目 录1． 确认目的 ························································22． 确认范围 ························································23． 方案阐明 ························································24． 验证职责 ························································25． 仪器概述 ························································26． 确认环节 ·······················································27． 偏差处理 ·······················································78． 风险评估 ·······················································79． 确认总结 ·······················································710．再验证周期·······················································811．验证证书 ·······················································9一、确认目的此验证是为确认气相色谱仪的运行和多种性能指标与否满足规定规定。二、确认范围证明并保证本仪器确认后，经本仪器检查的数据真实可靠。三、方案阐明1.尽量详细地填写本方案中的所有表格。用墨水笔填写。完毕表格的人员应签上姓名和日期。假如由一种以上的人填写，那么每一种人都应签上姓名和日期。2.方案执行时也许会发现偏差。一旦这种状况发生，应将一份“异常状况汇报”送交验证领导小组进行处理。3． 验证小组最终做出验证汇报，该汇报由企业验证负责人同意。四、验证职责 1．验证领导小组负责验证工作的组织和协调。负责验证数据及成果的审批。负责验证汇报的审批。 2. 质量部 负责验证的检查工作。负责保管验证文献。...
