Based on the outcome of gap analysis and compliance assessment, our consult(s) could assist client with document improvement to meet the requirements including but not limited to following documents:
根据差异分析及合规性评估的结果, 辅导客户进行文件修订，以达到合规目的，主要文件目录包括但不限于以下：
Organization and Personnel 组织及人员
- Training Management培训管理
- Personnel and Responsibilities人员及职责
Facility, Utilities and Equipment plant 厂房，设施 及设备
- User requirements 用户需求
- Design verification设计确定
- Equipment calibration 设备校准
- Preventative maintenance预防保养
- Computerized system management电子计算机化系统管理
Material and Storage 物料及贮存
- Supplier management供应商管理
- Warehouse management仓库管理
- Temperature and humidity mapping 温度湿度分布
Process Control 工艺控制
- Production batch records 生产批记录
- Critical process parameters 关键工艺参数
- Prevention of cross-contamination 交叉污染预防
- Lot definition 批定义
Verification and Validation 确认及验证
- Master validation plan 验证主计划
- Protocol & report 方案及报告
Contract Services (CRO, CMO, etc.) 委托服务
- Contract agreement 委托合同协议
- Contract audit 委托审计
Quality Assurance 质量保证
- Quality management system质量管理系统
- Quality policy质量方针
- Guidance /SOPs / Records指导/标准操作程序/记录
- Deviation偏差管理
- CAPA纠正与预防
- Change control 变更管理
- Document control 文件管理
- Risk management 风险评估
- Custom complaint客户投诉
- Annual review 年度回顾
Quality Control 质量控制
- Quality standard and testing records 质量标准及测试记录
- Sample management 样品管理
- Reagent management 试剂管理
- Sampling plan 取样计划
- Sample retains 样品留样
- Testing procedures测试方法
- Method qualification and transfer方法确证及转移
- OOS and OOT超标及超趋向
- Raw material and product release
- Stability assessment稳定性分析
- Reference standard management标准品/对照品管理
- Instrument & apparatus management仪器设备管理
- Preventative maintenance 预防性维护管理