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PharmTech.com Quality and Regulatory Sourcebook eBook March 2024 Pharmaceutical Technology ® 27 Qualit y by Design and FMECA [2]), fault tree analysis (F TA), hazard analysis and critical control points (HACCP), hazard operability analysis (HAZOP), and preliminary haz- ard analysis (PHA). FMEA, in particular, is a widely used tool for identif ying, assessing, and analyzing risks used to prioritize work packages to ensure the development of safe and effective medicines. Trad it ion a l r i sk a ssessment work f lows u si ng spreadsheets or word-processors can be laborious and have limited capacity to connect with the vast vol- umes of data generated by organizations, including product specific understanding. This leads to chal- lenges with leveraging prior knowledge (3), which in turn can result in unwanted inconsistencies between risk assessments for a single product or across multi- ple products of the same modality. While these risk assessments are acknowledged for their inherent value, they are limited in scalability and susceptible to human errors. The resource-intensive nature of these assessments results in the generation of large datasets that prove complex to maintain and ana- lyze using traditional techniques, leading to knowl- edge silos. In response to the evolving landscape, pharmaceu- tical companies have developed risk assessments em- bedded with prior knowledge, often stored in a col- lection of spreadsheets and written report templates. However, these encounter the same challenges that extend beyond their effectiveness, posing limitations on knowledge sharing. The current paradigm of risk assessments operating primarily in this traditional, siloed, unintegrated format results in significant challenges associated with collaborative risk man- agement across disciplines, groups, and even regula- tory agencies, making the need for a more integrated and collaborative digital approach evident. The implementation of digital tools (6), utilizing smart technologies such as robotics, artificial intel- ligence, automation, and data analytics, is deemed essential to meet the growing demand for the acceler- ated delivery of medicines in an ever-changing global market (7,8). Digitalization of pharmaceutical sys- tems, including QbD risk assessments, is positioned as a valuable strategy to address the challenges of drug substance and product development. By em- bracing the capabilities of smart technologies, the pharmaceutical industry can enhance QbD product and analytical procedure development as outlined in ICH Q2, Q8–12, and Q14 (9) leading to consistent implementation of these guidelines. A digital platform designed to facilitate risk as- sessments within a wider digital ecosystem (includ- ing digitalization of other QbD and product devel- opment processes) holds the potential to expedite the overall dr ug development process and enable predictive analytics (Figure 1). This alignment not only highlights the positive outcomes associated with digital risk assessment platforms but also po- sitions them as a strategic imperative in the contem- porar y landscape of pharmaceutical development. FIGURE 1. High-level representation of quality-by-design (QbD) digitization goals and benefits. Figures are courtesy of the authors