best risk management software

Qualityze’s Customer Success Strategy Shines in FeaturedCustomers Report

[Tampa, Florida, April 26, 2023] Qualityze, a leading provider of cloud-based quality management software, has been named a Rising Star in the 2023 Customer Success Report by FeaturedCustomers, a top reference platform for B2B software and services. The Rising Star award is given to vendors that have recently joined the FeaturedCustomers platform and have already […]

Risk Management : Minimize Operational Risks and Maximize Efficiency

Businesses must understand that an effective risk management program goes far beyond preventing compliance violations. Instead, it helps ease the significant issues and challenges associated with managing risk.

With the regulatory environment progressively shifting toward a risk-based approach to quality management, organizations are increasingly developing strategies to minimize product, process, and service risks using enterprise risk management software systems. An enterprise risk management solution may be necessary to manage and assess risk. There are several challenges to determining and mitigating risks, including identifying the most risk-prone areas, defining risk profiles, and documenting and storing risk mitigation activities. The right risk management software can simplify the entire process.

Using Qualityze risk management software, you can manage various risks impacting brand equity, product quality, and safety. This tool gives organizations a comprehensive image of their risk landscape by identifying measures, categorizing, monitoring, and managing all risk-related activities in a centralized repository. A comprehensive view of enterprise risk is vital to any organization’s success in today’s global market, as it aids in compliance, profitability, and competitiveness.

A powerful solution such as Qualityze Risk Management Solution lets regulated companies integrate risk management with other quality processes, such as complaint management, CAPA management, and audit management, which allows for better enterprise-wide control of organizational risks.

Qualityze Risk Management helps you enforce standard best practices to:

  • Create, Manage, and Track Risk Profiles
  • Define Risk Evaluation Criteria
  • Conduct Preliminary Impact Assessment of Risks Identified
  • Identify and Plan the Risk Treatment(s)
  • Perform Risk Treatment Effectiveness Review
  • Integrate with Enterprise Quality Systems

Risk Management Overview

Quality risks can slow or prevent a successful product launch, and these delays can entail additional costs. With Qualityze Risk Management, you can assess and manage risks consistently. It identifies and mitigates long-term, systemic risks by tracking and analyzing recurrences of risks. You can easily bypass the most critical risk management challenges such as disconnected systems, inconsistent risk assessments, inefficient processes by ensuring the proper risk controls and risk assessment tools in your quality ecosystem. In addition to being compliant, a proactive risk management program prepares you for competitive challenges along your journey to long-term success and business excellence. It is, therefore, imperative that you invest in an agile and powerful risk management solution such as Qualityze. With Qualityze Risk Management, you can manage:

  • Single-site and multi-site risk controls.
  • Risks, workplace incidents and adverse events.
  • Risk treatment’s effectiveness.
  • Compliance documentaton.
  • Critical training requirements.
  • Risk data reporting and analytics.
  • Process and operational efficiency.
  • Enterprise-wide decision-making.
  • CAPAs for improved risk response.
  • Compliance with applicable standards.
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risk management process

Create, Manage, and Track Risk Profiles

Having a clear understanding of risks enables an organization to make informed business decisions. This means you should collect all the relevant information to understand the risks and their impact. Qualityze Risk Management makes it simple for you. It has best-practice forms for users to gather and track relevant data for risk assessment. Plus, they are configurable too. This means you can use the forms as is or can customize them to your needs. You can also upgrade the fields with changing business and compliance requirements without any hassles. The system store all your risk-related records in a systematic order and assigns them a unique reference number for easy searchability. Using Qualityze Risk Management, you can capture all the necessary details, such as;

  • Risk Title
  • Objective
  • Risk Type
  • Product/Process/Supplier/Equipment/Department (where the risk is identified)
  • Impacted Sites
  • Risk Review Frequency
  • Last/Next Review Date
  • Evaluation Criteria/ Instruction
  • Risk Cause
  • Risk Source
  • Associated Risks, and much more.

Enterprises can make better decisions if all the critical information is stored in one repository. This enables them to analyze trends and make informed decisions based on the information. This further enhances operational efficiency and profitability. Moreover, the cloud platform improves traceability through historical risk records to develop better strategies and treatment plans. Take advantage of Qualityze risk management capabilities to achieve excellence.

