12 minAs seen by enrolled learners

In this lesson you will

Define data integrity in one sentence that covers a logbook page and a chromatography data system equally
Explain why an inspector spends the first hour with logbooks and audit trails, and what they are looking for
Apply the attributable, contemporaneous and original test to any entry and say which attribute is missing

Ask a room of GMP people what data integrity is and most of the answers will be about computers: audit trails, Annex 11, validated systems, passwords. Those things matter and the course gets to them in Module 3. But the definition regulators use is older and simpler than any of that. Data integrity is the degree to which data are complete, consistent and accurate throughout their life. It is a property of the record, and a record is a record whether it is a wet-ink batch page, a balance printout or a row in a LIMS.

What the definition asks of every entry

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Data integrity is a property of the record, not of the computer

In this lesson you will