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AI Assistant app Overview: Difference between revisions
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Here's a breakdown of the AI Assistant app key functionalities: | Here's a breakdown of the AI Assistant app key functionalities: | ||
'''Trend Analysis and Reports (AI-Analysis-Assistant):''' | |||
* Search through various datasets, such as medical journals, warning letters, SOTA standards, adverse event reports, and regulatory filings. | * Search through various datasets, such as medical journals, warning letters, SOTA standards, adverse event reports, and regulatory filings. | ||
* Gather information from a wide range of sources, such as local files, network drives, user interface, websites, openFDA databases, other public APIs. | * Gather information from a wide range of sources, such as local files, network drives, user interface, websites, openFDA databases, other public APIs. | ||
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* Save and track collected data for in-depth analysis and create reports in various formats including PDF, Word, CSV, XLS, and JPEG. | * Save and track collected data for in-depth analysis and create reports in various formats including PDF, Word, CSV, XLS, and JPEG. | ||
'''Complaint Reportability Estimation (AI-Complaints-Assistant):''' | |||
* Enter complaints through the user interface or upload them directly from Word or PDF files (local or network). | * Enter complaints through the user interface or upload them directly from Word or PDF files (local or network). | ||
* | * AI-powered reportability assessment will estimate the reportability of a complaint based on pre-configured criteria and NLP analysis. | ||
* Clear explanations for reportability estimations, referencing the specific data points used in the evaluation. | * Clear explanations for reportability estimations, referencing the specific data points used in the predictive reportability evaluation. | ||
* Real-time and | * Real-time and batch processing assists with immediate complaint intake processing and retrospective analysis of old complaint data. | ||
'''Risk Assessment Assistant (AI-Risk-Assistant):''' | |||
* Extract | * Extract data from disparate sources to uncover hidden insights about hazards and safety trends related to usability, manufacturing, design, and other key aspects. | ||
* Assistance with estimating the likelihood (P1 and P2) of potential risk scenarios arising from device use. | * Assistance with estimating the likelihood (P1 and P2) of potential risk scenarios arising from device use. | ||
* Assistance with Benefit-Risk Analysis ensuring a clear understanding of potential advantages and drawbacks. | * Assistance with Benefit-Risk Analysis ensuring a clear understanding of potential advantages and drawbacks. | ||
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* Assistance with Process Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA) for design, usability, and process-related risks. | * Assistance with Process Hazard Analysis (PHA) and Failure Mode and Effect Analysis (FMEA) for design, usability, and process-related risks. | ||
The AI Assistant empowers RA and QA professionals to work more efficiently and consider factors from hundreds of thousands of data points, promoting a data-driven approach to premarket regulatory compliance and post market surveillance. | |||
== Getting started == | == Getting started == | ||