Agent skill

CSV Documentation Generator

by LeoYeAI in LeoYeAI/openclaw-master-skills

A skill your agent uses when generating computer system validation (CSV) documentation for pharmaceutical and medical device industries, including validation plans, URS, FS, IQ/OQ/PQ documents, and…

MITAuto-check passedDocuments & Office

Install CSV Documentation Generator

skills CLI
$ npx skills add LeoYeAI/openclaw-master-skills --skill csv-documentation-generator -a claude-code

Project install by default; add -g for ~/.claude/skills/.

GitHub CLI
$ gh skill install LeoYeAI/openclaw-master-skills csv-documentation-generator --agent claude-code

Project scope by default; add --scope user for a personal install. Needs GitHub CLI 2.90.0 or later (public preview).

Manual copy
$ git clone --depth 1 https://github.com/LeoYeAI/openclaw-master-skills.git skills-src && mkdir -p .claude/skills && cp -r skills-src/skills/csv-documentation-generator .claude/skills/csv-documentation-generator && rm -rf skills-src

Use ~/.claude/skills/ instead of .claude/skills for a personal install. The folder must contain SKILL.md.

Claude Code skills documentation · loads skills from .claude/skills/

Facts

Skill name
csv-documentation-generator
GitHub stars
2.2k
Token cost
~6.6k tokens
SKILL.md length
1,787 words
Files
68 (incl. scripts, references)
Skills in repo
972
Repo updated
First seen
Licence
MIT

At a glance

A skill your agent uses when generating computer system validation (CSV) documentation for pharmaceutical and medical device industries, including validation plans, URS, FS, IQ/OQ/PQ documents, and…

  • Works in 3 steps: First run: Automatically creates .venv… → Dependencies: Automatically installs… → Subsequent runs: Use the already-created…
  • Generating computer system validation (CSV) documentation for pharmaceutical and medical device industries
  • SKILL.md covers When to Use, Quick Start, Available Commands and Command Options, plus 9 more sections
  • Runs Python scripts from its folder; calls python3 and pip

What it does

CSV Documentation Generator is an agent skill from LeoYeAI/openclaw-master-skills. 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.

Its SKILL.md is about 6.6k tokens, which your agent loads only when the skill is triggered. The skill folder holds 69 other files, including scripts and reference files (for example `.csv-docs-config.json`, `CHANGELOG.md` and `CHANGELOG_en.md`). Compatibility notes: {"openclaw":"=1.0.0","python":"=3.10"}

It sits in Documents & Office, covering CSV and tabular files and Technical documentation. The repository describes itself as: 🧠 Curated collection of 1209+ best OpenClaw skills — weekly updated by MyClaw.ai. The licence is MIT.

When your agent uses it

  • Generating computer system validation (CSV) documentation for pharmaceutical and medical device industries
  • Including validation plans
  • IQ/OQ/PQ documents
  • Traceability matrices

Example prompts

  • “/csv-documentation-generator”

Requirements

  • Python 3
  • Compatibility (from SKILL.md): {"openclaw":">=1.0.0","python":">=3.10"}

Workflow steps

3 steps, taken from the first numbered list in SKILL.md.

  1. First run: Automatically creates .venv virtual environment in skill directory
  2. Dependencies: Automatically installs required packages (python-docx, openpyxl, etc.)
  3. Subsequent runs: Use the already-created virtual environment

What it can do on your machine

Read from SKILL.md and the folder at commit e5199b5. It shows what the files ask for, not the result of running them.

  • Tool permissions

    Pre-approves nothing: there is no allowed-tools line, so your agent's usual permission prompts apply.

    From allowed-tools in the SKILL.md frontmatter.

  • Runs code

    Ships 3 files in scripts/ (Python, from the files we listed), which the agent can run.

    Shell commands in SKILL.md call:

    • python3
    • pip

    From the folder's file list and the shell code blocks in SKILL.md.

  • Network

    No URLs in SKILL.md. Its commands use pip, which can reach the network depending on how they are called.

    From URLs in SKILL.md, links to its own repository left out.

  • Credentials

    Names no API keys, tokens, secrets or passwords.

