# Life Sciences & Pharma — General (jurisdiction-agnostic)

Cross-agency life-sciences quality and compliance — GxP audits, compliance-architecture and computerised-system validation (IQ/OQ/PQ), data integrity (ALCOA+), inspection readiness (FDA/EMA/MHRA), vendor qualification, and EU MDR device compliance.

Jurisdiction: `general` · Practice: `life-sciences` · Skill language varies per skill (see each `SKILL.md`).

## Skills (11)

| Skill | What it does |
|---|---|
| [`Conduct GxP Audit`](skills/conduct-gxp-audit/) | Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence c… |
| [`行 GxP 稽核`](skills/conduct-gxp-audit-2/) | Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence c… |
| [`Conduct GxP Audit`](skills/conduct-gxp-audit-pjt222/) | Conduct a GxP audit of computerized systems and processes. Covers audit planning, opening meetings, evidence c… |
| [`Design Compliance Architecture`](skills/design-compliance-architecture/) | Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inven… |
| [`設合規架構`](skills/design-compliance-architecture-pjt222/) | Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inven… |
| [`監測資料完整性`](skills/monitor-data-integrity/) | Design and operate a data integrity monitoring programme based on ALCOA+ principles. Covers detective controls… |
| [`Prepare Inspection Readiness`](skills/prepare-inspection-readiness/) | Prepare an organisation for regulatory inspection by assessing readiness against agency-specific focus areas (… |
| [`備檢查就緒`](skills/prepare-inspection-readiness-2/) | 備組織受監管檢查：對機構特定焦點區（FDA, EMA, MHRA）評備度。含警告信 與 483 主題析、模擬檢查協、文件包備、檢查事務、應對模板。 監管檢查已宣或預期、定期自評、上檢後已施新系、或重大審計發現或致監管注時… |
| [`備檢準備度`](skills/prepare-inspection-readiness-pjt222/) | Prepare an organisation for regulatory inspection by assessing readiness against agency-specific focus areas (… |
| [`資廠商`](skills/qualify-vendor/) | 資 GxP 相關軟體或服務之廠商或供。含廠險分、評問卷設、案頭與現場審法、 質協評、SLA 審、續監節奏定。 GxP 關鍵系統擇新廠、為合規數納雲供、行定期重資、審發現需重評、 或 EU Annex 11 或 ICH Q… |
| [`書驗文`](skills/write-validation-documentation/) | Write IQ/OQ/PQ validation documentation for computerized systems in regulated environments. Covers protocols,… |
