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16 BioPharm International ® Quality and Regulatory Sourcebook eBook March 2024 www.biopharminternational.com Quality by Design author the next deliverable in the sequence. This is es- pecially true in the case of QbD risk assessments, where leveraging platform and prior knowledge is key not only to efficiently complete the task, but also to applying the appropriate level of technical rigor by considering the en- tire body of data in a product portfolio. Too often this es- sential prior knowledge is housed in disparate databases and separate reports in suboptimal document manage- ment systems. Additionally, each input from one data source to a spreadsheet or document represents a man- ual transcription, which in turn requires a check prior to approval and publication to ensure good pharmaceu- tical practices (GxP) control. The data transcription and checking process represents a major time commitment for CMC project teams and often corresponds with the end of a product lifecycle phase or major CMC activity (e.g., pre-process qualification, pre-submission) where resources are already constrained. The data flow associated with a digital risk assessment platform, especially when integrated within a CMC digital ecosystem (Figure 3), addresses these inefficiencies and limitations by streamlining the data flows within a com- mon platform. All product and process definition inputs, along with relevant platform development data and prior knowledge, are fed into the platform and routed to the relevant assessments therein. Data flows automatically between assessments without the need for manual inter- vention. This not only enables CMC project team members to focus more directly on identification and discharging technical risks, but also represents a major time savings by removing the need for multiple transcription checks. En- hanced understanding of intra- and inter-project risks can also be achieved using built-in risk visualization tools in digital systems such as iRISK. Figure 4 presents a risk heat map and process risk mapping for an example biophar- maceutical drug substance "A-Mab". These visualizations highlight areas of key focus for further development work and mitigation strategy. It is essential to note here that data standards that are necessary for use of a digital risk management platform will breakdown data silos, a well-known challenge not only with risk assessments but with many processes in the pharmaceutical industry. More specifically, common data standards are required to enable the efficient querying of platform and prior knowledge from a database, as well as cross-product summary analyses of risk assessment out- puts. In this sense, digital risk assessment platforms also help enforce and maintain data standards by driving their structured implementation. This much needed structur- ization of data aligns directly with FDA's quality assess- FIGURE 3. Enhanced digital quality-by-design (QbD) data flow and digital chemistry, manufacturing, and controls (CMC) ecosystem (simplified).