Invention Grant
- Patent Title: Methods and systems for regulatory intelligence
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Application No.: US16529790Application Date: 2019-08-02
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Publication No.: US11061959B2Publication Date: 2021-07-13
- Inventor: Raj Kumar Gulati
- Applicant: Raj Kumar Gulati
- Applicant Address: US IN Fishers
- Assignee: Raj Kumar Gulati
- Current Assignee: Raj Kumar Gulati
- Current Assignee Address: US IN Fishers
- Main IPC: G06F16/635
- IPC: G06F16/635 ; G06F16/953 ; G06F16/638 ; G06F16/61

Abstract:
Methods and systems are described for collecting, processing, classifying, structuring, transforming, relating, creating & linking audio recordings and reporting filtered data related to US FDA Warning Letters and Individual Citations for users to get regulatory intelligence from a database. Data is collected from multiple sources including FDA website. Individual Citations are parsed, isolated from their parent Warning Letters and subclassified to enable meaningful searches for users to assess regulatory compliance risks. Single topic records are created for each Individual Citation that is related to its corresponding Product Type, System, FDA Guidance for industry, Inspector name, 21 CFR section, Country, Company and Date of Warning Letter. Audio recordings are created for Individual Citations and Individual Warning Letter contents for listening purposes and integrated with the database. The system allows searches at two levels, one related to ‘Individual Warning Letters’, and two, for ‘Individual Citations’. The system also helps users to analyze aggregate trends and metrics. Records are made accessible through a database on webserver upon user's request from a desktop, a mobile computing device or like devices via a graphical user interface.
Public/Granted literature
- US20190354551A1 METHODS AND SYSTEMS FOR REGULATORY INTELLIGENCE Public/Granted day:2019-11-21
Information query