch Impacted
In some cases, recalls are unavoidable. The best thing you can do if you cannot avoid a recall is to take action right away. There is a lot at stake here – you need to respond almost immediately, be transparent and have an action plan to prevent an incident like that from happening again. To take immediate action, traceability of the products’ distribution data is important. You must know exactly what batch or lot is affected, where all the products are distributed, and how many products are already returned to take appropriate actions.
The unavailability of data will impact decision-making, especially for the products that may pose life-threatening risks. You may end up leaving the affected lots/batches unaccounted for. The harm, then, will no longer be limited to brand reputation or compliance; you will be putting lives at risk. This means having granular level traceability of recalled product’s lots and batches is necessary. That is what Qualityze Field Safety Action Management offers. You can efficiently capture, manage, and track recalled products at the supplier, customer, and warehouse levels. Based on the collected data, you can determine the action plan for the products that reached the market and those that are still in the supply chain. For example, if a product issue is identified once the batch is dispatched. Using Qualityze, you can quickly trace the suppliers of the same product along with the quantity each supplier has. You can contact those suppliers to hold off or return the product. Even if the product has reached the customer. You can manage the situation proactively by communicating immediate action to your customers through the desired platform.
Communicate with your Customer Directly from the System
Managing Field Safety Actions(FSAs) can be challenging if you do not have an appropriate communication plan. Your team may take longer than usual to resolve the quality issues without a plan. This will further lead to customer dissatisfaction and harm to your brand reputation. But Qualityze Field Safety Action Management can help prevent such a scenario. It helps you and your teams to develop the most effective communication plan for several types of recalls. It ensures that all the recalls are taken care of without impacting the ongoing operations or your employee productivity. Using this system, you can communicate with your team as well as customers.
The Qualityze Field Safety Action Management platform is designed with impressive in-built capabilities to keep FSA-related communication smooth. It further helps maintain a stronger brand-customer relationship while ensuring compliance. Experience the Qualityze difference today to achieve post-market excellence.
Notify Regulatory Bodies About the Product Issues/Recalls
Qualityze Field Safety Action Management ensures that the data gathered as part of quality and post-market collection activities is reported consistently and on time to regulatory bodies. You can significantly reduce the recall management cycle times with a configurable workflow design. For example, it alerts users whenever approval is due, so you do not need to follow up manually. It is also possible to maintain a summary log of events that have been reported and those not yet been reported to comply with regulatory requirements. Furthermore, it expedites the product safety management process to save time, money, and effort.
Qualityze Field Safety Action Management also enhances customer service by providing instant access to critical documents, such as complaint information and invoices. As a result, your employees make better decisions and are more productive when they access better information. As a result, you achieve operational excellence and gain market share.
Integrate with Enterprise Quality Systems
Qualityze Field Safety Action Management has advanced integration capabilities so that you can build a comprehensive and transparent recall management system. It integrates post market activities, quality data/document management, and customer feedback in a closed-loop system to help improve recall tracking, MDR reporting, trend analysis, and risk management. You can configure FSA templates, and their respective fields based on the changing quality requirements. It also improves visibility into post-market activities and their statuses with its advanced tracking capabilities. You can classify product recalls for improved response time.
By using our FSA solution, you can use one place to manage all the information related to quality events and their resolutions without worrying about security. Schedule a demo today to see the Qualityze difference.
Why Field Safety Action Management is Important?
Products are likely to pose risks for the consumer and keeping them safe is the responsibility of the manufacturer or importer. If you do not have an adequate system in place to monitor Post Market Surveillance (PMS) activities. Having a robust PMS system in place allows you to monitor and identify potential risks. The risks could be very general or severe in nature but with a must standardize the Field Safety Action management process you can take swift action to ensure minimum product recalls and zero risks to the customer. It would be best to implement a next-generation Field Safety Action Management Software. The benefits of the software are not just limited to improved brand credibility and lesser risks but will also help you unlock numerous business opportunities.
There are several reasons why field safety action management is important. Some of them are:
- It helps identify the risks arising from the products’ shortcomings
- It helps determine the probability of the incident occurrence
- It assists in assessing whether the risks outweigh the benefit that the product provides by conducting Health Hazard Assessment
- It helps to determine the action to take such as temporary/permanent withdrawal from the market, modification, exchange, retrofit, or new instruction or safety alert
- It helps ensure product safety and compliance
- It helps to improve consumer satisfaction
How does Qualityze Field Safety Action Management Help Businesses?
With Qualityze Field Safety Action management, enterprises can easily manage consumer responses, post-market activities, and related documentation. By resolving issues faster and making product enhancements, they minimize risks and optimize regulatory compliance simultaneously. In addition, you can configure the predefined data distribution templates as needed to manage distribution data and FSA details with greater efficiency and consistency.
