GxpCode Global Regulatory Guidance Auto-Tracking
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About this skill
Problem
Regulatory and guidance updates for pharma products are scattered across agency sites. Manual monitoring can miss new, revised, or withdrawn documents, and it is hard to judge whether a file affects the company's products.
GxpCode targets regulatory tracking and turns "find documents, diff changes, fetch details, tag content, and report" into a repeatable pipeline.
How It Works
The skill uses config.yaml, sources.yaml, and history.json as state, producing intermediate JSON files and .done markers:
- Source detection: reads RSS or Web sources and extracts candidate regulatory or guidance items.
- Change comparison: uses the history store to identify new, revised, withdrawn, and similar status changes.
- Detail fetching: retrieves full text and PDF attachments into the current workspace.
- Analysis and tagging: summarizes items, assigns tags, and assesses relevance to the configured products.
- Reporting and notification: generates dated Markdown and PDF tracking reports, then updates history.
Branch capabilities include parser matching for new regulatory source URLs and a source management panel triggered by keywords to adjust sources.yaml. Execution constraints emphasize fault tolerance: a single source or item can be skipped, while only a FATAL failure stops the full pipeline.
Scope: the skill is oriented toward ongoing pharma regulatory and guidance tracking, not a full compliance audit. PDF output and tracking data paths follow workspace conventions, and first-time use requires initialization.
Use Cases
- QA checks agency sites weekly to capture newly issued or revised guidance and archive summaries.
- Regulatory specialists add a new source URL so later runs fetch updates from that site.
- Product compliance engineers assess whether a withdrawn guidance affects the current filing and produce a PDF report.
- The team disables broken RSS sources in the source panel to avoid repeated failed items in weekly reports.
Best For
- Pharma QA leads: need to monitor multiple agency updates without missing new, revised, or withdrawn items.
- Regulatory affairs specialists: need to turn scattered official site changes into traceable summaries and PDF reports.
- Product compliance engineers: want to judge whether a guidance item affects company products and tag relevance.
- Automation engineers: need to manage RSS/Web sources and handle single-source failures in tracked runs.
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