Identifying Data Integrity Hotspots Using AI Technology

Data Integrity Hotspots

As artificial intelligence and digital twins become more integrated into pharmaceutical manufacturing and validation, they are creating new opportunities to improve efficiency, strengthen quality oversight, and accelerate decision making. In this second part of a two part interview, Susan Schniepp of Regulatory Compliance Associates discusses how these technologies can transform traditional manufacturing processes while maintaining an essential role for human expertise.

AI can serve as a centralized data aggregator, bringing information from multiple sources together to provide a comprehensive view of a manufacturing batch. By connecting process parameters, deviations, and other relevant information, the technology can help generate a batch dossier and accelerate the product release process. AI can also analyze large volumes of data to identify areas where data integrity risks may exist, allowing quality professionals to address potential vulnerabilities before they become actual compliance issues.

Schniepp emphasizes that these capabilities should complement rather than replace human decision making. A human in the loop remains essential for evaluating the information generated by AI and digital twins and making the final determination on whether a batch is suitable for release. This approach combines the speed and data processing capabilities of emerging technologies with the professional judgment and accountability required in a highly regulated pharmaceutical environment.

Read the full article: Digital Twins and the Future of Pharma Validation, Part 2