{"skill":{"slug":"gxp-compliance","displayName":"Gxp Compliance","summary":"GxP合规检查与供应商问卷分析Skill。当需要分析、评估、检查以下主题时触发： (1) GxP相关合规要求（GMP、GLP、GCP、GDP等） (2) 计算机化系统验证(CSV)流程与文档 (3) GAMP5第二版(2022)变更与合规 (4) FDA 21 CFR Part 11电子记录与电子签名 (5) 电...","tags":{"latest":"1.0.0"},"stats":{"comments":0,"downloads":67,"installsAllTime":0,"installsCurrent":0,"stars":0,"versions":1},"createdAt":1777022450827,"updatedAt":1777023707809},"latestVersion":{"version":"1.0.0","createdAt":1777022450827,"changelog":"Initial release of gxp-compliance skill for GxP compliance assessment and supplier questionnaire analysis.\n\n- Provides structured methods for GxP compliance checks (GMP, GLP, GCP, GDP, CSV, GAMP5, 21 CFR Part 11, data integrity, etc.).\n- Includes templates for supplier questionnaire analysis, risk scoring, and compliance gap reports.\n- Supplies ready-to-use checklists, evaluation matrices, and reporting formats (Markdown).\n- Lays out key assessment criteria, risk definitions, and supplier approval standards.\n- Offers practical examples for supplier evaluation, Part 11 compliance, and GAMP5 categorization.","license":"MIT-0"},"metadata":null,"owner":{"handle":"zealot00","userId":"s17b205tnyke99436yfdvpafkx83hrjt","displayName":"zealot","image":"https://avatars.githubusercontent.com/u/5056784?v=4"},"moderation":null}