Laboratories are examined closely because their data supports release decisions, stability conclusions and submission content. The controls that matter are unglamorous and continuous.
Start with the data flow, not the system list
Map how a result travels from instrument to reported value, including every transcription, spreadsheet, printout and manual calculation along the way. The vulnerable points are usually where data leaves a controlled system and re-enters it.
Audit trail review must be scoped to be sustainable
A commitment to review all audit trails for all runs is common and rarely honored. A risk-based review — defined events, defined frequency, defined reviewer — is defensible and can actually be performed.
Access control is a data integrity control
- Unique credentials for every analyst, with no shared accounts
- Administrative privileges separated from analytical roles
- Documented review of user access at a defined interval
- Configuration settings locked and change-controlled
- Deletion and reprocessing rights restricted and recorded
Culture determines whether controls hold
If reporting an aberrant result reliably creates a difficult week for the analyst, the system is producing pressure in the wrong direction. Sustainable data integrity depends on investigation practices that treat unexpected data as information rather than as failure.