Chapter 09 · the living feed
Notes · Bioanalytical.
The chronological feed of writing relevant to bioanalytical practice. Method validation under ICH M10, FDA 483 patterns, AI-augmented chromatography, the audit-trail problem when models touch peaks. Filtered from the global archive.
View global notes archive →2026-03-20
Bioanalytical method validation meets AI-augmented analysis.
What ICH M10 says about AI-touched chromatographic data. The audit-trail problem when a peak-integration model assists the analyst.
bioanalyticalICH M10AI augmentation
~7 min
2026-03-06
The 2025 483 pattern for bioanalytical: ISR, reagent-lot, partial validation.
iFeed's analysis of public 2025 FDA bioanalytical 483s and Warning Letters. Why ISR sample-selection randomisation showed up in ~28% of observed cases and what to do about it before the next inspection cycle.
bioanalyticalinspectionFDA 483
~8 min