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.

AssurX CAPA Datasheet

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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
AssurX CAPA Management Dashboards and Analytics

The AssurX Risk Management Solution supports compliance objectives aligned with the following standards and guidance:

ISO13485

Standards for Medical Device Quality Systems

21 CFR Part 820

CGMP in Quality Systems

ISO9001

Standards for Quality Management Systems

ISO14971

Standards for Application of Risk Management to Medical Devices

ICH Q9

Quality Risk Management Guidance for drugs and biologics

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:

  • Simplified Compliance Through Quality Risk Management

    Leveraging risk tools embedded within the EQMS streamlines compliance with regulatory and organizational requirements. the spirit of the requirements by incorporating risk into processes and daily quality activities. Integrated risk tools allow you to document risk-based activities with:

    • Data analytics and reports
    • Audit-ready compliance records
    • 21 CFR Part 11 compliant electronic signatures and audit trails
    • Documentation of verification activities such as audits and FMEA reviews
    • Records of risk assessments associated with change control activities

  • Improved Operational Efficiency

    Integrating quality risk management reduces the time and costs associated with risk assessments and makes operations more efficient by prioritizing issues with the biggest impact on the company. Efficiently route tasks down the appropriate path for actions, escalations and exceptions.

    • Launch risk assessments from events such as complaints and deviations
    • Search historical records to identify similar events
    • Notify responsible parties for management review
    • Calculate risk scores based on a risk matrix
    • Determine whether risk is acceptable or unacceptable
    • Review notifications from failure mode and effects analysis (FMEA)

  • Enterprise Visibility into Quality Risk

    Quality risk management enables greater visibility into risk using predictive metrics that indicate where problems are most likely to occur and whether corrective actions were effective. Proactively identifying risk trends at the strategic level can eliminate major effects on the entire company. Configure recurring events to trigger risk assessments, and use audits to verify risk activities and conduct risk assessments on failed audit questions.

  • Informed Decision-Making

    Risk management software allows you to document and demonstrate risk-based decision-making for regulators and as well as company leadership. Gain insights into universal metrics that make decisions more objective. AssurX risk management software takes the subjectivity out of competing business decisions and turns the focus to data-driven indicators for product failure, potential consumer harm, and business losses. AssurX enables agile, risk-based decision making with top-level views of risk through reports, dashboards, notifications, and escalation activities.

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:

Audit Management

Change Management

Complaints Management

Corrective Action

Deviations

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.

DATA MIGRATION

Our integration experts are experienced with a host of different methods for performing migrations, from direct migration using AssurX data import tools.

SYSTEM INTEGRATION

AssurX delivers flexible and reliable integration with enterprise applications such as MOM, SCM, ERP, PLM, and CRM.

VALIDATION

AssurX offers CSA validation services based on the FDA’s risk-based approach, dramatically reducing validation time and cost. AssurX’s risk based validation model provides customized validation services based on a critical thinking approach that supports the GAMP 5 Model.

“Amazing system with endless configurable possibilities!”

The most helpful part of AssurX is the ability to configure it to our company needs. The biggest upside has been the ability to do away with the paper-based format we had…read the rest.

Jose C.
Quality System Software Administrator

“Very flexible and powerful”

With AssurX you can easily configure forms and workflows using the graphical tools provided. You can connect to multiple data sources quite easily. Their Professional Services team is full of…read the rest.

Sal D.
Principal Consultant

“I highly recommend AssurX as an EQMS system!”

AssurX is a Highly Configurable product and the Configuration specialist are very responsive. Using the Dev site as a template you can test out everything before migrating over...read the rest.

Natalie P.
Quality System Software Administrator

AssurX: Quality & Compliance Systems for Every Enterprise

When you choose AssurX, you’re choosing more than two 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 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.

CAPA Management

Training Management

Validation Management Solution

Document Management

Supplier Quality Management

Customer Quality Management

Complaint Management

Change Management

Risk Management

Audit Management

Quality Management Review

Deviation Management

EHS Incident Management

Calibration Management