    From names ending in _API_KEY, _TOKEN, _SECRET, _KEY or _PASSWORD in SKILL.md.

  • Compatibility

    {"openclaw":">=1.0.0","python":">=3.10"}

    From compatibility in the SKILL.md frontmatter.

Context cost

CSV Documentation Generator loads about 6.6k tokens when it runs, and up to ~10k if it reads all its reference files. Until then it costs about 57 tokens; SKILL.md has 1,787 words of instructions outside code blocks.

Always · name and description, kept in context so the agent knows when to use it
~57
When it runs · the whole SKILL.md, loaded when a task matches
~6.6k
With references · SKILL.md plus every file in references/, read only if the agent opens them
~10k

Estimates: characters ÷ 4, the usual rule of thumb; real counts depend on the model's tokenizer. Scripts and assets cost tokens only if the agent reads them.

Safety

Auto-check passed

The automated check found no risky patterns in SKILL.md.

Automated static check — not a guarantee. Review scripts before installing. It scans the text of SKILL.md for risky patterns (piping downloads into a shell, reading credential files, hidden Unicode, destructive commands); the scripts in this folder are not scanned.

SKILL.md

The full file from LeoYeAI/openclaw-master-skills at commit e5199b5, republished under its MIT licence (© LeoYeAI). 1,787 words, ~6,581 tokens.

Download SKILL.mdSave it as .claude/skills/csv-documentation-generator/SKILL.md (or your agent's skills folder). This skill also uses 67 other files; get the full folder from GitHub.
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.
compatibility
{"openclaw":">=1.0.0","python":">=3.10"}
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…
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

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 TypeGAMP CategoryDocuments
EDC (Electronic Data Capture)Category 4/5All 12 documents
CTMS (Clinical Trial Management)Category 4VP, URS, FS, RA, IQ, OQ, RTM
LIMS (Laboratory Information Management)Category 4/5All 12 documents
MES (Manufacturing Execution System)Category 4All 12 documents
ERP (Enterprise Resource Planning)Category 4VP, URS, RA, IQ, OQ
SCADA/DCSCategory 2/3VP, URS, IQ, OQ, PQ
Custom SoftwareCategory 3/4VP, URS, RA, IQ, OQ

Quick Start

bash
# Navigate to skill directory
cd <SKILL_DIR>/csv-documentation-generator

# Run script - will automatically create virtual environment on first run
python3 scripts/generate.py vp --project "XX系统" --system "EDC v1.0" --output ./output/

# Note: If --category is not specified, interactive GAMP category selection will be prompted
# The script provides bilingual (Chinese/English) guidance based on GAMP 5 Second Edition

# Generate Validation Plan (with category specified)
python3 scripts/generate.py vp --project "XX系统" --system "EDC v1.0" --category 4 --output ./output/

# Generate full validation package
python3 scripts/generate.py all --project "XX系统" --system "MES" --category 4 --output ./validation/
Parse Requirements from Code (pre-generation)
bash
# Navigate to skill directory
cd <SKILL_DIR>/csv-documentation-generator

# Parse source code for requirements (extracts @URS, @TEST, @FS, @TS markers)
python3 scripts/cli.py parse ./src

# For AI agents (non-interactive mode), use --auto-add:
python3 scripts/cli.py parse ./src --auto-add

# Review extracted requirements
cat requirements.json
Auto Environment Setup

This skill automatically handles environment setup:

  1. First run: Automatically creates .venv virtual environment in skill directory
  2. Dependencies: Automatically installs required packages (python-docx, openpyxl, etc.)
  3. Subsequent runs: Use the already-created virtual environment

This ensures consistent behavior and avoids dependency conflicts.

Interactive GAMP Category Selection

If --category is not specified, the script will prompt with bilingual (Chinese/English) guidance:

GAMP 5 (Second Edition) Category Selection:
  [1] Infrastructure Software - 基础设施软件
  [2] Firmware - 固件
  [3] Commercial Off-The-Shelf (COTS) - Non-configured - 商用现货软件 (不可配置)
  [4] Configured COTS - 配置型 COTS 软件 (e.g., EDC, CTMS, LIMS, MES)
  [5] Custom / Critical Application - 定制/关键应用

AI agents should guide users to select the appropriate category based on GAMP 5 Second Edition principles.

