Digital Quality Risk Management: A ValGenesis Story

Quality risk management (QRM) within vaccine development is extremely important, as it plays a key role in ensuring the safety and effectiveness of the final product.

This blog post intends to share the narrative of a company that adopted digital transformation by integrating a quality risk management tool. It highlights the challenges encountered, the crucial steps taken to formulate a robust control strategy, and the accomplished outcomes.


Platform Implementation Journey

According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), Quality by Design (QbD) is defined in ICH Q8 as “a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.” 

The company in question encountered a challenge in managing the complexity of establishing a robust control strategy using multiple templates across diverse vaccine components. These templates, intended to support product and process understanding, as well as the analytical strategy, formed an intricate framework.

As the framework's complexity increased, the company sought a digital solution, ValGenesis iRisk, capable of seamlessly harmonizing Quality by Design (QbD) knowledge and risk management. To achieve the anticipated objectives, several phases were navigated to ensure the digital platform operated in accordance with expectations:

  • The initial phase involved conducting a workshop to clarify the use of ValGenesis iRisk and pinpoint the customer's specific needs.
  • Subsequently, the user requirements specifications were defined, and any essential system modifications were identified.
  • Finally, an iterative and incremental development process was initiated to generate the new features needed. Throughout the development of these features, the company's subject matter experts diligently monitored progress, tested novel functionalities, and consistently provided feedback. 


Digital QRM Strategy Designed

This process encompassed various phases, from identifying critical quality attributes (CQAs) to creating an analytical target profile, each contributing to the overarching goal of delivering high-quality vaccines. 

A systematic approach that unfolds separately for drug substance and drug product entities was introduced to achieve this. Within each entity (vaccine component), the workflow commenced listing quality attributes, followed by an in-depth exploration of process understanding, incorporating the usual risk assessment activities for process development. 

1. Defining Critical Quality Attributes (CQA Assessment) 

The process began by focusing on the fundamental aspect of quality — defining critical quality attributes. This step involved generating an all-encompassing list of quality attributes, each evaluated for criticality using specific criteria such as safety and efficacy. The CQA assessment, employing a scoring process that factors in impact and uncertainty, established the groundwork for subsequent phases in the strategic workflow.

2. Linking Product Development to Process Understanding

Transitioning to the subsequent stage, the strategy reveals itself by acknowledging the connection between identified quality attributes and the process parameters impacting them. Initially, a process mapping was developed, covering all process parameters. This established the foundation for a correlation matrix, assessing how each process parameter impacted a specific attribute and facilitating the determination of the parameter’s criticality. Then, there was a possibility of introducing failure modes associated with this interaction between parameters and quality attributes, along with the integration of required mitigation.

3. Consolidation of Information 

The third phase of this method involved consolidating all previously generated information associated with the different vaccine components to facilitate the definition of the analytical target profile (ATP). Utilizing the Quality by Design workflow, a complete list of attributes was compiled. This consolidated information played a vital role as a reference point in developing a robust control strategy.

4. Analytical Workflow for Control Strategy

Equipped with the complete list of attributes derived from the consolidation, the strategy pivots decisively toward the analytical domain. Novel analytical workflows are initiated, each tailored to assist in selecting analytical technology for a specific quality attribute. This involved outlining the relevant ATP requirements and business drivers, selecting the most accurate technology based on predefined criteria, and ultimately defining the method parameters.


Future Outlook

Aligning product development with a thorough understanding of processes, consolidating information, and implementing analytical workflows will serve as a roadmap for developing vaccines that not only meet but surpass the highest standards of quality and efficacy.

Incorporating automation in the approach highlighted in this blog post led to an expansion of collaboration and broader integration of ValGenesis iRisk throughout the organization. 

With this objective in mind, additional initiatives were introduced to improve the connection between process and analytical information and extend the application of ValGenesis iRisk to other areas, such as assessing risks associated with raw materials.

Looking ahead, there are plans to enhance the analytical methods section on the platform, with a specific focus on knowledge management and an exploration of the platform's potential for expanded corporate usage in the future.



The effective adoption of the digital platform for this approach has yielded numerous benefits for the company, particularly in three areas:

1. Creation of Streamlined Workflows

Integrating a digital tool streamlined traditionally intricate workflows tied to quality risk management. By automating routine tasks and data analysis, these tools alleviated manual efforts and accelerated decision-making, fostering heightened efficiency throughout the pharmaceutical development lifecycle.

2. Improved Knowledge Management

ValGenesis iRisk contributed to simplifying the documentation by creating a centralized repository for all risk management activities, ensuring compliance with regulatory standards, and facilitating seamless audits and inspections.

3. Fostered Collaborative Environment

In the spirit of collaboration, the tool provided a dynamic platform for diverse teams involved in quality risk management. Through cloud-based solutions, stakeholders gain access to and contribute to risk assessments, promoting transparency and a collective approach to addressing potential issues.

This implementation has elevated its approach to vaccine development and paved the way for a new era of precision, efficiency, and risk mitigation.


The opinions, information and conclusions contained within this blog should not be construed as conclusive fact, ValGenesis offering advice, nor as an indication of future results.