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Transform CMC Development with ValGenesis iRisk

iRisk is the leading digital solution for Quality by Design (QbD) application in the pharmaceutical industry.

Screenshot of the iRisk dashboard for monitoring risks in real time

The Revolution Comes to CMC Development

ValGenesis iRisk is a digital platform built to enhance CMC process development by simplifying the application of QbD frameworks. iRisk provides a systematic, science-based approach to identify, quantify, and prioritize risks, ensuring robust control strategies and the de-risking of the process lifecycle.

  • Digitized QbD Framework: Integrate your QbD processes into a single, purpose-built application.
  • Science-Based Risk Assessment: Easily identify critical quality attributes (CQAs) and critical process parameters (CPPs).
  • Seamless Workflow Customization: Customize workflows to perfectly align with your QbD framework, preserving the integrity of your process development while removing spreadsheets.
  • Compliance with Regulatory Standards: Ensure your QbD activities are aligned with FDA, EMA, and ICH guidelines for optimal compliance.

iRisk for QbD and AQbD

iRisk plays a key role in identifying, quantifying, and prioritizing risk and then ensuring control strategies flow across the product lifecycle by simplifying the application of Quality by Design frameworks.

iRisk for QbD and AQbD
iRisk for QbD and AQbD

Key Features

Seamless QbD application

  • Digitized QbD Processes: Integrate all your QbD processes into a single, streamlined application, ensuring consistency and compliance across CMC development.
  • Risk Assessments Made Easy: Conduct comprehensive risk assessments to identify and prioritize critical quality attributes (CQAs) and critical process parameters (CPPs) for robust control strategies.
  • Science-Based Justification: Utilize a science-based approach to justify control strategies, effectively mitigating risks throughout the product lifecycle.

Flexible Workflow Customization

  • Customizable Workflows: Tailor workflows to align perfectly with your specific QbD framework, enhancing the precision and efficiency of your CMC development processes.
  • Standardized Templates: Use harmonized templates for risk assessments and documentation, ensuring uniformity and reducing manual errors.
  • Automated Information Flow: Facilitate automated information flow between different risk tools, minimizing manual updates and ensuring real-time data accuracy.

Effective Knowledge Management

  • A Single Source of Truth: Use a centralized knowledge base across multiple sites and functions.
  • Control the Information Flow: Enjoy different layers of information according to user roles.
  • Re-usable Knowledge: Access and utilize previously assessed information for informed decision-making.
  • Structured Knowledge: Capture, manage, and use knowledge in alignment with the KASA initiative.

Immersive Dashboards

  • Customizable Dashboards: Tailor your dashboard to visualize risk status according to your needs.
  • Comprehensive Metrics: Track high-risk areas, control strategies, and user productivity.
  • Project Overviews: Manage workflows with risk reduction scoring and visual charts.
  • Intuitive Customization: Create site-specific, product-specific, and equipment-specific visualization charts.

We work with ValGenesis iRisk to digitalize our QbD framework within GSK for the development of new vaccines. We are confident that iRisk will be key for simplification, acceleration, and knowledge management.

Hervé Gressard

Head of Global Project Statistics CMC Technical R&D

GSK

Quantifiably Optimize Your CMC Process

Systematically meet the QTTPs
Effectively identify CQAs and CPPs
Optimize control strategy management
Abandon traditional spreadsheets and documents

The Outcomes Your Team is Looking For

Efficiency

Perform risk assessments 50% faster.

Productivity

Minimize manual input of QbD documentation.

Speed

Generate documents three times faster.

Simplification

Replace spreadsheets with a single source of truth and harmonized templates.

Collaboration

Work seamlessly across different sites and teams with integrated workflows.

Implementing ValGenesis iRisk

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Discovery

We start with an in-depth consultation to understand your organization's unique requirements and objectives through collaborative sessions.

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Configuration

Based on the identified needs, we'll develop a detailed plan to configure iRisk and, if necessary, integrate it with your existing systems for operational continuity.

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Installation

Our team will deploy and test the system to verify that requirements are met correctly and that other systems are perfectly integrated.

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Training

We will deliver a carefully planned training program to your team to ensure you get the most out of iRisk.

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Go-Live

It's Go-live time! This marks the start of the hypercare phase where we will closely support your ValGenesis iRisk system.

When we decided to go with iRisk, we wanted to have the roll-out concluded within six months. The support we received from the team, their willingness to accommodate our requests and timelines, and their expertise in resolving all the issues that came up during the project was amazing.

Dr. Iris Ziegler

Director QbD & Pharmaceutical Sciences

Corden Pharma

Ready to transform your CMC development and simplify the application of QbD frameworks?