Available Commands

CommandDescriptionOutput Format
generate.py vpValidation Plan.docx
generate.py ursUser Requirements Specification.docx
generate.py fsFunctional Specification.docx
generate.py tsTechnical Specification.docx
generate.py raRisk Assessment (FMEA).docx
generate.py iqInstallation Qualification.docx
generate.py oqOperational Qualification.docx
generate.py pqPerformance Qualification.docx
generate.py rtmTraceability Matrix.xlsx
generate.py vsrValidation Summary Report.docx
generate.py checklistValidation Checklist.xlsx
generate.py test-caseTest Case Template.xlsx
generate.py allFull validation package.docx / .xlsx

Command Options

OptionDescriptionRequired
--projectProject nameYes
--systemSystem name and versionYes
--categoryGAMP category (1-5). If not specified, interactive selection will be prompted with bilingual GAMP 5 guidance.No (will prompt)
--bilingualEnable bilingual mode: 'true' or 'false' (default: true). When true, headers remain bilingual and content follows --language.No
--languagePrimary language for content: 'zh' (Chinese) or 'en' (English) (default: zh). Used when bilingual=false or for content in bilingual mode.No
--verbose / -vShow detailed progress information (default: simplified output)No
--outputOutput directoryYes
--formatOutput format: docx, xlsx, or both (default: both)No

Output Format Standards

All generated documents follow consistent naming and formatting rules:

Document Naming Convention
Document TypeFormatExample
Validation Plan{TYPE}_{PROJECT}.{ext}VP_XX系统.docx
User Requirements{TYPE}_{PROJECT}.{ext}URS_XX系统.docx
Functional Specification{TYPE}_{PROJECT}.{ext}FS_XX系统.docx
Traceability MatrixRTM_{PROJECT}.{ext}RTM_XX系统.xlsx
Output Directory Structure
{output_dir}/
├── VP_项目名.docx
├── URS_项目名.docx
├── FS_项目名.docx
├── TS_项目名.docx
├── RA_项目名.docx
├── IQ_项目名.docx
├── OQ_项目名.docx
├── PQ_项目名.docx
├── VSR_项目名.docx
├── RTM_项目名.xlsx
└── CHECKLIST_项目名.xlsx
Document Styling Standards

Fonts:

  • Chinese text: SimSun (宋体)
  • English text: Arial

Colors:

  • Table headers: #2563EB (Royal Blue) with white text
  • Priority markers: [必须] (red), [应该] (amber), [可以] (green)
  • Test results: [通过] (green), [失败] (red), [待测] (amber)

Template Variables

Common variables used in templates:

VariableDescriptionExample
{PROJECT_NAME}Project name临床试验系统
{SYSTEM_NAME}System nameEDC v1.0
{SYSTEM_VERSION}System version1.0
{GAMP_CATEGORY}GAMP category4
{DOC_ID}Document IDURS-001
{DATE}Document date2024-01-01
{AUTHOR}Document author张三
{REVIEWER}Reviewer name李四
{APPROVER}Approver name王五

Regulatory Compliance

GAMP 5 Categories
CategoryDescriptionValidation Approach
1Operating SystemLegacy
2FirmwareSimplified
3Commercial-off-the-shelf (COTS)Risk-based
4Configured COTSRisk-based
5Custom/CriticalFull validation
Key Regulatory Requirements

This skill includes compliance checks for:

  • 21 CFR Part 11: Electronic Records and Signatures

    • Audit trail requirements
    • Electronic signature requirements
    • System access controls
  • EU Annex 11: Computerised Systems

    • Validation requirements
    • Data integrity
    • Change control
  • ALCOA+: Data Integrity

    • Attributable
    • Legible
    • Contemporaneous
    • Original
    • Accurate (+ Complete, Consistent, Enduring)

Semantic Action Graph

This skill encapsulates the following semantic actions for GxP document generation:

