FDA uses the term backup in § 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention period (e.g., § 211.180). Backup data must be exact, complete, and secure from alteration, inadvertent erasures, or loss (§ 211.68(b)). 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.

FDA使用§ 211.68(b)中的术语“备份”用来指在整个记录保存期间安全地保存的原始数据的真实有效副本（例如，§211.180）。备份文件应包含数据（包括相关元数据），并应以原始格式或与原始格式兼容的格式保存。

FDA’s use of the term backup is consistent with the term archive as used in guidance for industry and FDA staff General Principles of Software Validation.

FDA在行业指南和软件验证一般原则草案中对 "备份" 一词与 "归档" 一词的使用是一致的。

Temporary backup copies (e.g., in case of a computer crash or other interruption) would not satisfy the requirement in § 211.68(b) to maintain a backup file of data.

临时备份副本 (例如, 在计算机崩溃或其他中断的情况下) 不符合§ 211.68(b) 中保存数据备份文件的要求。