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Define Risk Evaluation Criteria

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With the Qualityze Risk Management, you can define your own risk evaluation criteria for different types of risks based on their severity and probability ratio. This way, you and your teams know what all risks need more attention. You can also provide instructions for your evaluation criteria so all the team members are on the same page when it comes to risk evaluation. It saves you a lot of administrative workload to evaluate and prioritize risks. Creating your own risk matrix will help you identify acceptable and unacceptable risks and the high risks that require action to mitigate. With this risk matrix, Qualityze helps organizations save time and resources on evaluating infrequent, low-impact risks. Having a consistent evaluation criteria for risks ensures error-free, effective and faster risk review cycles.

Moreover, your risk management team gets guided through each step by the system’s intuitive interface. Training requirements are absolutely minimal.

Conduct Preliminary Impact Assessment of Risks Identified

The two main components of risk analysis are impact and probability. To categorize and prioritize risks, it is common to compare impact and likelihood since some risks can seriously impact a project’s objectives but occur only rarely. In contrast, others can have a moderate impact and happen more often. It is possible to define risk events’ qualitative and quantitative impact based on the objectives like cost, schedule, quality, scope, health, safety, and more. This is where, Qualityze Risk Management can help. The system has five levels of impacts; Insignificant, Minor, Moderate, Major, Catastrophic, that are indicative of the impacts. One risk event can impact several objectives, which is why it is important to take into account the results of all the possible objectives involved for preliminary impact assessment of risks.

With Qualityze Risk Management, you can plan and conduct preliminary impact assessment of the risks identified in hassle-free and error-free manner.

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Identify and Implement the Risk Treatment(s)

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All risk treatment options may not be cost-effective or even desirable in most cases. However, a combination of risk treatments must be selected, prioritized, and implemented. Organizations select treatment options based on their advantages, disadvantages, effectiveness, and other factors of relevance to them. Various factors, such as the law, society, politics, and economics, may also have to be considered. Different criteria may be applied when developing treatment options for safety-related risks. This is exactly what Qualityze Risk Management helps you do. You can develop and implement different treatment options to minimize the impact of highest severity. The system allows your quality managers to define mitigation strategies, preventive plans and contingency plans to treat risks proactively.

Through predefined templates, Qualityze makes it easy for companies to create and track risk treatment options. Your risk managers can discuss and record the advantages and disadvantages of each option to make a final decision.

Perform Risk Treatment Effectiveness Review

With the advanced in-built tools, Qualityze lets organizations map the success of their risk treatments. It enables your risk managers to track the inherent risk ratio and residual risk ratio to understand what’s working and what’s not. You can also leverage the configurable workflows to make effectiveness review cycles shorter yet precise. So, why waste time in evaluating the metrics that may never work. Define your own metrics to evaluate risk management initiatives using Qualityze Risk Management.

Using the advanced reporting capabilities of Qualityze Risk Management, your risk managers are also able to report gaps in risk treatments and inconsistencies to management.  This ensures you organization is continously improving the way it manages risks. Users can use the solution to select preconfigured reports or create custom reports as needed. Moreover, the solution enables regular reporting to improve enterprise oversight.

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Integrate with Enterprise Quality Systems

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Risk management workflows must integrate seamlessly with other business systems, such as ERP, CRM, EQMS, and EHS. It assists the team in building workflows incorporating risk management into quality and safety management. When an intensified risk occurs, businesses usually perform root cause analysis, CAPA, and change management procedures. Integrating the Qualityze Risk Management solution will make this seamless and connected. Moreover, it helps build a closed-loop system, which includes Complaint Management, CAPA Management, Change Management, and more. Digital management of risk-related data reduces the likelihood of errors, ill-informed decisions, and losses. Furthermore, you can scale your processes across multiple locations without worrying about data accessibility.

Being delivered on the platform, Qualityze Risk Management ensures greater flexibility, security, and reliability to connect risk management processes with other quality processes and achieve operational excellence.



Why Risk Management Is Important?

Businesses need to manage risks effectively and provide a safe working environment for employees. It minimizes the impact of potential adverse events and changes that could otherwise be disastrous to your organization by identifying and analyzing potential threats. Work Health and Safety (WHS) regulations often guide risk management. A work health and safety policy outline what is acceptable and what is not. No matter their industry, all businesses need a comprehensive risk management system. Here are four key reasons why risk management is essential for your business:

  • It reduces the risk of workplace injuries.
  • It can protect your company’s resources.
  • It significantly improves the brand image.
  • It reduces uncertainty.
  • It is crucial to successful planning and decision-making.
  • It helps reduce costs and losses.

How does Qualityze Risk Management Help Businesses?

