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Middle Office Platform
The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
Product Lifecycle Management
Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Design Quality
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Complaints Management
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Risk Management
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Supplier Management
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Safety Management
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
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Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
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Leveraging CAPA for Continuous Improvement
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Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
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Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
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ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
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Leveraging AI to Create a Safer Workplace Environment
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Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
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About
About ComplianceQuest
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase quality, safety and efficiency as they bring their products from concept to customer success.
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Global supply chains have made processes complex and prone to several quality risks. These quality risks exist in all industries and extend across all processes and departments.
So, every organization must have formal risk management processes to manage these risks using a risk-based approach. Quality Risk Management Software can help reduce risk by enabling the review, identification, and monitoring of risks and planning responses to mitigate risks or threats. These are critical elements in implementing quality risk management, and the process should be examined regularly and after any major incident or variation.
Quality risk management is a continuous process that facilitates risk managers to analyze risks and develop strategies to control future outcomes by taking proactive measures. Effective risk management allows risk managers to reduce repetitive losses and maximize project success by analyzing risk patterns. Quality Risk Management Software is also considered an awareness and learning tool that can identify and track risk to control the negative impact and future outcomes.
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Quality Risk Management helps organizations identify, assess, and mitigate risks that could impact product quality and patient or customer safety. It is used in various industries, including pharmaceuticals, healthcare, and manufacturing. It helps evaluate potential hazards and uncertainties. When these risks are known, organizations can take proactive measures to reduce the likelihood of defects, errors, and product recalls. This approach protects consumer well-being and helps companies meet regulatory requirements and maintain a strong reputation. Quality risk management fosters continuous improvement, resource optimization, and informed decision-making, ensuring the delivery of high-quality products and services while minimizing adverse outcomes and financial losses.
ComplianceQuest’s Quality Risk Management Software has unique AI and analytical capabilities and embedded intelligence. This solution helps organizations to identify potential risks based on history and trending data. Quality and risk management leaders can use the software to support their proactive risk mitigation efforts before it becomes an unprecedented challenge. Here are some of the principles of quality risk management software:
The quality risk management process is a framework to take proper actions to protect business value, ensure product quality, and keep customers and employees safe from harm. It is a five-step process that includes identifying risks, analyzing the potential risks, prioritizing the risk based on severity, implementing a solution, and continuously monitoring the risk.
The initial step is to find the risks within the system. A Robust Quality Risk Management software can help keep all the information in a centralized location. Thus, every stakeholder can access all the details within the organization.
After identifying the risks, the severity and criticality of the risk need to be analyzed. Implementing CQ’s Quality Risk Management software can help you to map risks and inform the risk manager of their impact.
After identifying and analyzing the risk, it needs to be evaluated and prioritized. Prioritizing the risk is important as it enables the organization to gain a comprehensive view of the risk landscape of the entire organization.
After prioritizing the risks based on severity, the next step is to either contain or eliminate the risks by connecting with the experts to which the risk belongs. An integrated Risk Management Solution can send updates directly from the dashboard. A resilient quality risk management solution can send notifications to all the relevant stakeholders.
Two risks always need to be monitored and reviewed: market risks and environmental risks. An integrated quality risk management solution helps to monitor and review the complete risk framework of the organization that assures business continuity.
Here are some tools used in Quality Risk Management, such as:
Risk Matrix:
The risk matrix helps to minimize risks by visualizing the potential risks and assessing the possibility of a risk event occurring. The organization can set the priorities for an effective quality risk management strategy.
Decision Tree:
By embedding a decision tree, ComplianceQuest’s Quality Risk Management software can help to identify reportable hostile events.
Failure Mode and Effects Analysis (FMEA):
FMEA is a diagram of the operation and details of all components that encompass engineering, manufacturing, and the field, by providing a single definition of failure modes.
Best-Practice Form Design:
ComplianceQuest’s this feature helps users to collect and track relevant data for assessing risks.
Analytics and Reporting Tools:
This feature in ComplianceQuest’s quality risk management tool is designed with preconfigured or customized reports depending on users’ needs.
Collaboration:
By integrating with different processes, including CAPA, nonconformances, change management, etc., ComplianceQuest’s quality risk management software tool makes it easier for all stakeholders to participate in risk management activities. Therefore, stakeholders can collaborate and prioritize risk mitigation efforts that could impact product quality and improve operations.
Quality risk management software helps business leaders make consistent and risk-based decisions by offering the right tools and practices that can extend across the product lifecycle. Integrating ComplianceQuest’s Quality Risk Management software into your processes enables you to prevent problems, including the loss of time, financial penalties, and goodwill due to unanticipated product failures, by taking proactive steps and having processes in place to resolve them when they do.
Implementing a quality risk management strategy is a five-step process that includes:
ComplianceQuest’s Quality risk management software is an integral part of the Enterprise-wide Quality Management System with numerous advantages, including:
End-to-End Holistic View of Data
ComplianceQuest’s Quality Risk Management software integrates seamlessly with other enterprise systems such as ERP, CRM, and SCM to get an end-to-end holistic view of data. Thus, managers can determine potential risks, evaluate and reduce them effectively, and monitor to assess their effectiveness with visibility and transparency into processes.
