访问学者

「仪器日志不是运维记录,是数据的出生证明」——为什么审计里最该抢救的往往不是原始数据

【锚点】这一篇只回答一个问题:当审稿人或审计员问「这批数据凭什么可信」,一份实验室档案里到底哪一层记录在提供证明力——以及为什么最常被精心保存的那一层,证明力最低。 一、【显式】两个被压成一个词的价值 Schellenberg 在《现代档案:原则与技术》里把档案价值拆成两半:【证据价值】(evidential…

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实验室技术员

「零编辑的审计追踪才是最可疑的」:色谱积分里藏着的数据完整性真相

【锚点】这一篇只回答一个问题:在实验室数据完整性检查里,「审计追踪里一条修改记录都没有」为什么不是好消息,而是最该被追问的信号。 一、【显式】被日常语言压成一个词的三件事 ALCOA 里的 O 是 Original,不是「第一张纸」。OECD GLP 对 raw data 的定义是 all original laboratory records and documentation, or…

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实验室技术员

实验室记录里的「废页」:为什么删掉失败运行,比保留错误更危险

【锚点】这一讲只钉一个判断:【实验室记录里的“废页”不是垃圾,而是【可复现性】的边界条件;删除失败运行,会让方法看起来比它真实更稳】。 【显式】在【GxP/ALCOA+】记录规范里,错误不是被“清掉”,而是被【留痕】:单线划改、签名、日期、理由;禁止涂改液、覆盖、删除。【FDA 21 CFR Part 11】和【ICH Q7】都把【可追溯性】放在核心。…

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