Action Graph
parse_requirements(source_path) → RequirementsDB
    │
    ▼
generate_vp(context) → Document
    │ ──────────────────────► generate_urs(context) → Document
    │                                           │
    │ ◄── (URS traceability) ──────────────────┤
    │                                           ▼
    ├────────────────────────────────────► generate_fs(context) → Document
    │                                           │
    │ ◄── (FS technical specs) ─────────────────┤
    │                                           ▼
    └────────────────────────────────────► generate_ra(context) → Document
                                                    │
                                        ┌───────────┴───────────┐
                                        ▼                       ▼
                              generate_iq_oq_pq(context)   generate_rtm(context)
                                        │                       │
                                        └───────────┬───────────┘
                                                    ▼
                                        generate_vsr(context) → Document
Semantic Actions
ActionDescriptionPre-conditions
parse_requirements()Parse @URS, @FS, @TEST markers from source codeSource code available
generate_vp()Create Validation PlanProject name, system name, GAMP category
generate_urs()Create User Requirements SpecificationSystem context, GxP scope
generate_fs()Create Functional SpecificationURS requirements linked
generate_ra()Create Risk AssessmentURS priorities, GxP scope
generate_iq_oq_pq()Create Qualification ProtocolsRA risk levels, TS config
generate_rtm()Create Traceability MatrixURS, FS, test cases linked
generate_vsr()Create Validation Summary ReportAll test results, deviations
sync_bidirectional()Sync requirements ↔ templatesTemplates and requirements.json exist
run_compliance_check()Verify GxP complianceRequirements and test results
Data Flow Semantics
FlowSemantic Meaning
VP → URSBusiness process analysis defines GxP scope for requirements
URS → FSFunctional requirements trace to design specifications
URS → RARequirement priority determines risk severity
RA → TestRisk level scales testing rigor (IQ/OQ/PQ scope)
All → RTMComplete traceability matrix for regulatory audit

Prompt Library

Critical Thinking Constraints and Content Fill Prompts are defined in prompts.md.

For GAMP 5 M12 Critical Thinking constraints, document generation triggering conditions, and content fill prompt templates, see prompts.md.

Reference Documents

Reference materials included in references/ folder:

FileDescription
gamp-5.mdGAMP 5 quick reference guide
21cfr-part11.md21 CFR Part 11 key requirements
annex-11.mdEU Annex 11 requirements
data-integrity.mdALCOA+ data integrity principles

Example Templates

Complete fill examples are provided in templates/examples/ directory:

Example FileDescription
urs-example.mdURS with complete requirement examples
fs-example.mdFS with traceability examples
ra-example.mdRA with hierarchical risk examples
iq-example.mdIQ with qualification check examples

AI agents SHOULD reference these examples for content style guidance when filling templates.

Bilingual Format

All templates support Smart Bilingual output controlled by --bilingual and --language flags:

--bilingual--languageBehavior
true (default)zhHeaders bilingual, content in Chinese
true (default)enHeaders bilingual, content in English
falsezhPure Chinese output
falseenPure English output
Bilingual Template Format

Templates use dual-language format for headers:

markdown
## 1. 目的 / Purpose

本文档定义了... / This document defines...

Tables use dual-language headers:

中文English
验证计划Validation Plan
用户需求User Requirements

Content cells use format like 中文 / English:

模块 / Module描述 / Description
用户管理 / User Management系统应... / System should...

Requirements Traceability

This skill supports GAMP 5 compliant requirements traceability across the entire validation lifecycle.

Automated Traceability Chain
代码注释 (@URS[module]) 
    ↓
requirements.json (需求解析)
    ↓
URS 模板 (自动同步章节)
    ↓
FS/TS 文档 (引用需求ID)
    ↓
测试用例 (关联需求ID)
    ↓
测试结果 (解析需求ID)
    ↓
RTM (追溯矩阵自动生成)
Code Comment Standards (AI Agent Must Follow)

When generating code, AI agents MUST include requirement markers for automatic traceability. Use the standardized @REQ format:

python
# @REQ URS-001 - 系统应支持基于角色的访问控制 (RBAC)
# @REQ URS-002 - 用户密码必须满足复杂度要求(至少8位)
# @FS FS-001
# @TS TS-001
# @TEST[OQ-UM-001] - 验证用户角色分配功能
# @RISK H  # High risk module

def assign_role(user_id: str, role: str) -> bool:
    '''
    @REQ URS-001 - Role-based access control required
    @TEST[OQ-UM-001] - Test role assignment
    '''
    # Implementation...

