US FDA
21 CFR 211.194 - Laboratory Records
Plain-language explanation, inspection context and common violation patterns.
What it says
Complete records of all laboratory testing must be maintained, including a description of the sample, the method used, and results, with data establishing that analytical methods used are accurate, sensitive, specific and reproducible, validated under actual conditions of use.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
What it means in practice
- This is the specific provision requiring documented analytical method validation data, distinct from the general laboratory controls requirement under 211.160.
- Laboratory records must be complete enough to allow full reconstruction of what was tested, how, and by whom, not just a final reported result.
- Validation under actual conditions of use means validation data specific to the site, equipment and analysts actually performing the testing, not simply inherited from a method's original development.
What FDA inspectors look for
- Whether raw laboratory data, not just summarised final results, is retained and reviewable, including electronic audit trails for computerised analytical instruments.
- Whether analytical method validation data specifically supports the method's use at the testing site, rather than being assumed valid because it worked elsewhere.
- Whether laboratory notebooks and electronic records show contemporaneous documentation consistent with ALCOA+ principles.
Most common violation
Analytical raw data, particularly electronic instrument data and audit trails, that is not fully retained or reviewed, making it impossible to reconstruct exactly what occurred during a specific test run.
Want a deeper, interactive breakdown?
GMPify's Regulation Explainer tool gives subscribers an AI-powered analysis of any 21 CFR, EU GMP, USP or ICH reference, with live inspection context.
Try the Regulation Explainer →