Data and informatics

Data integrity and electronic records

Data integrity includes the original record, metadata and context. FDA links audit-trail review to record review and risk, while retaining frequencies specified in applicable requirements.

Sources and scope checked: 3 October 2026 · Guide version 1

Scope: Review extends beyond a PDF copy or a signature alone.

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Prepare your evidence before a decision

Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.

Trace data creation, changes, retention and retrieval.
Review user permissions and privileged accounts.
Review audit trails alongside the relevant records.
Document retention and tested data retrieval.

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Data integrity and electronic records

Prepare your evidence before a decision

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