Integrating process data with risk management can trigger many improvement opportunities and competitive advantages. In this blog post, we’ll look at the three main benefits of doing so, and how this integration can increase the efficiency and competitiveness of your organization.
#1 Reducing the Subjectivity of Risk Assessments
The first key benefit is the reduction of subjectivity in risk assessments.
As in any other human decision, subjectivity in quality risk management (QRM) can impact the outcome of its activities and the way you conduct the exercise itself. Trying to reduce this impact has been on regulators’ radar in an attempt to increase the robustness of QRM and the established control strategies to ensure product quality and patient safety.
As ICH Q9 (R1) points out, subjectivity cannot be eliminated, but it should be acknowledged and addressed to limit the impact of human bias and behavioral factors when making decisions.
This can be achieved by increasing the sources and amount of available information, data, and science-based knowledge. Applying this knowledge base to risk assessment exercises will decrease the likelihood of user bias.
If you'd like to know more, you can read our blog post about reducing the subjectivity of risk assessments.
#2 Significantly Automating the QRM Process
Digitizing the integration of process data with a risk management platform can promote the identification of potential risks in real time and, consequently, be a trigger to strengthen controls, reduce errors, and improve efficiency.When you collect and analyze process data, it becomes a valuable input for risk assessment activities and serves as a catalyst for achieving the following gains:
- Improving the efficiency of the QRM process by reporting incidents faster.
- Upgrading QRM to a growable and scalable operation that is less limited by the available human resources.
- Gaining visibility of process trends earlier, facilitating the implementation of risk mitigation actions.
- Streamlining and automating risk analysis and reporting.
#3 Optimizing Post-Approval Change Management
Another key benefit of integrating process data with risk management activities is related to the optimization of Post-Approval Change Management (PACM) Protocols. (1)
Having an optimized and streamlined PACM Protocol can have many benefits, such as:
- Predictability and transparency of the requirements and studies needed to implement a change.
- A lower reporting category when implementing changes with shorter review timelines.
- Prospective agreements between you and the regulator.
The first step to applying a PACM Protocol requires the submission of the protocol that includes the risk management activities. When you integrate process data with risk management activities, you can perform these risk management activities using a systematic data-driven approach. This results in a more consistent, higher-quality evaluation and decision-making process.
To learn more about integrating risk and process knowledge over the lifecycle, read our Industry Insight: Risk and Data as Knowledge Enablers - a Lifecycle Approach.
If you're curious about ICH Q12 and how to create a PACM Protocol, read this blog post.
How to Integrate Process Data with Risk Management
To successfully integrate and implement a data-driven QRM process, two essential prerequisites must be met: a digital risk management platform and a digital platform that effectively handles manufacturing process intelligence and can gather data from multiple sources, such as a digital Continued Process Verification (CPV) Plan.
This digital risk management platform should:
- Easily map out quality attributes, process parameters, and operations for all product lifecycle stages.
- Evaluate, mitigate, and design robust control strategies aligned with QbD practices.
- Perform cross-area and cross-site assessments, including cross-contamination, systematically.
ValGenesis offers unparalleled support in this field with our comprehensive digital risk management tool. Additionally, ValGenesis Process Insight simplifies the implementation of digital CPV Plans. Please contact one of our experts to find a solution tailored to your needs.
Sources
- “ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Life Cycle Management - Scientific Guideline ”, ema.europa.eu. Accessed on July 18, 2023.
