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That is, the Agency may take your business practices into account in determining whether part 11 applies. Records submitted to FDA, under predicate rules in electronic format (assuming the records have been identified in docket number 92S-0251 as the types of submissions the Agency accepts in electronic format). However, a record that is not itself submitted, but is used in generating a submission, is not a part 11 record unless it is otherwise required to be maintained under a predicate rule and it is maintained in electronic format. Additionally, tens-of-thousands of items are accessible online through The Strong’s online database. Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. As long as predicate rule requirements are fully satisfied and the content and meaning of the records are preserved and archived, you