Quality Risk Management Software

Utilizing the right tools and practices of quality risk management enables consistent, risk-based decisions that extend across the product lifecycle. AssurX Risk Management software facilitates risk scoring, identification, assessment, remediation, and prevention.

Adding quality risk management into your processes allows you to take proactive steps to prevent problems or have processes in place to resolve them when they do. A risk-based approach in any industry prevents the loss of time, money, financial penalties, and damage to brand image due to unanticipated product failures.

Quality Risk Management for all Industries

The core methodology of AssurX Quality 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

Aligned with Industry Standards

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

• ICH Q9 Quality Risk Management Standards for Pharmaceuticals
• ISO 9001 Standards for Quality Management Systems
• ISO 14971 Standards for Application of Risk Management to Medical Device
• ISO 13485 Standards for Medical Device Quality Systems

FMEA for Risk Identification and Evaluation

AssurX facilitates the use of failure mode and effects analysis (FMEA) for identifying potential problems and their impact. FMEA is a qualitative and systematic tool to evaluate the potential failures of products or processes. In addition to identifying the potential for failure and the level of risk, AssurX can launch deviations to investigate root causes of failures.