Been noticing a pattern across a few pharma audits lately, seems like inspectors are no longer satisfied with a qualified still, signed SOPs, and twice-a-shift manual readings for WFI loops. Multiple facilities I've heard about were passing on paper but still got flagged the moment an inspector asked for a minute-by-minute trend at a specific user point.

From what I've dug into, USFDA and WHO-GMP auditors seem to be pushing hard for continuous, electronically recorded data now, specifically temperature, conductivity, TOC, and pure steam cycle data. There are also some pretty specific thresholds coming up in these audits, like hot loop temps needing to stay above 65°C and conductivity limits under USP <645>.

Wrote up a longer breakdown of what's actually triggering these findings and how 21 CFR Part 11 compliant electronic recording (versus manual logs) closes the gap before an inspector catches it, if anyone's dealing with a similar audit prep situation: [Why Pharma WFI Loops Lose Audit Points in 2026](https://www.gtek-india.com/wfi-loop-audit-gap-pharma-2026/)

Curious if others in QA/validation roles are seeing the same shift in audit expectations this year, or if it's more facility-specific.

Anyone else seeing more WFI/pure steam audit findings this year? (2026 GMP inspections)