AI-generated from publicly available materials.Researchers from the University of Limerick highlight a significant gap in digital validation processes within the pharmaceutical manufacturing sector, proposing a risk-based workflow to bridge this divide.
The study points out that the disconnect between traditional validation methods and advanced digital strategies is not primarily a regulatory issue. Instead, it stems from the challenge of effectively integrating risk-based validation principles into everyday engineering practices. Dermot McMorrow, a key researcher, emphasizes that while guidance encourages automation and critical thinking, validation often remains a fragmented, document-centric process that does not align with engineering development.
The team developed a model predictive controller for regulating pH levels, utilizing a data-driven approach to enhance controller tuning and prioritize relevant failure modes. This innovative workflow aims to unify process understanding, quality risk management, and verification activities throughout the engineering lifecycle, allowing for real-time evidence generation as systems are developed. This holistic approach not only improves traceability from risks to verification but also facilitates more efficient validation processes, potentially overcoming barriers to continuous system enhancements.
Implementing this new workflow in regulated environments requires a cautious, iterative approach, taking into account the maturity of innovations and organizational readiness. The researchers found that their model-based design significantly alleviated common digital validation challenges, streamlining compliance and enhancing traceability. However, they caution that any adoption of this framework must be tailored to fit within existing quality systems and regulatory contexts, marking it as a proof-of-concept rather than an immediate solution for deployment.