关于“backup”的理解？？？

beiwei5du

各位蒲友：


最近有看几大监管机构的关于“data integrity”的规定和指南，其中在FDA的2016年GFI data integrity and compliance wtih CGMP中第5个问题：
How does FDA use the term “backup” in § 211.68(b)?


FDA uses the term backup in § 211.68(b) to refer to a true copy of the original data that is maintained securely throughout the records retention period (for example, § 211.180). The backup file should contain the data (which includes associated metadata) and should be in the original format or in a format compatible with the original format.
This should not be confused with backup copies that may be created during normal computer use and temporarily maintained for disaster recovery (e.g., in case of a computer crash or other interruption). Such temporary backup copies would not satisfy the requirement in § 211.68(b) to maintain a backup file of data.



其中提到“backup”和“backup copy”的概念，而没有achival的概念，而在其他地区监管机构中有“backup”和“achival”的两个概念，同时没有backup copy的概念。按照上文提及的“backup”是否应该是其他监管机构指南中的archival的概念，而“backup copy”应该为其他指南中所说的“backup”？？？？

阿炳1987

没过大片里是“退后”

yc20160802

请提供achival概念的引文出处

beiwei5du

fyi