Risk Management in a Modern Enterprise Quality Management System
Minimize risk. Improve operations. Create business opportunities.
Risk Management Software
Utilizing the right technology and practices for risk management enables consistent, risk-based decisions that extend across the product lifecycle. AssurX Risk Management Software facilitates the continuing process of risk scoring, identification, assessment, mitigation, and prevention.
Integrated quality risk management allows you to take proactive steps to prevent problems, or have processes in place to resolve them when they do. AssurX provides maximum visibility into your enterprise-wide state of risk, including quality system processes, procedures and products.
Using quality risk management is a continuous process that minimizes risks to product quality throughout the life-cycle in order to balance benefit and risk.
Quality Risk Management Aligned with Industry Standards
The core methodology of AssurX Risk Management is consistent across industries and can be used by Life Sciences (Medical Device, Diagnostics, Pharmaceutical, Biotech), Food & Beverage, and any other manufacturing enterprise (High-Tech, Consumer, Industrial).
AssurX allows you to effectively manage:
- Risks associated with failure or breakdown of a QMS process
- Risk of product failures and/or product quality
The AssurX Risk Management Solution supports compliance objectives aligned with the following standards and guidance:
Benefits of Integrating Risk Management into the EQMS
AssurX Risk Management software is highly configurable, enabling you to create workflows with decision paths that satisfy the needs of your organization. Risks initiated from any source are automatically associated with related product records across the system, forming an enterprise level approach for rapid mitigation. AssurX’s flexibility and intuitive approach to managing risk results in significant benefits including:
AssurX facilitates risk-based thinking into the deployment and management of an enterprise quality management system (EQMS). Risk Management is incorporated into the following AssurX solutions:
AssurX: Connected Quality and Validated Compliance
AssurX provides expert technical and program management oversight for customer deployments around the globe. We employ a structured implementation process, providing a consistent method for architecture design.
AssurX: Quality & Compliance Systems for Every Enterprise
When you choose AssurX, you’re choosing decades of expertise in regulated environments and continuous innovation in quality management. Our unwavering focus on quality management means you’re getting a best-of-class solution, not a scaled down or inflexible software solution.
One Platform. Every Solution.
Seamlessly integrate all quality and compliance management processes with one software system. Start by using just the solutions you need now, then easily add more as you are ready. No other system is easier to deploy, configure, and modify.