Qualityze Risk Management helps enterprises record, manage and track batch process information. It helps them identify the production bottlenecks that can result in nonconformances, product recall compliance issues, or increased costs. By doing so, you can control the quality events and reduce the production cycle time. In addition, you can configure the RISK forms to collect validated inputs at every step. Then, you can further analyze those inputs to track trends and make intelligent decisions.

With Qualityze Risk Management, you can:

  • Gain Visibility Through Risk-Related Activities
  • Proactively Manage Risks and Minimize Their Impact on Operational Efficiency
  • Ensure Appropriate Risk Response(s) Based on the Risk Tolerance Thresholds
  • Build a Collaborative Environment to Improve Decision Making
  • Ensure Regulatory Compliance
  • Securely Maintain Risk-Related Records

Gain Visibility Through Risk-Related Activities

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Qualityze Risk Management builds a closed-loop system to keep all the risk-related activities, including documentation and evaluation, connected. It drives bigger benefits in terms of visibility. An organization can step up its resilience with end-to-end visibility, simulations and risk monitoring, enabling them to anticipate issues, mitigate risks, and take advantage of opportunities. Considering the waves of disruption ahead, organizational resilience should be a priority every day, not just during crises. This will allow us to meet changing expectations and minimize any impact.

Qualityze Risk Management also has audit trail functionality so you can quickly track all your risk-related activities, task owners, scope, review frequency, review dates, and more, in no time. The system that offers complete visibility and traceability of enterprise-wide risks is definitely a worthwhile investment for a culture of quality, excellence, and compliance.

Proactively Manage Risks and Minimize Their Impact on Operational Efficiency

Businesses can minimize risks and their impact by ensuring process continuity despite management changes. This is where Qualityze comes handy. With Qualityze Risk Management, your safety leaders can manage risks consistently across different locations and geographies by automating their risk control workflow. The system supports proactive risk management to limit the impact of risks on the operational efficiency. Plus, the task scheduler accelerates the review and approval cycle for high-severity risks.

It is possible to configure multiple risk types to assess different categories of operational risk. Qualityze allows you to initiate risk assessments at various points in a process to analyze hazards related to various activities and processes. The Qualitzye analytics report allows you to evaluate and assess risk. It also improves management awareness by enabling scheduled reporting and intelligent notification capabilities.

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Ensure Appropriate Risk Response(s) Based on the Risk Tolerance Thresholds

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By using a risk tolerance threshold, Qualityze ensures that risk-related activities are conducted and complied with according to organizational risk tolerance limits. This further helps you determine the appropriate risk response for example – if you need to initiate a CAPA or Change a process to minimize the impact of the risk. Businesses can also configure an risk evaluation matrix to separate the “Catastrophic” risks from the “minor” ones. This keeps their focus to the areas that require most attention.

Appropriate risk response not only helps keeping the risk impact to the minimum, but also drives continuous improvement. This demonstrates the business commitment to quality principles for sustainable growth.

Build a Collaborative Environment to Improve Decision Making

Through the integration of quality management processes, Qualityze provides a more effective way for different departments and geographically dispersed employees to manage risk. Collaboration between all the organization’s monitoring groups is essential for effective risk-based planning. However, the lack of collaboration and connectivity in enterprise risk management systems leaves organizations more vulnerable to risk, liability, and sanctions. That’s where Qualityze Risk Management stands out. It provides a centralized platform for your risk management team to communicate and collaborate for effective decisions.

This cloud-based Risk Management solution is all you need to build a collaborative work environment for managing risks more efficiently than ever. Would you like to experience Qualityze difference?

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Ensure Regulatory Compliance

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Qualityze Risk Management keeps all your risk-related records in a well-organized centralized database. Digital signatures enable you to validate the risk data forms at each step. By doing so, companies can avoid data gaps, scalability issues, and delays. In addition, they can support FDA Part 11 requirements for electronic records and signatures.

You can establish best practices in the organization by designing risk management and reporting workflows according to GxP, GAMP5, ISO, and a host of other regulatory standards using the configurable platform. It demonstrates your commitment to operational excellence and quality. Take advantage of our free demo offer to see how Qualityze works.

Securely Maintain Risk-Related Records

Qualityze Risk Management automatically collects all form inputs and stores them in a central repository, making the records more accessible and traceable. In audit and compliance, it can be a game changer. It takes fewer minutes to retrieve historical data or record it. You can update risk workflows using configurable forms according to changing compliance requirements, such as FDA, CGMP, GAMP5, and more. Each step of the process is validated with a digital signature.

