Gxpcode Regulatory Guide Analysis
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About this skill
Problem It Solves
Regulatory and guideline documents in pharma can be dense, cross-referenced, and easy to misread. Gxpcode Regulatory Guide Analysis turns file parsing, domain judgment, and structured interpretation into a fixed workflow, helping engineers or compliance readers understand how to present a regulation for training or sharing.
How It Works
- Input validation: accepts only
PDF,DOCX,DOC, andTXT; other formats stop the run. - Output mode: asks for
A. Training demoorB. Learning share, then generates only that variant. - Pipeline: runs input conversion, reading, domain judgment, regulation analysis,
HTMLgeneration, and output conversion; step details live inresources/steps/. - Analysis assets:
Step 4uses subtask prompts fromresources/prompts/;Step 5followsresources/layouts.mdandresources/html_spec.mdfor layout.
Boundaries
The skill favors a stable process over free-form output. It is not meant for non-regulatory materials, and users should verify language, version, and jurisdiction before relying on the summary. The output should not be treated as legal advice.
Use Cases
- A regulatory specialist converts a PDF GMP guideline into a training demo and asks for a structured HTML reading brief.
- A study team uses a DOCX ICH guideline in learning-share mode to review scope, key obligations, and discussion points.
- A compliance trainer prepares a TXT regulation excerpt for a demo and requests domain judgment plus HTML presentation pages first.
- A QA engineer checks a newly released regulation file, confirms supported format, and generates a team review A/B briefing note.
Best For
- Pharma compliance trainers who need to turn PDF or DOCX guidelines into training demo materials.
- Regulatory affairs specialists who need to interpret DOCX or TXT regulation excerpts into learning-share discussion points.
- QA/RA engineers who need to review regulatory files with supported-format checks and structured HTML explanations.
- Compliance study-group leads who need A/B output modes to turn regulatory points into a fixed presentation layout.
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