医疗器械计算机软件验证方案模板
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目 录
1. 确认目的...........................................................................................................................5
2. 确认范围...........................................................................................................................5
3. 确认职责...........................................................................................................................5
4. 确认指导文件...................................................................................................................6
5. 术语缩写...........................................................................................................................6
6. 概述 ...................................................................................................................................6
7. 确认实施前提条件 ..........................................................................................................4
8. 人员确认...........................................................................................................................7
9. 风险评估...........................................................................................................................7
10. 确认时间安排................................................................................................................ 13
11. 确认内容........................................................................................................................ 13
12. 偏差处理........................................................................................................................ 31
13. 风险的接收与评审 .......................................................................................................32
14. 方案修改记录................................................................................................................ 32
15. 确认计划........................................................................................................................ 32
16. 附件 ..................................................................................................错误!未定义书签。
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