Using the intuitive dashboards, you can quickly track the progress of treatment and effectiveness reviews of high-priority risks. You will therefore be able to minimize risk impact effectively by implementing the right controls at the right place. Additionally, the advanced security tools embedded in the system allow you to control who has access to the data related to risks. In this way, Qualityze ensures the security of your data.

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Qualityze Risk Management – Take Control of Operational Risks and Make Them Work for Your Business!

Qualityze Risk Management works for every industry, including – Medical Devices, Lifesciences, Pharmaceuticals, Cannabis/Hemp/CBD, Nutraceuticals, Biologics, Biotech, Manufacturing, Hospitality, Consumer Goods, Food and Beverages, Automotive, Aerospace, Defense, and Logistics. It helps them configure best-practices risk workflow to proactively manage enterprise risks and minimize their impact on operational efficiency. This way, you can maintain a culture of quality while driving continuous improvements and meeting compliance.

Qualityze Risk Management Solution comes with:

  • Centralized Risk Database
  • Configurable Risk Workflow
  • Predefined Reportinng Templates
  • Intuitive Dashboards
  • Automated Email Approval
  • Alerts and Notifications
  • Digital Signature
  • Seamless Integration, and more.

Qualityze Risk Management – Step Up for Effortless Risk and Compliance Management!

Managing risks and ensuring compliance are critical tasks for businesses today, particularly in regulated industries such as healthcare, pharmaceuticals, and manufacturing. Failure to comply with regulations can result in heavy penalties, loss of reputation, and even legal consequences. That’s why you need a reliable risk management system that can help you stay on top of compliance requirements and mitigate potential risks. Qualityze Risk Management is a powerful, cloud-based solution that helps you streamline your risk management and compliance processes. With Qualityze, you can easily identify, assess, and mitigate risks across your organization, and ensure compliance with all relevant regulations and standards.

Qualityze Risk Management is designed to be easy to use, with an intuitive interface that requires minimal training. It is also highly customizable, allowing you to configure it to meet your specific risk and compliance management needs.

With Qualityze, you can take control of your risk and compliance processes and ensure that your organization is always in compliance with regulations and standards. Step up for effortless risk and compliance management today and try Qualityze Risk Management!

Experience Qualityze Difference to Optimize Quality

Qualityze EQMS Suite enables you to maintain high quality standards while experiencing difference with:

Configurable Cloud-Based Platform

The Qualityze Risk Management solution is a next-generation solution that helps enterprises minimize risks and their impact on ongoing operations. This software offers a combination of a configurable and cloud-proven structure that allows organizations to streamline and automate the risk management workflow. You can quickly analyze the risk data trends for improved decision-making. Moreover, the reporting capabilities of the software can help take the risk management to the next-level.

Adherence to Compliance Standards

Qualityze Risk Management helps you align risk management workflows and reduces the complexity of risk by automating the collection of all risk-centric documentation. The software supports digital signature validation at every step of risk workflows so you can easily route a risk file for approval and authorization electronically following 21 CFR Part 11. You can create the risk data collection forms either by using the predefined templates as is or configure them to your business needs.

User-Friendly Interface

The Qualityze Risk Management Software provides organizations with an intuitive interface to simplify risk and compliance management, connecting all the risk-related processes in one system. Our cloud-based solution allows you greater flexibility to manage risk-related documentation, impact assessment, risk analysis, evaluation, resolution, and effectiveness review from anywhere. Experience the Qualityze difference to automate the risk controls and achieving operational excellence.

Intensify the Effectiveness of Risk Controls to Play the Risk Management Game at its Finest

Using Qualityze Risk Management, you can identify risk trends across an enterprise to improve process efficiency, risk management, and internal controls. The solution aligns with ISO 45001 and ISO 14001 risk principles by enabling employees to record observations in a centralized risk repository. Risk severity and probability assessment can help prioritize mitigation actions to drive better shareholder value, customer satisfaction, and employee engagement. Setting up risk controls and workflows is simple, with an intuitive and responsive interface. Digital signatures can help you further verify the data. It integrates with enterprise quality systems to assess risks, identify appropriate risk treatment, expedite approvals and reviews, achieve compliance, and track risk tolerance thresholds. By doing so, you can achieve operational excellence, improved brand reputation, and substantial growth in market share.

Through the fusion of best practices and cloud technology, Qualityze Risk Management overcomes all traditional risk mitigation challenges and fosters a culture of continuous improvement. A centralized risk repository significantly improves traceability and transparency into risk data, which allows you to make better decisions and reduces overhead expenses. Thus, you will see a rise in profits.