V5 Ultimate
Compliance

Sanitation (21 CFR 111.15)

TL;DR

21 CFR 111.15 governs the physical plant and grounds — pest control, drainage, lighting, ventilation, water supply, plumbing, sewage, washing facilities, refuse, sanitary operations and the written sanitation procedures and master sanitation schedule. The MSS lists every clean...

21 CFR 111.15 governs the physical plant and grounds — pest control, drainage, lighting, ventilation, water supply, plumbing, sewage, washing facilities, refuse, sanitary operations and the written sanitation procedures and master sanitation schedule. The MSS lists every cleanable surface, the frequency, the responsible role and the verification method — and is one of the documents an FDA investigator asks for in the first 30 minutes.

Regulatory anchors
  • 21 CFR 111.15
How V5 handles it
QMS — quality engineered into every action, not bolted on.
Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Related terms
Personnel hygiene (21 CFR 111.10)
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