5 Although we withdrew the draft steering on time stamps, our present thinking has not modified in that when using time stamps for systems that span different time zones, we don’t count on you to document the signer’s local time. When utilizing time stamps, they should be implemented with a clear understanding of the time zone reference used. In such cases, system documentation should clarify time zone references in addition to zone acronyms or other naming conventions. Records submitted to FDA, beneath predicate guidelines in electronic format (assuming the information have been recognized in docket number 92S-0251 as the forms of submissions the Agency accepts in electronic format). However, a report that isn’t itself submitted, but is utilized in generating a submission, is not a part 11 document until it is in any other case required to be maintained under a predicate rule and it is maintained in electronic format. We will enforce all predicate rule requirements, together with predicate rule document and recordkeeping requirements.
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