write-validation-documentation

name	write-validation-documentation
title	書驗文
description	Write IQ/OQ/PQ validation documentation for computerized systems in regulated environments. Covers protocols, reports, test scripts, deviation handling, and approval workflows. Use when validating R or other software for regulated use, preparing for a regulatory audit, documenting qualification of computing environments, or creating and updating validation protocols and reports for new or re-qualified systems.
author	pjt222
author_url	https://github.com/pjt222/agent-almanac/tree/main/i18n/wenyan-ultra/skills/write-validation-documentation
license	MIT
version	0.1.0
execution_mode	open
jurisdiction	general
practice	life-sciences
language	zh

書驗文

立計算系之全 IQ/OQ/PQ 驗文。

用

• 為管用驗 R 或他軟→用
• 備管審→用
• 錄計境之資→用
• 新或重資系建更驗綱與報→用

入

• 必：欲驗系/軟（名、版、用）
• 必：定範與策之驗計
• 必：用要規
• 可：現 SOP 模
• 可：前驗文（重資）

行

一：書 IQ 綱

# Installation Qualification Protocol
**System**: R Statistical Computing Environment
**Version**: 4.5.0
**Document ID**: IQ-PROJ-001
**Prepared by**: [Name] | **Date**: [Date]
**Reviewed by**: [Name] | **Date**: [Date]
**Approved by**: [Name] | **Date**: [Date]

## 1. Objective
Verify that R and required packages are correctly installed per specifications.

## 2. Prerequisites
- [ ] Server/workstation meets hardware requirements
- [ ] Operating system qualified
- [ ] Network access available (for package downloads)

## 3. Test Cases

### IQ-001: R Installation
| Field | Value |
|-------|-------|
| Requirement | R version 4.5.0 correctly installed |
| Procedure | Open R console, execute `R.version.string` |
| Expected Result | "R version 4.5.0 (2025-04-11)" |
| Actual Result | ______________________ |
| Pass/Fail | [ ] |
| Executed by | ____________ Date: ________ |

### IQ-002: Package Inventory
| Package | Required Version | Installed Version | Pass/Fail |
|---------|-----------------|-------------------|-----------|
| dplyr | 1.1.4 | | [ ] |
| ggplot2 | 3.5.0 | | [ ] |
| survival | 3.7-0 | | [ ] |

## 4. Deviations
[Document any deviations from expected results and their resolution]


[ ] All IQ tests PASSED - system installation verified
[ ] IQ tests FAILED - see deviation section