iRISK

ValGenesis iRisk is a risk management platform designed for the life sciences industry. According to the vendor, this platform aims to unify and optimize risk-related activities, allowing users to identify, quantify, and prioritize risks in one centralized solution. ValGenesis iRisk is said to be suitable for companies of all sizes within the life sciences industry, including pharmaceutical companies, biotechnology companies, medical device manufacturers, contract research organizations (CROs), and regulatory affairs professionals.

Key Features

Consistent: According to the vendor, ValGenesis iRisk allows teams to connect and unify with the same workflows and templates, potentially providing greater insight and increased efficiency. The platform is designed to ensure consistent risk management practices across the organization and standardize risk assessment and decision-making processes.

Compliant: The vendor states that ValGenesis iRisk enables the application of appropriate principles and tools to align risk activities with FDA, EU GMP Annex 15, EMA, and ICH guidelines. The platform aims to help users stay up-to-date with regulatory requirements and industry standards, facilitating compliance with risk management regulations.

Integrable: ValGenesis iRisk is said to offer the ability to link data sources and connect with third-party applications. The vendor claims that the platform can seamlessly integrate with existing systems and workflows, consolidating risk-related information from various sources into a single platform.

Intuitive: According to the vendor, ValGenesis iRisk provides rich visuals to analyze and compare risks for risk-based decision-making. The platform offers user-friendly dashboards to track risk status and project progress. The vendor also claims that the platform generates auto-generated graphics and maps for easy risk analysis and reporting.

Standardize Risk Management Practices Across the Organization: The vendor states that ValGenesis iRisk allows users to easily map out quality attributes, process parameters, and operations for all product lifecycle stages. The platform aims to help evaluate, mitigate, and design robust control strategies aligned with Quality by Design (QbD) practices. According to the vendor, the platform also supports systematic cross-area and cross-site assessments, including cross-contamination and tech-transfer assessments.

Assess Your Risks the Way You Need to Assess Them: According to the vendor, ValGenesis iRisk provides the ability to connect all the tools needed to identify, quantify, evaluate, and mitigate risks. The platform offers a range of tools to build custom workflows and cover the entire risk management process. The vendor claims that users can account for production and post-production activities and maintain control of risks.