Audit Trail Shows a Backdated Entry
Select an audit-trail response that preserves original data, investigates intent and impact, and controls affected records.
DATA INTEGRITY DECISION A critical laboratory record changed after initial entry. The original and revised values may affect batch disposition. What should QA do first? Preserve the audit trail, place affected disposition on hold, document the anomaly, and assess impact with the lab and QA. Strong. This protects original metadata, avoids premature judgment, and keeps the release decision from outrunning the data-integrity assessment. Accept the analyst's explanation because corrections are normal in electronic systems. Weak. Corrections can be valid, but a changed critical time needs a documented reason and impact check. Trust without evidence violates the ALCOA+ principle. Terminate the…
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