Unreviewed audit trails, shared analyst logins, and sample or injection sequences that were repeated without a recorded reason. In most cases the underlying cause is a laboratory under schedule pressure with system configuration that permits shortcuts.
Audit trail review is the first thing checked
If audit trail review is not a defined step in second-person data review, with evidence that it occurred, the laboratory cannot demonstrate that unreported results do not exist. That single gap tends to expand the scope of any review dramatically.
Configuration invites the finding
- Analysts holding permissions to delete or modify acquired data
- Shared or generic accounts on chromatography and balance systems
- Local acquisition with manual transfer to a network location
- Clocks not synchronized across instruments
- Trial injections or system suitability repeats without documented rationale
Culture is part of the control
Analysts who believe a repeat test will be treated as a personal failure will avoid recording one. A laboratory that treats an aberrant result as data — investigated on its merits — gets better records and better science at the same time.
Reviewed by the named consultant. Last updated July 14, 2026. General information only — not regulatory or legal advice for a specific situation.