| name | design-compliance-architecture-pjt222 |
| title | 設合規架構 |
| description | Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inventory, criticality classification (GxP-critical, GxP-supporting, non-GxP), GAMP 5 category assignment, regulatory requirements traceability, and governance structure definition. Use when establishing a new regulated facility, formalising compliance across multiple systems, addressing a regulatory gap analysis, harmonising compliance after mergers or reorganisations, or preparing a site master file that references computerized systems. |
| author | pjt222 |
| author_url | https://github.com/pjt222/agent-almanac/tree/main/i18n/wenyan/skills/design-compliance-architecture |
| license | MIT |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | general |
| practice | life-sciences |
| language | zh |
設合規架構
立頂層合規框，映法規至系統、分要度、定受管境之治理。
用時
- 新受管之設施、部門或項目立
- 既有組織需跨諸系正其合規態
- 合規差析揭系統分類或驗策之缺
- 併購或重組需跨實體統合規
- 備場主文件或質手冊引諸計算系統
入
- 必要：在範計算系統之單（名、用、供/自造）
- 必要：適法規框（21 CFR Part 11、EU Annex 11、GMP、GLP、GCP、ICH Q7、ICH Q10）
- 必要：組境（部、場、品類）
- 可選：既有之驗主計或質手冊
- 可選：前審發或法規察
- 可選：附質與 IT 報告線之組圖
法
第一步：建系統清冊
建全面之計算系統清冊：
# System Inventory
## Document ID: SI-[SITE]-[YYYY]-[NNN]
| ID | System Name | Version | Vendor | Purpose | Department | Data Types | Users |
|----|-------------|---------|--------|---------|------------|------------|-------|
| SYS-001 | LabWare LIMS | 8.1 | LabWare Inc. | Sample management and testing | QC | Test results, COA | 45 |
| SYS-002 | SAP ERP | S/4HANA | SAP SE | Batch release and inventory | Production | Batch records, BOM | 120 |
| SYS-003 | Custom R/Shiny | 2.1.0 | Internal | Statistical analysis | Biostatistics | Clinical data | 8 |
| SYS-004 | Windows Server | 2022 | Microsoft | File server | IT | Documents | 200 |
得： 建、改、存、取、傳 GxP 相關數據之諸系統皆列。
敗則： 若系統主不能供全資，錄缺而排發現會。缺系統為關鍵合規險。
第二步：分系統要度
各系統賦要度層：
# System Criticality Classification
## Document ID: SCC-[SITE]-[YYYY]-[NNN]
### Classification Criteria
| Tier | Definition | Validation Required | Examples |
|------|-----------|-------------------|----------|
| **GxP-Critical** | Directly impacts product quality, patient safety, or data integrity. Generates or processes GxP records. | Full CSV per GAMP 5 | LIMS, ERP (batch), CDMS, MES |
| **GxP-Supporting** | Supports GxP processes but does not directly generate GxP records. Failure has indirect impact. | Risk-based qualification | Email, document management, scheduling |
| **Non-GxP** | No impact on product quality, safety, or data integrity. | IT standard controls only | HR systems, cafeteria, general web |
### System Classification Matrix
| System ID | System | Tier | Rationale |
|-----------|--------|------|-----------|
| SYS-001 | LabWare LIMS | GxP-Critical | Generates test results used for batch release |
| SYS-002 | SAP ERP | GxP-Critical | Manages batch records and material traceability |
| SYS-003 | R/Shiny App | GxP-Critical | Performs statistical analysis for regulatory submissions |
| SYS-004 | Windows Server | GxP-Supporting | Stores controlled documents but does not generate GxP data |
