Renamed: 356H Machine Learning (ML) Facility Supply Chain Role Classification Previously: 356H ML Facility Supply Chain Role Classification
Description
Manual classification of facility supply chain roles from FDA industry submissions (356h forms) is time-consuming and inefficient
Detailed example
Extracts a facility's supply chain role from industry submissions and displays identified roles on a data-stewards screen for human verification and final determination.
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
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Improve the efficiency of evaluating 356H forms to assess a facility's supply chain role, thereby decreasing the time required for the processing of submissions and enabling faster oversight of drug manufacturing facilities.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
Applicant submissions