Data integrity Backup:
"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 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’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.
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."
--https://www.fda.gov/media/119267/download page 5
The key difference appears to be the accuracy, integrity, exact nature of the data, consistent with the meaning of archived, and PERMANENT. As opposed to temporary backup files kept for a period of time for reference and then overwritten, which don't meet the FDA definition of "backup" in the sense of data integrity.
-- jel@jelincoln.com
Remember, any electronic files retained as "backup", or for any other CGMP compliance reason, must be readable througout the lifetime of the record. This means that as technology changes electronic storage media, we must either keep obsolete readers in operating condition, or migrate our archived electronic records (and readers) over to the new media / readers, in harmony with CGMP requirements for the accuracy and verifiability / validatability of such a migration. - JEL 02/06/2023
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