csv-documentation-generator
Use when generating computer system validation (CSV) documentation for pharmaceutical and medical device industries, including validation plans, URS, FS, IQ/OQ/PQ documents, and traceability matrices.
Best for Pharma CSV engineersWorks with GitHubHigh risk
⌘source
- author
@LeoYeAI- language
- Python
★2kstars
306forks
May 6, 2026
✦overview.md
Key Features
- ·Generates CSV validation documents
- ·Supports validation plans, URS, FS, IQ/OQ/PQ
- ·Includes traceability matrices
- ·Handles bilingual output (Chinese/English)
- ·Compatible with GAMP 5 categories
- ·Outputs to specified directory
Use Cases
- →Creating IQ/OQ/PQ protocols for a new laboratory system
- →Generating a full validation set for a GxP-compliant application
- →Producing a traceability matrix for a 21 CFR Part 11 audit
- →Drafting a validation plan for a medical device software upgrade
Best for
- ✓Pharma CSV engineers
- ✓Medical device QA teams
- ✓GxP validation projects
Not ideal for
- !Non-regulated software
- !Agile development teams
- !One-off documentation tasks
FAQs
name
csv-documentation-generator
description
Use when generating computer system validation (CSV) documentation for pharmaceutical and medical device industries, including validation plans, URS, FS, IQ/OQ/PQ documents, and traceability matrices.
triggers:["Generate CSV documentation","创建 GMP 验证文档","计算机化系统验证","IQ OQ PQ protocol","URS FS RA 追溯矩阵","GAMP 5 validation","GxP","21 CFR Part 11","电子签名","电子记录","EDC","CTMS","eTMF","LIMS","医疗器械"]
category:gxp-compliance
version:1.6.4
author:zealot00
homepage:https://github.com/zealot00/csv-documentation-generator
repository:https://github.com/zealot00/csv-documentation-generator
bugs:https://github.com/zealot00/csv-documentation-generator/issues
createdAt:2026-03-18
lastReviewedAt:2026-03-18
validationStatus:beta
compatibility:{"openclaw":">=1.0.0","python":">=3.10"}
requiredTools:["exec","write"]
inputSchema:{"type":"object","required":["project","system"],"properties":{"docType":{"type":"string","enum":["vp","urs","fs","ra","iq","oq","pq","rtm","vsr","checklist","test-case","all"]},"project":{"type":"string","description":"项目名称 / Project name"},"system":{"type":"string","description":"系统名称及版本 / System name and version"},"category":{"type":"integer","enum":[1,2,3,4,5],"description":"GAMP category (1-5)"},"bilingual":{"type":"boolean","default":true},"output":{"type":"string","default":"./output"}}}
outputSchema:{"type":"object","properties":{"docx":{"type":"array","items":{"type":"string"},"description":"Generated Word documents"},"xlsx":{"type":"array","items":{"type":"string"},"description":"Generated Excel documents"}}}
CSV Documentation Generator
Generate Computerized System Validation (CSV) documentation for pharmaceutical and medical device industries. Supports bilingual (Chinese/English) templates and multiple output formats (Word/Excel).
When to Use
Use this skill when:
- Creating validation documentation for GMP-regulated systems
- Generating User Requirements Specification (URS) with regulatory compliance checks
- Preparing IQ/OQ/PQ protocols for system qualification
- Creating traceability matrices linking requirements to test cases
- Conducting risk assessments for computerised systems
- Need documentation templates that comply with GAMP 5, 21 CFR Part 11, EU Annex 11
Supported Systems
| System Type | GAMP Category | Documents |
|---|---|---|
| EDC (Electronic Data Capture) | Category 4/5 | All 12 documents |
| CTMS (Clinical Trial Management) | Category 4 | VP, URS, FS, RA, IQ, OQ, RTM |
| LIMS (Laboratory Information Management) | Category 4/5 | All 12 documents |
| MES (Manufacturing Execution System) | Category 4 | All 12 documents |
| ERP (Enterprise Resource Planning) | Category 4 | VP, URS, RA, IQ, OQ |
$install
1-click copynpx skills add LeoYeAI/openclaw-master-skills --skill csv-documentation-generatorSafety assessment
★
Clarity score
How clear and easy to understand the SKILL.md instructions are, rated from 1 to 5.
4/ 5
very goodClear and well structured, with only minor parts that might need a second read.
◎
Actionability score
How directly an agent can act on the SKILL.md instructions, rated from 1 to 5.
4/ 5
highMostly actionable with clear steps; only a few small gaps remain.