AI-Assisted Systematic Review and Validation of Analytical Worksheets
Description
Manual review and validation of analytical worksheets can create bottlenecks in regulatory processes, introduces potential human error, and limits scalability of quality assurance procedures across FDA operations. Analytical worksheets serve as critical evidence in legal proceedings, enforcement actions, and regulatory decisions affecting public health and safety. These worksheets are the legal documents that will be used and referenced in a court of law and legal proceedings if FDA determines regulatory action should be taken in accordance with the Federal Food, Drug, and Cosmetic Act and subsequent amending supplements codified in Title 21of the United States Code.
Detailed example
Assessment summaries identifying errors and inconsistencies in court-admissible documents
AI / analytics pattern
Classical/Predictive Machine Learning: Models trained on data to make predictions or classifications based on identified patterns or relationships.
Automation level / stage
a) Pre-deployment – The use case is in a development or acquisition status.
Expected benefit
Increased efficiency in worksheet validation processes, standardized review procedures ensuring consistency in legal documents, faster turnaround times for analytical work supporting enforcement actions, enhanced quality assurance for evidence used in court, reduced human error in legally significant documents, and improved consistency in regulatory processes supporting FDA's mission to protect public health.
Controls / human review
ATO: Not reported; PIA: Not published