Records which might be required to be maintained beneath predicate guidelines, which are maintained in electronic format in addition to paper format, and which are relied on to carry out regulated activities. We recommend that you simply decide, primarily based on the predicate rules, whether or not specific information are part 11 data. We expect continued compliance with these provisions, and we will continue to implement them. Furthermore, individuals should adjust to relevant predicate guidelines, and records which might be required to be maintained or submitted should remain secure and dependable in accordance with the predicate guidelines. We will implement all predicate rule necessities, together with predicate rule document and recordkeeping necessities.
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