1 回答
Yes. Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original record, which includes all metadata required to reconstruct the CGMP activity and the static or dynamic nature of the original records.
可以。电子拷贝可以作为纸质或电子记录的真实副本,前提是该拷贝中保存了原始记录的内容和内涵,其中应包括重现CGMP活动所需的所有元数据以及原始记录的静态或动态属性。
True copies of dynamic electronic records may be made and maintained in the format of the original records or in a format that allows for the content and meaning of the original records to be preserved if a suitable reader and copying equipment (e.g., software and hardware, including media readers) are readily available (§§ 211.180(d) and 212.110).
动态电子记录的真实拷贝件可以以原始记录的格式来创建和保存,或者,若有配备适当的阅读器和拷贝设备时(例如软件、硬件,包括媒体阅读器)(§211.180(d)和212.110),以允许原始记录的内容和含义均得以保存的格式来创建和保存。