关于设备使用记录的回溯性填写问题

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6.2 Equipment Cleaning and Use Record
6.20 Records of major equipment use, cleaning, sanitization and/or sterilization and maintenance should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment, and the person who performed the cleaning and maintenance.
——选自ICH Q7A
针对于设备的使用记录，完全可以采取回溯性的填写方式，而不需要按照contemporaneously recorded的原则吧，只要能够根据批记录的数据源进行重构，大家怎么认为？？？（包括一些称量设备的使用记录）

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6.2 Equipment Cleaning and Use Record
6.20 Records of major equipment use, cleaning, sanitization and/or sterilization and maintenance should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment, and the person who performed the cleaning and maintenance.
6.21 If equipment is dedicated to manufacturing one intermediate or API, then individual equipment records are not necessary if batches of the intermediate or API follow in traceable sequence. In cases where dedicated equipment is employed, the records of cleaning, maintenance, and use can be part of the batch record or maintained separately.
针对于非专用设备线，建议将设备使用，清洁和维护记录（至少是log）在一张表单进行体现，以做到整体性，而针对于专用设备线，则可以将设备使用，清洁和维护记录（至少log）分开进行记录和维护。

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FDA’s Draft Guidance on Data Integrity: The Cupola on a Tower of Guidances