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发表于 2018-4-30 18:51:09
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个人意见：
记录除了“记录”的作用外，还有相应的“指导”作用；
如果在批记录中不体现“几点到几点在什么工序”并没有实质性的风险的话（比如不起到及时指导作用），建议不设计进入纸质记录，可以采用辅助记录附在主批记录中呈现（以其他形式（打印，誊写）），并进行签字复核。实际操作中对于汇总数据等都事后进行的。
如果必须体现在主批记录中，或者不填写的话风险相对较高，那么就不存在事后补写的条件了，这种情况下是需要及时填写的（即使是誊写电子数据，也必须及时）。
至于ALCOA原则的适用对象：
Medicines regulatory systems worldwide have always depended upon theknowledge of organizations that develop, manufacture and package, test,distribute and monitor pharmaceutical products. Implicit in the assessmentand review process is trust between the regulator and the regulated thatthe information submitted in dossiers and used in day-to-day decisionmakingis comprehensive, complete and reliable. The data on whichthese decisions are based should therefore be complete as well as beingattributable, legible, contemporaneous, original and accurate, commonlyreferred to as “ALCOA”.
data定义
Data means all original records and true copies of original records,including source data and metadata and all subsequent transformations andreports of these data, which are generated or recorded at the time of the GXPactivity and allow full and complete reconstruction and evaluation of the GXPactivity. Data should be accurately recorded by permanent means at the timeof the activity. Data may be contained in paper records (such as worksheetsand logbooks), electronic records and audit trails, photographs, microfilmor microfiche, audio- or video-files or any other media whereby informationrelated to GXP activities is recorded.
选自：Guidance on good data and record management practices
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