Identifying Data Integrity Hotspots Using AI Technology

In part 2 of a 2-part interview,Susan Schniepp, Regulatory Compliance Associates Inc., discusses the evolving relationship between AI and human oversight. She highlights how emerging technologies, such as digital twins, are transforming traditional manufacturing and validation processes, as a part of PDA Week 2026.

Schniepp explains that AI can significantly streamline operations by acting as a highly efficient data aggregator. Rather than requiring a person to manually hunt through disparate files, the technology centralizes information to provide a comprehensive overview of a batch. She observes, "it's compiling all of this information coming at it like one big centralized brain and then saying, 'All of these things related, and there were no deviations.’” This centralized brain allows for the creation of a batch dossier that summarizes parameters and deviations, greatly speeding up the timeline for product release.

The technology also serves as a proactive tool for quality assurance. By analyzing vast amounts of data, AI can pinpoint specific areas where errors are likely to occur. Schniepp notes, "As you put AI in, it's gonna identify places where there, is potential for data integrity." Once these hotspots are identified, humans can take action to shore up the system and prevent actual violations from happening.

Schniepp advocates for a human-in-the-loop model. While machines are capable of learning faster and absorbing more data than humans, she emphasizes that the human professional must remain the final decision-maker. The human's role is to absorb the data provided by the digital twin and AI to make the final call on whether a batch is safe for release, ensuring accountability in a complex and high-stakes industry.