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 | | SCADA/DCS | Category 2/3 | VP, URS, IQ, OQ, PQ | | Custom Software | Category 3/4 | VP, URS, RA, IQ, OQ |

Quick Start

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Parse Requirements from Code (pre-generation)

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Auto Environment Setup

This skill automatically handles environment setup:

1. 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:

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

Available Commands

Command	Description	Output Format
INLINECODE2	Validation Plan	.docx
INLINECODE3

User Requirements Specification | .docx | | generate.py fs | Functional Specification | .docx | | generate.py ts | Technical Specification | .docx | | generate.py ra | Risk Assessment (FMEA) | .docx | | generate.py iq | Installation Qualification | .docx | | generate.py oq | Operational Qualification | .docx | | generate.py pq | Performance Qualification | .docx | | generate.py rtm | Traceability Matrix | .xlsx | | generate.py vsr | Validation Summary Report | .docx | | generate.py checklist | Validation Checklist | .xlsx | | generate.py test-case | Test Case Template | .xlsx | | generate.py all | Full validation package | .docx / .xlsx |

Command Options

Option	Description	Required
INLINECODE15	Project name	Yes
INLINECODE16

System name and version | Yes | | --category | GAMP category (1-5). If not specified, interactive selection will be prompted with bilingual GAMP 5 guidance. | No (will prompt) | | --bilingual | Enable bilingual mode: 'true' or 'false' (default: true). When true, headers remain bilingual and content follows --language. | No | | --language | Primary language for content: 'zh' (Chinese) or 'en' (English) (default: zh). Used when bilingual=false or for content in bilingual mode. | No | | --verbose / -v | Show detailed progress information (default: simplified output) | No | | --output | Output directory | Yes | | --format | Output format: docx, xlsx, or both (default: both) | No |

Output Format Standards

All generated documents follow consistent naming and formatting rules:

Document Naming Convention

Document Type	Format	Example
Validation Plan	INLINECODE24	VPXX系统.docx
User Requirements

{TYPE}_{PROJECT}.{ext} | URSXX系统.docx | | Functional Specification | {TYPE}_{PROJECT}.{ext} | FS_XX系统.docx | | Traceability Matrix | RTM_{PROJECT}.{ext} | RTM_XX系统.xlsx |

Output Directory Structure

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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:

Variable	Description	Example
INLINECODE28	Project name	临床试验系统
INLINECODE29

System name | EDC v1.0 |
| {SYSTEM_VERSION} | System version | 1.0 |
| {GAMP_CATEGORY} | GAMP category | 4 |
| {DOC_ID} | Document ID | URS-001 |
| {DATE} | Document date | 2024-01-01 |
| {AUTHOR} | Document author | 张三 |
| {REVIEWER} | Reviewer name | 李四 |
| {APPROVER} | Approver name | 王五 |

Regulatory Compliance

GAMP 5 Categories

Category	Description	Validation Approach
1	Operating System	Legacy
2

Firmware | Simplified | | 3 | Commercial-off-the-shelf (COTS) | Risk-based | | 4 | Configured COTS | Risk-based | | 5 | Custom/Critical | Full 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

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Semantic Actions

Action	Description	Pre-conditions
INLINECODE37	Parse @URS, @FS, @TEST markers from source code	Source code available
INLINECODE38

Create Validation Plan | Project name, system name, GAMP category | | generate_urs() | Create User Requirements Specification | System context, GxP scope | | generate_fs() | Create Functional Specification | URS requirements linked | | generate_ra() | Create Risk Assessment | URS priorities, GxP scope | | generate_iq_oq_pq() | Create Qualification Protocols | RA risk levels, TS config | | generate_rtm() | Create Traceability Matrix | URS, FS, test cases linked | | generate_vsr() | Create Validation Summary Report | All test results, deviations | | sync_bidirectional() | Sync requirements ↔ templates | Templates and requirements.json exist | | run_compliance_check() | Verify GxP compliance | Requirements and test results |

Data Flow Semantics

Flow	Semantic Meaning
VP → URS	Business process analysis defines GxP scope for requirements
URS → FS

Functional requirements trace to design specifications | | URS → RA | Requirement priority determines risk severity | | RA → Test | Risk level scales testing rigor (IQ/OQ/PQ scope) | | All → RTM | Complete 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:

File	Description
INLINECODE50	GAMP 5 quick reference guide
INLINECODE51

21 CFR Part 11 key requirements |
| annex-11.md | EU Annex 11 requirements |
| data-integrity.md | ALCOA+ data integrity principles |

Example Templates

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

Example File	Description
INLINECODE55	URS with complete requirement examples
INLINECODE56

FS with traceability examples |
| ra-example.md | RA with hierarchical risk examples |
| iq-example.md | IQ 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:

INLINECODE61	INLINECODE62	Behavior
INLINECODE63 (default)	INLINECODE64	Headers bilingual, content in Chinese
INLINECODE65 (default)

en | Headers bilingual, content in English |
| false | zh | Pure Chinese output |
| false | en | Pure English output |

Bilingual Template Format

Templates use dual-language format for headers:

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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

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Code Comment Standards (AI Agent Must Follow)

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

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Standard comment formats:

Pattern	Example	Description
INLINECODE73	INLINECODE74	Requirement with ID and description
INLINECODE75

# @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-001 | FS reference |
| // @TS | // @TS TS-001 | TS reference |
| // @RISK [H/M/L] | // @RISK H | Risk level (High/Medium/Low) |

Risk levels:

• - H (High): Security, compliance, electronic signature, audit trail related
• INLINECODE88 (Medium): Default for most requirements
• INLINECODE89 (Low): Simple features, documentation, reports

Standard Modules

Module ID	中文名	English Name	Test Prefix
INLINECODE90	用户管理	User Management	UM
INLINECODE91

审计追踪 | Audit Trail | AT | | data_mgmt | 数据管理 | Data Management | DM | | business_func | 业务功能 | Business Functions | BF | | reporting | 报告功能 | Reporting | RP | | integration | 接口集成 | Integration | INT | | security | 安全 | Security | SEC | | compliance | 合规 | Compliance | CMP |

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:

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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}

Type	Example	Description
IQ	INLINECODE101	Installation Qualification test
OQ

OQ-UM-001 | Operational Qualification test |
| PQ | PQ-UM-001 | Performance Qualification test |

Auto-Sync Feature

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

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What --sync does:

1. 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:

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

1. 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:

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Interactive workflow:
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Options:

• - Enter - Execute this step
• INLINECODE112 - Skip this step
• INLINECODE113 - Quit (already generated files are preserved)

Compliance Check

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

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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
• INLINECODE115 - Warnings present
• INLINECODE116 - Errors found

Incremental Update (Smart Rebuild)

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

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How it works:

1. 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:

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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:

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Conflict resolution:
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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):

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Detected monorepo layouts:

• - apps/, packages/, projects/, modules/, services/ directories
• Each subproject with its own INLINECODE129

Template Versioning

Templates are versioned for compatibility tracking:

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

Template Requirements Are Examples

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

1. 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:

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Parsing Requirements from Code

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Troubleshooting

Common Issues

Issue	Solution
python-docx not installed	Run: INLINECODE133
Encoding errors

Ensure UTF-8 encoding in your terminal | | Template not found | Check you are in the correct directory |

Getting Help

Run with verbose output:
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Examples

AI Agent (Non-Interactive Mode)

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

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Example 1: Generate URS for CTMS

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Example 2: Generate Risk Assessment

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Example 3: Generate Traceability Matrix

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