Standard comment formats:

PatternExampleDescription
// @REQ URS-xxx// @REQ URS-001 - 系统应支持RBACRequirement with ID and description
# @REQ# @REQ URS-001 - 描述Python-style comment
/* @REQ *//* @REQ URS-001 - 描述 */Multi-line comment
// @TEST[type-id]// @TEST[OQ-UM-001] - 验证Test case link
// @FS// @FS FS-001FS reference
// @TS// @TS TS-001TS reference
// @RISK [H/M/L]// @RISK HRisk level (High/Medium/Low)

Risk levels:

  • H (High): Security, compliance, electronic signature, audit trail related
  • M (Medium): Default for most requirements
  • L (Low): Simple features, documentation, reports
Show full SKILL.md (703 more words)Show less
Standard Modules
Module ID中文名English NameTest Prefix
user_mgmt用户管理User ManagementUM
audit_trail审计追踪Audit TrailAT
data_mgmt数据管理Data ManagementDM
business_func业务功能Business FunctionsBF
reporting报告功能ReportingRP
integration接口集成IntegrationINT
security安全SecuritySEC
compliance合规ComplianceCMP

注意: 章节号(4.X)是动态分配的,基于模板中已有的章节。同步时会自动为新模块分配下一个可用编号。

System Prompt Integration (Manual Configuration Required)

⛔ This step is NOT automatic. You must manually add these rules to your agent's system prompt (AGENTS.md) if you want @REQ/@TEST annotations to apply across ALL skills.

To enable cross-skill annotation enforcement, add the following to your AGENTS.md or agent system prompt:

Code Annotation Rules (for GxP traceability):
- When writing code that implements requirements, add @REQ markers: # @REQ URS-xxx - description
- When writing test cases, add @TEST markers: # @TEST[OQ-UM-xxx] - description
- Mark high-risk code sections with @RISK H (security, compliance, audit trail related)
- Mark medium-risk code with @RISK M
- Mark low-risk code with @RISK L

Why this is needed: OpenClaw skills only execute when active. There is no mechanism to make instructions persist across skill switches except via the system prompt.

See STANDARDS.md for full documentation and standards/code-annotations.json for the standards file.

Test Case ID Format

Test case IDs follow the format: {IQ|OQ|PQ}-{ModulePrefix}-{Number}

TypeExampleDescription
IQIQ-UM-001Installation Qualification test
OQOQ-UM-001Operational Qualification test
PQPQ-UM-001Performance Qualification test
Auto-Sync Feature

Before generating documents, use --sync to automatically update templates with new requirements:

bash
# Generate URS and sync requirements to template
python3 scripts/generate.py urs --sync \
  --project "临床系统" \
  --system "EDC v1.0" \
  --category 4 \
  --output ./validation/

# Generate full validation package with sync
python3 scripts/generate.py all --sync \
  --project "XX系统" \
  --system "MES" \
  --category 4 \
  --output ./validation/

What --sync does:

  1. Reads requirements.json for all requirements
  2. Groups requirements by module
  3. Checks if each module section exists in template
  4. Auto-appends new module sections if missing
  5. Backs up original template before modification
Sync Template to Database

Use --sync-template-to-db to extract requirements from templates and add them to requirements.json:

bash
# Extract requirements from urs.md template to requirements.json
python3 scripts/generate.py urs --sync-template-to-db \
  --project "临床系统" \
  --system "EDC v1.0" \
  --category 4 \
  --output ./validation/

What --sync-template-to-db does:

  1. Reads the template (e.g., urs.md)
  2. Extracts all requirements in | URS-xxx | description | format
  3. Loads existing requirements.json (if exists)
  4. Adds new requirements that don't already exist
  5. Preserves existing requirements and test results
Interactive Mode

For interactive step-by-step document generation with confirmation prompts:

bash
python3 scripts/generate.py all --interactive \
  --project "临床系统" \
  --system "EDC v1.0" \
  --category 4 \
  --output ./validation/

Interactive workflow:

[1/11] 解析代码注释...
  → 按 Enter 继续,'s' 跳过,'q' 退出:

[2/11] 同步需求到数据库...
  → 按 Enter 继续,'s' 跳过,'q' 退出:

[3/11] 生成 URS...
  → 按 Enter 继续,'s' 跳过,'q' 退出:
  ✓ ./output/URS_临床系统.docx
...

