Hold-time studies determine how long an in-process material, bulk drug product, or cleaned-but-not-yet-used piece of equipment can be held before microbial, chemical, or physical attributes degrade. Approved hold times become operational limits enforced in the MMR/BMR.

V5 enforces hold times at the work-order step: the kiosk blocks restart once the validated window expires and routes the deviation automatically.

Regulatory anchors

EU GMP Annex 15
ICH Q7

Industries that live with this

Pharmaceutical Vet Pharma Blood & Tissue Food Processing

How V5 handles it

eBMR / eDHR — the batch record writes itself.

When the master is locked and the operator works on the kiosk, the batch record is no longer something to assemble — it’s something to render.

Related terms

Cleaning validation PPQ Deviation CPV