Purified Water (PW) for dietary supplement use is qualified against USP monograph limits of Total Organic Carbon ≤500 ppb (USP <643>) and conductivity ≤1.3 µS/cm at 25°C (USP <645>, three-stage test), plus microbial limits (typically ≤100 CFU/mL action level). The PW loop must be sanitisable, dead-leg <6×D, and continuously recirculated; an unmonitored softener+RO+UV is not USP PW unless the spec is qualified.

Regulatory anchors

USP <643>
USP <645>
USP <1231>

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.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.