| 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