Options:

  • Enter - Execute this step
  • s - Skip this step
  • q - Quit (already generated files are preserved)
Compliance Check

Run GAMP 5 compliance validation to check requirements coverage and test coverage:

bash
# Run compliance check (text output)
python3 scripts/generate.py check \
  --requirements requirements.json \
  --test-results test_results.json

# Run compliance check (JSON output for CI/CD)
python3 scripts/generate.py check \
  --requirements requirements.json \
  --test-results test_results.json \
  --output-format json

Compliance checks performed:

  • Requirement coverage (ensures all code requirements are documented)
  • High-risk module verification (IQ/OQ/PQ tests for critical modules)
  • Test coverage threshold (default 80%)

Exit codes:

  • 0 - All checks passed
  • 1 - Warnings present
  • 2 - Errors found
Incremental Update (Smart Rebuild)

Use --diff-only to skip regeneration when requirements haven't changed:

bash
# Only regenerate RTM if requirements changed
python3 scripts/generate.py rtm --diff-only \
  --project "临床系统" \
  --system "EDC v1.0" \
  --category 4 \
  --output ./validation/

How it works:

  1. Computes SHA256 hash of requirements after each generation
  2. Stores hash in .requirements.hash in output directory
  3. On subsequent runs, compares current hash against stored hash
  4. Skips generation if hash matches (requirements unchanged)
Git Hooks (Automated Compliance)

Install post-commit hooks to automatically run compliance checks after code commits:

bash
# Install hooks locally (per-project)
./scripts/git-hooks/install.sh --local

# Install hooks globally (all projects)
./scripts/git-hooks/install.sh --global

# Uninstall hooks
./scripts/git-hooks/install.sh --uninstall

What the hook does:

  • Detects commits with code or requirements changes
  • Runs compliance check (non-blocking)
  • Outputs warnings to stderr without blocking commit
Bidirectional Sync

Use --sync for bidirectional sync between template and requirements.json:

bash
# Full bidirectional sync (both directions)
python3 scripts/generate.py urs --sync \
  --project "临床系统" \
  --system "EDC v1.0" \
  --category 4

# Only sync template → JSON
python3 scripts/generate.py urs --sync --sync-direction to-json

# Only sync JSON → template
python3 scripts/generate.py urs --sync --sync-direction to-template

Conflict resolution:

bash
# Keep template descriptions on conflict
python3 scripts/generate.py urs --sync --conflict-resolution template

# Keep JSON descriptions on conflict
python3 scripts/generate.py urs --sync --conflict-resolution json

# Keep newer version based on updated_at
python3 scripts/generate.py urs --sync --conflict-resolution newer

Section numbering behavior:

  • Sync automatically creates module sections with ### 4.X headers
  • Section numbers are dynamically assigned based on existing sections in the template
  • Only modules with requirements in requirements.json will have sections created
  • Custom modules (e.g., pm_query, multi_lock) are supported and will be assigned the next available section number
Monorepo Support

For projects with multiple subprojects (monorepo structure):

bash
# Auto-detect monorepo root
python3 scripts/generate.py rtm --project "临床系统" --system "EDC v1.0"

# Explicitly specify monorepo root
python3 scripts/generate.py rtm --project "临床系统" --system "EDC v1.0" \
  --project-root /path/to/monorepo

Detected monorepo layouts:

  • apps/, packages/, projects/, modules/, services/ directories
  • Each subproject with its own requirements.json
Template Versioning

Templates are versioned for compatibility tracking:

bash
# Check compatibility (automatic on generate)
python3 scripts/generate.py rtm --project "系统" --system "v1.0" --category 4

# Specify template version
python3 scripts/generate.py rtm --template-version 1.2.0 \
  --project "系统" --system "v1.0" --category 4

