skills.rest
HalseyYang
HalseyYangCOMMUNITY
Explore all skills by this author →
GitHub

csv-documentation-generator

Generate GxP-compliant validation documents and traceability matrices for computerized systems.

1|Updated Jul 13, 2026
Search Tags:#document generation#risk assessment#traceability matrix#csv validation#21 cfr part 11#gxp compliance#gamp 5
One-click install
npx skills add https://github.com/HalseyYang/Skills-HY --skill csv-documentation-generator-halseyyang
Or copy as Structured Prompt for Agent▼
Please help me install this Agent Skill.
Skill: csv-documentation-generator
Source: https://github.com/HalseyYang/Skills-HY/tree/main/csv-documentation-generator
Command: npx skills add https://github.com/HalseyYang/Skills-HY --skill csv-documentation-generator-halseyyang

SYSTEM DOCUMENTATION & REQUIREMENTS

💡 This Skill requires python-docx, openpyxl, and includes scripts (resource) and references (resource) components.

What problem does it solve? Creating Computerized System Validation (CSV) documentation for pharmaceutical and medical device systems is slow and error-prone, requiring strict compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11. This Skill automates the generation of bilingual validation documents and maintains full requirements traceability from code to test results. ## Core Features & Use Cases - 12 Validation Document Templates: Generate VP, URS, FS, TS, RA (FMEA), IQ, OQ, PQ, VSR, RTM, checklists, and test cases as Word/Excel files with bilingual Chinese/English support. - Requirements Traceability: Parse @REQ, @TEST, and @RISK markers from source code, link requirements to Git commits and test results, and auto-generate a 14-column traceability matrix. - Compliance Automation: Built-in GAMP 5 category guidance, RPN/FMEA risk analysis, electronic signature detection, audit logging, and CI/CD templates for continuous compliance checks. - Use Case: A QA engineer validating a CTMS system runs the CLI to parse code annotations, then generates a complete validation package (VP through VSR) with an RTM that regulators can audit. ## Quick Start Ask the AI to generate a validation plan for your system, for example: "Generate a GAMP Category 4 validation plan and URS for my CTMS v2.0 clinical trial system."

Frequently Asked Questions about csv-documentation-generator

High-intent search queries and answers about installing and using this skill.

FAQPage Schema
How do I generate CSV validation documents for GxP systems?▼

Run scripts/generate.py with a document type (vp, urs, fs, ra, iq, oq, pq, rtm, vsr, or all), plus --project, --system, --category, and --output arguments. The script auto-creates a virtual environment and produces Word or Excel files.

How to create a requirements traceability matrix from code comments?▼

Annotate code with @REQ URS-xxx, @TEST, and @RISK markers, then run cli.py parse on the source directory. The tool builds requirements.json and generates a 14-column RTM Excel file linking requirements, specifications, and test results.

Does this tool support GAMP 5 and 21 CFR Part 11 compliance?▼

Yes, it includes GAMP 5 Second Edition category guidance, FMEA/RPN risk analysis, automatic electronic signature detection for Part 11, ALCOA+ data integrity checks, and reference documents for GAMP 5, Part 11, and EU Annex 11.

Can I generate validation documents in both Chinese and English?▼

Yes, use --bilingual true with --language zh or en to keep bilingual headers with content in one language, or set --bilingual false for pure single-language output. All 12 templates support both modes.

Why does the script prompt for a GAMP category interactively?▼

When --category is omitted, the script shows a bilingual GAMP 5 category selection menu. To run non-interactively, always pass --category 1-5 or use --auto-add flags so AI agents can execute without stdin.

What are the limitations of automated validation document generation?▼

Template requirements are examples that must be reviewed and customized for real systems. The tool assists documentation but does not replace human risk judgment, supplier assessment decisions, or regulatory review of final documents.

Related Skills

Explore More Legal & Compliance Skills→
fartybobofartybobo
4

plan-task

Collect requirements and create implementation plans for software changes.

Official
Advanced
SJTU-IPADSSJTU-IPADS
7

quality-documentation-manager

Automate compliant quality documentation for medical devices with version control and audit trails.

Official
Advanced
nroze22nroze22
1

validation-protocol

Generate IQ, OQ, and PQ validation protocols for EDC systems.

Community
Advanced
AcosmiAcosmi
6

remote-approval-config

Manage remote approval configurations across Feishu, DingTalk, and WeCom.

Community
Advanced