With Qualityze Field Safety Action Management, you can:
- Proactively manage all your post-market activities on a centralized platform
- Ensure effective resolutions by integration surveillance and complaints
- Enhance product quality, safety, and effectiveness
- Provide faster response times for managing field safety action
- Manage regulatory reporting
- Securely manage FSA records
Proactively Manage All Your Post-Market Action on a Centralized Platform
One of the fundamental yet critical elements of ensuring product quality and safety after release is managing FSA. It helps ensure that your teams are proactively managing post-surveillance activities. However, using a paper-based system can consume a lot of time and lower individual productivity. That is where Qualityze Field Safety Action Management can help. It helps capture, manage, and track FSA details for different types of recalls. It comes with a centralized database where you can securely store all your FSA records and product distribution data. Also, you can configure the FSA workflows and fields for different compliance requirements, especially in global operations. This is an essential component of your quality management system as it keeps FSA-related critical information in one place.
Ensure Effective Resolutions by Integration Surveillance and Complaints
Errors are more likely to occur when disparate, siloed systems are used. Qualityze Field Safety Action Management integrates post-market surveillance activities and customer feedback in one system so you can efficiently track issues, perform gap analysis, and improve overall risk management. With the software, you can create standardized workflows to capture, manage, and track all the critical information required for FSA. Managing safety issues can also be done proactively by analyzing historical records. Qualityze is a one-stop solution for all your post-market challenges, from identifying the safety issues to tracking the product lot impacted and developing the appropriate resolution steps to mitigate them.
Enhance Product Quality, Safety, And Effectiveness
Qualityze Field Safety Action Management comes with amazing in-built capabilities so you can always proactively manage product quality and safety issues. As a result, you can avoid costly recalls and ensure improved product performance. On integration with CAPA, the software ensures the effectiveness of the resolution steps for managing product recalls and safety issues. It helps enterprises build a culture of quality and continuous improvements, so your teams are always focused on improving product quality, safety, and effectiveness. You can not only minimize product issues but can also manage design and other significant changes efficiently. As a result, your brand is trusted for its quality and safety.
Provide Faster Response Times for Managing Field Safety Action
Integrating Qualityze Field Safety Action Management with Complaints management enables enterprises to manage customer complaints more efficiently than ever. It significantly improves the response times for FSA, ensuring effective and timely resolution. You can also integrate FSA with CAPA, Audit, and Document management to create a closed-loop system for effective continuous improvements. This means you can have more control over data related to product safety. In addition, the software saves you enough time that your teams spend on tracking the complaint records and their resolution activities. Finally, providing timely resolutions ensures customer satisfaction and loyalty, which improves brand reputation.
Manage Regulatory Reporting
With the Qualityze Field Safety Action Management, you can utilize next-generation capabilities to ensure that all the data captured to manage the field safety action can be consistently reported to concerned regulatory bodies on time. You can also schedule the reporting tasks using the task scheduler. The alert and notification capability of the system keeps you informed about regulatory reporting schedule before they are due, so you do not end up facing legal action. The system enables you to maintain regulatory compliance while storing the summary logs of the types of recalls/events/incidents using the audit trail feature that you may or may not have reported yet.
Securely Store Field Safety Data
Qualityze Field Safety Action Management System automatically maintains all FSA-related details in a centralized and secure database so that you can retrieve them anywhere, anytime. As a result, the software helps organizations resolve complaints more quickly. You can also create global checklists with the software. This FSA management solution lets you capture all the details you need, so you need not worry about missing any crucial information. You can also maintain a checklist to ensure that only relevant documents are submitted to the authorities. In addition, the advanced security controls of the software make it possible to let only authorized users access captured data.
Qualityze EQMS – The Next-Generation Enterprise Quality & Compliance Management Platform to Manage Post-Market Surveillance Activities & Ensure Product Safety
With Qualityze Field Safety Action Management, enterprises can track post market action and the associated documentation to address the FSA faster and efficiently while minimizing risk and maximizing regulatory compliance. It comes with configurable templates to consistently capture distribution data, FSA details, and action plans. You can further use the data for making intelligent business decisions to ensure product safety, lesser recalls, and compliance with different business and regulatory requirements. The software has an alert and notifications feature that keeps your teams notified about pending action items such as regulatory reporting for critical issues. It also has an audit trail feature that allows you to track all the details regarding the product issues identified in the post-market surveillance. As part of its security offerings, the platform includes advanced security features. You can manage who can access FSA details and distribution data using the platform. Qualityze simplifies aspects of post-market surveillance unlike anything else you have seen before. Doesn’t it make managing product safety simpler?
Qualityze Field Safety Action Management is one of the integrated modules in the EQMS Suite that delivers industry-leading functionality and features. Powered by Salesforce.com, it provides enhanced flexibility, security, and performance. Moreover, the system provides your team with greater control and confidence in managing product safety, so it does not risk the health of your customers.
With Qualityze next-generation Field Safety Action management software, you can proactively manage post-market activities to achieve product quality, safety, and compliance excellence.