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.
