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Thus, a firm can possess modern instrumentation and still fail CGMP if it cannot demonstrate: (i) attributable actions (unique users), (ii) tamper-evident records (audit trails that cannot be disabled and are meaningfully reviewed), (iii) record permanence (prevent/controls over deletion plus validated backups), and (iv) verified correctness of input/output and calculations (including spreadsheet validation and retention)

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Researchers hope the findings will encourage further investigation into real-world experiences

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They are not identifiable patients or guarantees of coverage

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