Risk Management Software

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. AssurX provides visibility into your enterprise-wide state of risk, including quality system processes, procedures and products.

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Using quality risk management is a continuous process that minimizes risks to product quality throughout the lifecycle 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. Therefore, it is easy to adapt based on industry needs, including Life Sciences (Medical Device, Diagnostics, Pharmaceutical, Biotech), Food & Beverage, as well as other manufacturing enterprises (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:

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

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

Risk tools embedded within the EQMS streamlines compliance with regulatory and organizational requirements because risk is incorporated into quality processes and daily 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.

Watch a 6 Minute Video of the AssurX Risk Management Solution Now

See how the AssurX Risk Management Solution facilitates risk-based thinking into the management of your enterprise quality management system.

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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

5 / 5

“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

5 / 5

“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

5 / 5

AssurX: Quality & Compliance Systems for Every Enterprise

The quality and compliance journey can be an obstacle course of changing regulations and standards in a dynamic global market. The AssurX enterprise quality management system (EQMS) and the AssurX Energy Compliance System (ECOS) help guide organizations through the complexities of any regulatory landscape.

Our dynamic, connected quality and compliance management solutions help guide your journey by automating processes to streamline event management, minimize risk, measure performance and facilitate change. The result is a proactive system that improves efficiency, compliance readiness, product quality, and customer satisfaction.

Helpful equipment tool -Training Management Software Solution Powered by AssurX QMS

Fan turning-Training Management Software Solution Powered by AssurX QMS

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One Platform. Every Solution.

Easily integrate all your quality management and regulatory compliance processes into a single quality software system with AssurX. AssurX provides all core quality and compliance processes within the software system. This removes the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one with our quality management software.

Benefit from pre-configured workflows right from the start, ensuring a smooth transition to digital quality management. AssurX is an exceptional platform that facilitates transitioning from a labor-intensive, paper-based process to a streamlined electronic system. By adopting AssurX, you can embrace the enhanced organization that comes with digitizing documents and files.

With AssurX, enjoy the convenience of easily searchable data, allowing for quick retrieval and efficient information management, and saving valuable time. AssurX stands out as a user-friendly platform that allows for easy deployment, configuration, and integration with other software solutions.

First, implement the solutions you need now, then seamlessly connect more as you are ready. No other quality management system is easier to deploy, configure, and modify. Integrations with other software solutions make AssurX invaluable. Bid farewell to data silos and welcome a unified system for maximum efficiency.