ValGenesis iRisk

Discover the solution that unifies all risk-related activities, allowing you to identify, quantify, and prioritize risks in one powerful platform. Learn how it not only optimizes your processes and decisions but also optimizes your business.

Meet the World's Most Advanced QRM Platform

ValGenesis iRisk is a next-generation risk management platform for the life sciences, built on industry best practices and designed by SMEs with real-world expertise. Take the ultimate step toward understanding and managing risk throughout your product's lifecycle.

Designed to Optimize Your Quality Risk Management Processes



Connect and unify teams with the same workflows and templates for greater insight and increased efficiency.



Apply the most appropriate principles and tools, ensuring that your risk activities align with FDA, EU GMP Annex 15, EMA, and ICH guidelines.



Get all the benefits and none of the problems of a new tool by linking most data sources and connecting any third- party applications.



Use rich visuals to analyze and compare risks for optimal, risk-based decision-making across production lines, equipment groups, and scenarios.

Standardize Risk Management Practices Across the Organization

  • Easily map out your quality attributes, process parameters, and operations for all product lifecycle stages.
  • Evaluate, mitigate, and design robust control strategies aligned with QbD practices to promote product consistency and compliance. 
  • Perform cross-area and cross-site assessments, including cross-contamination and tech-transfer assessments, systematically. 

Assess Your Risks the Way You Need to Assess Them

  • Connect all the tools you need to identify, quantify, evaluate, and mitigate risks while generating knowledge in an integrated, holistic fashion.
  • Choose from 50+ tools to build your workflows and cover your entire risk management process.
  • Account for your production and post-production activities and maintain control of your risks. 

Never Lose Sight of What Matters

  • Keep track of risk status with user-friendly dashboards.
  • Manage projects, track risks, monitor control strategies, and ensure user productivity. 
  • Analyze auto-generated graphics and maps and create your own specific graphical queries. 

Organizations around the world are using ValGenesis iRisk

44% of top50 pharma are our clients
+130 worldwide customers

Learn More From Our Experts

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Blog Post

Product Quality Review (PQR)

Avoiding the Pitfalls of PQRs with Digital Solutions

Read the Blog Post

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Industry Insight

Risk and Data as Knowledge Enablers: A Lifecycle Approach

Read the Article

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CQV: From a Painful Manual Approach to a Smooth Digital Process


See how ValGenesis can support your digital transformation.