Automatic migrations:

  • Templates are automatically migrated to current version
  • Version checks prevent incompatible generator/template combinations
CI/CD Integration

Use provided CI/CD templates for automated documentation generation:

GitHub Actions (templates/ci/github-actions.yml):

yaml
- uses: actions/checkout@v4
- uses: actions/setup-python@v5
  with:
    python-version: '3.11'
- run: pip install -r requirements.txt
- run: python scripts/generate.py check --output-format json
- run: python scripts/generate.py all --diff-only

GitLab CI (templates/ci/gitlab-ci.yml):

yaml
generate:rtm:
  extends: .csv-docs-base
  script:
    - python scripts/generate.py rtm --diff-only
  artifacts:
    paths:
      - validation/RTM*.xlsx
Important Notes
Template Requirements Are Examples

The URS/FS/TS IDs and descriptions in templates are examples only. For actual projects:

  1. Review and modify template requirements based on real system needs
  2. Delete or replace example requirements as appropriate
  3. Use --sync-template-to-db to populate initial requirements, then customize
Change-Driven Risk Assessment (GxP)

Per GxP requirements, any system change requires a risk assessment. When generating RA documents, include the change description:

bash
python3 scripts/generate.py ra \
  --project "临床系统" \
  --system "EDC v1.0" \
  --change-description "升级数据库从 v12 到 v14" \
  --output ./validation/
Parsing Requirements from Code
bash
# Navigate to skill directory
cd <SKILL_DIR>/csv-documentation-generator

# Parse source code for requirements using csv-docs CLI
python3 scripts/cli.py parse ./src

# View extracted requirements
cat requirements.json

Troubleshooting

Common Issues
IssueSolution
python-docx not installedRun: pip install -r requirements.txt
Encoding errorsEnsure UTF-8 encoding in your terminal
Template not foundCheck you are in the correct directory
Getting Help

Run with verbose output:

bash
python3 scripts/generate.py --help

Examples

AI Agent (Non-Interactive Mode)

For AI agents running in non-interactive mode, use --auto-add to automatically add all parsed requirements:

bash
# Parse and auto-add all requirements (non-interactive)
python3 scripts/cli.py parse ./src --auto-add

# Generate with verbose output
python3 scripts/generate.py all --project "XX系统" --system "System v1.0" --category 4 --verbose
Example 1: Generate URS for CTMS
bash
python3 scripts/generate.py urs \
  --project "临床试验管理系统" \
  --system "CTMS v2.0" \
  --category 4 \
  --bilingual true \
  --output ./validation/
Example 2: Generate Risk Assessment
bash
python3 scripts/generate.py ra \
  --project "质量管理系统" \
  --system "QMS v1.5" \
  --category 4 \
  --critical-functions "数据录入,审计追踪,权限控制" \
  --output ./validation/
Example 3: Generate Traceability Matrix
bash
python3 scripts/generate.py rtm \
  --project "实验室系统" \
  --system "LIMS v3.0" \
  --category 4 \
  --urs-file ./URS-001.md \
  --fs-file ./FS-001.md \
  --output ./validation/

© LeoYeAI, MIT. Rendered from Markdown: HTML in the file is shown as text, images as links, and headings moved down two levels. Raw file

Files

SKILL.md and 67 other files (scripts, references) in skills/csv-documentation-generator of LeoYeAI/openclaw-master-skills.

  • SKILL.md
  • .csv-docs-config.json
  • CHANGELOG.md
  • CHANGELOG_en.md
  • README.md
  • README_en.md
  • STANDARDS.md
  • _meta.json
  • audit-log.json
  • prompts.md
  • references/21cfr-part11.md
  • references/annex-11.md
  • references/data-integrity.md
  • references/gamp-5.md
  • requirements.json
  • requirements.txt
  • scripts/__init__.py
  • scripts/agent.py
  • scripts/audit
  • … and 49 more

Open the folder on GitHubat commit e5199b5

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CSV Documentation Generator next to the 5 skills that share the most tags, products or categories with it. Stars are the repository's; “used in” counts other GitHub owners with a copy.

