Laboratory Safety, Instrumentation, and Data Integrity
Laboratory Safety, Instrumentation, and Data Integrity
This domain tests safe operation and trustworthy records: chemical hazards, engineering controls, gas and electrical safety, instrument qualification, and ALCOA+ data governance.
Core rules
- Use the safety data sheet for hazard, incompatibility and PPE information. Store acids and bases separately, oxidizers away from organics, and flammable solvents in approved cabinets.
- Work with volatile or toxic chemicals in a fume hood with verified airflow. Select gloves compatible with the specific chemical rather than relying on universal gloves.
- Secure compressed gas cylinders upright, cap them when not in use, and fit the correct regulator. Never use oil on oxygen fittings.
- Instrument qualification includes IQ/OQ/PQ, calibration, maintenance and performance checks. Keep records linked to the instrument and method.
- Data integrity follows ALCOA+: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available. Audit trails must be enabled, reviewable and not disableable by users. Manual integration needs a documented reason.
- Electronic records under 21 CFR Part 11 require access control, audit trails and secure backups.
Worked example
An audit trail shows a chromatogram reintegrated 2 hours after acquisition, changing the assay from 99.2% to 97.8%, with no reason recorded and the audit trail temporarily disabled. This is not a conservative result; it is a critical data-integrity failure because the record is not attributable or contemporaneous. Investigate the run, recover the original data, and do not release the result until the integration is justified and the audit trail is restored.
Traps
- Disabling audit trails to speed up processing.
- Using expired standards without documenting qualification.
- Storing raw data only in a personal folder.
- Assuming a fume hood protects at any sash height.
- Treating a software peak override as a routine correction.