Better Pricing
ComplianceQuest ‘s Quality Risk Management software can be implemented based on need as a modular, cloud-based solution. So you don’t require investment in additional resources.
Efficient Training
The training module of the CQ EQMS delivers training as per the requirement so that business leaders can evaluate each employee’s risk identification and management skills.
Security
The CQ EQMS integrates with security features, including authentication, authorization, and permission-based access control aligning with all regulations and standards.
Risk Intake: Risk intake can help configure different risk types and access all risk-related documentation for assessing various operational risks.
Risk Mitigation: This feature empowers employees to participate in risk mitigation activities using electronic workflows and signatures.
Risk Detection: ComplianceQuest’s Quality Risk Management Software comes with AI and analytics-based features that help to identify potential risks.
Reporting and Analytics: You can create any number of reports and dashboards using preconfigured best practices-based reports. ComplianceQuest Quality Risk Management Software helps to track progress, monitor, and measure the success of risk mitigation measures, creating a risk-aware culture that minimizes business risks for faster growth and innovation.
Risk Assessment and Analysis: This feature generally helps to determine operational risk tolerance thresholds and policies for risk analysis and evaluation.
Monitoring Risk: This feature can help you to monitor the performance of mitigated risks to ensure their effectiveness.
Risk Registry: A centralized risk registry records all identified risks at the department, project, or company levels. This can help to make strategic decisions on potential threats aligning with the latest standards to increase evaluations, detect and review risk trends, and drive risk mitigation activities.
Mobile friendly: ComplianceQuest Quality Risk Management Software is cloud-based and mobile-ready. You can even use the mobile app to do a quality risk assessment to analyze hazards associated with any process or activity.
Risk Registry: A centralized risk registry records all identified risks at the department, project, or company levels. This can help to make strategic decisions on potential threats aligning with the latest standards to increase evaluations, detect and review risk trends, and drive risk mitigation activities
We have rolled-out CQ across our company to automate various elements of QMS requirements such as Document Management, Complaints, Non-conformances, Corrective Action (8D and A3), Supplier Management and Audit Management. We have been using the software for more than 2 years. We are glad to see how well the system is being used across the company. We have several thousand users on the system currently and working to scale the usage further. CQ solution has been configured to meet our needs, works elegantly across languages, across time zones, and business verticals. With integration between CQ and SAP to exchange critical data, the process automation provides a lot of productivity.
Lia Budiman,Solution Consultant, Continental Contitech
Managing risk and providing the best quality to your customers is essential for any organization’s financial stability and durability. Organizations must uncover challenges by identifying and preventing potential harm in terms of safety, quality, and compliance to avoid severe consequences. Here are some of the challenges of quality risk management, including:
ComplianceQuest’s Quality Risk Management Solution provides a framework that gives a holistic view of the risk landscape across business processes, product lines, and business units. Integrating with Audits, CAPAs, Change, Customer Complaints, Deviations, Nonconformances, etc., It provides a comprehensive set of tools, dashboards, and reports, to identify, assess, evaluate, treat and monitor risks regularly across the organization. This solution helps in determining operational risk tolerance thresholds and policies.
Here are some key benefits of implementing quality and risk management:
Identifying and Mitigating Risks of Advanced Therapy Manufacturing (Part A)
Checklist | March 29th, 2022
Identifying and Mitigating Risks of Advanced Therapy Manufacturing (Part B)
Quality Management System for Clinical Trials: A Risk-based Approach
Checklist | October 12th, 2021
Understanding the Medical Device Risk based Approach in a QMS
Checklist | September 27th, 2021
Organizations, regardless of size, consider a top-down approach to managing risk adequately. By creating a risk assessment matrix, you can detect risks and implement risk management strategies to mitigate each risk. Quality risk management software can help businesses:
Avoid: You can avoid risk-causing factors if you have control of the activity. Eliminate the root cause or consequence of the identified risk and reconfigure the project, so the risk disappears or is minimized to an acceptable value.
Reduce: You can minimize the negative effects or likelihood of the risk occurring by establishing early warning systems through data collection. An automated quality risk management solution can help you to evaluate and mitigate various types of risk more precisely by streamlining processes.
Accept: You should accept the risk in cases where the risk mitigation strategies are more expensive than the possible problems caused by the risk occurring.
Transfer: Additionally, you can transfer risk to a third party, such as an insurance company or subcontractor.
Identifying, understanding, measuring, and proactively managing quality risk is crucial for every organization to ensure a smooth business process that can add value to your organization. Managing risks will help achieve the objectives of an efficient and effective quality function and prevent the risks of inefficiency and ineffectiveness.
Choosing ComplianceQuest’s quality risk management solution can provide a comprehensive picture of the pulse of all quality and safety-related risks associated with any process or activity. ComplianceQuest’s solution helps minimize damage and protect business assets and resources by identifying, assessing, evaluating, and monitoring risks. Quality risk assessment evaluates hazards that define operational risk tolerance thresholds and policies.
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