Electronic
Persons must still comply with all applicable predicate rule requirements related to documentation of, for example, date (e.g., § 58.130), time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries. Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format. On the other hand, records that are not required to be retained under predicate rules, but that are nonetheless maintained in electronic format, are not part 11 records. FDA does not intend to object if you decide to archive required records in electronic format to nonelectronic media such as microfilm, microfiche, and paper, or to a standard electronic file format . Persons must still comply with all predicate rule requirements, and the records themselves and any copies of the required records should preserve their content and meaning. English Language Learners Definition O