Quality Surveillance Dashboard (QSD)
Description
Need for consistent, data-driven assessment of drug manufacturing facilities and proactive detection of potential quality signals that could indicate problems with drug safety or effectiveness.
Detailed example
Identifies and extracts keywords/phrases from unstructured documents and presents sentences containing keywords/phrases in context.
AI / analytics pattern
Natural Language Processing: AI that processes, interprets, and shares information in human language.
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
Extracts unstructured text from documents and pools that with other available data to form a dashboard that enables consistent assessment of Center for Drug Evaluation and Research (CDER) regulated manufacturing facilities, supporting FDA's oversight of drug quality.
Controls / human review
ATO: Yes; PIA: Not published
Data needed
FDA EIR documents