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Abuse Hunternexu-io/harness-engineering-guide663—~1.9kAutomated safety check: PassMIT
Markitshift-labs-ai/markit1.3k—~299Automated safety check: PassMIT
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Questions about CSV Documentation Generator

What does CSV Documentation Generator do?

A skill your agent uses when generating computer system validation (CSV) documentation for pharmaceutical and medical device industries, including validation plans, URS, FS, IQ/OQ/PQ documents, and…. CSV Documentation Generator is an agent skill from LeoYeAI/openclaw-master-skills. 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.

When should I use CSV Documentation Generator?

CSV Documentation Generator fits situations like: generating computer system validation (CSV) documentation for pharmaceutical and medical device industries; including validation plans; IQ/OQ/PQ documents; traceability matrices.

How do I install CSV Documentation Generator in Claude Code?

Run `npx skills add LeoYeAI/openclaw-master-skills --skill csv-documentation-generator -a claude-code`. Or copy the skill folder (skills/csv-documentation-generator in LeoYeAI/openclaw-master-skills) into .claude/skills/csv-documentation-generator in your project. Claude Code loads it when a task matches its description.

How do I install CSV Documentation Generator in Codex?

Run `npx skills add LeoYeAI/openclaw-master-skills --skill csv-documentation-generator -a codex`. Or copy the skill folder (skills/csv-documentation-generator in LeoYeAI/openclaw-master-skills) into .agents/skills/csv-documentation-generator in your project. Codex loads it when a task matches its description.

Can I use CSV Documentation Generator in Cursor, Gemini CLI or GitHub Copilot?

Cursor, Gemini CLI, GitHub Copilot and OpenCode also load SKILL.md folders. With the skills CLI, run `npx skills add LeoYeAI/openclaw-master-skills --skill csv-documentation-generator -a cursor` (or -a gemini-cli, github-copilot or opencode for the others). To copy it by hand, put the folder in .cursor/skills/csv-documentation-generator, .gemini/skills/csv-documentation-generator, .github/skills/csv-documentation-generator and .opencode/skills/csv-documentation-generator in your project.

What does CSV Documentation Generator need to run?

Going by SKILL.md and its folder, CSV Documentation Generator needs Python for the scripts in its folder and the command-line tools its instructions call (python3 and pip). Our summary lists: Python 3. Compatibility (from SKILL.md): {"openclaw":">=1.0.0","python":">=3.10"}.

Does CSV Documentation Generator access the network?

SKILL.md contains no URLs. Its commands use pip, which can reach the network depending on how they are called. This is read from the text; nothing was executed.

Is CSV Documentation Generator safe to install?

Our automated static check of SKILL.md found no risky patterns, such as piping downloads into a shell, reading credential files or hidden Unicode. It is not a guarantee. The check reads SKILL.md only: the scripts in the folder are not scanned, so read them before running anything.

What licence does CSV Documentation Generator use?

CSV Documentation Generator is published under the MIT licence (the repository's licence). It allows redistribution, so the full SKILL.md is shown on this page.

How many tokens does CSV Documentation Generator use?

About 6.6k tokens (SKILL.md is roughly 26k characters). Agents keep only the skill's name and description in context until a task matches; then they load SKILL.md in full. Its references folder adds about 3.5k tokens, read only when the agent opens those files.

What are the alternatives to CSV Documentation Generator?

Skills that share tags, products or a category with CSV Documentation Generator: Data Table Manager (n8n-io/n8n, 207k stars), Instrument Data To Allotrope (aws-samples/amazon-bedrock-agents-healthcare-lifesciences, 274 stars), Abuse Hunter (nexu-io/harness-engineering-guide, 663 stars) and Markit (shift-labs-ai/markit, 1.3k stars). The comparison table on this page puts their stars, adoption, token cost, safety result and licence side by side.

Who maintains CSV Documentation Generator?

LeoYeAI (a GitHub user) maintains it in LeoYeAI/openclaw-master-skills, which has 2,159 GitHub stars. The repository holds 972 skills in this directory. The repository was last updated on July 20, 2026.

Source: LeoYeAI/openclaw-master-skills on GitHub. Facts on this page come from the repository at the commit we read; the author's words are quoted as theirs.