Lab
System suitability tests (HPLC/GC)
TL;DR
System Suitability Tests (SST) per USP <621> are the daily run-time checks — resolution, tailing, theoretical plates, RSD of replicate injections, signal-to-noise — that confirm the chromatographic system is fit before sample results are accepted. SST is the gate between the i...
System Suitability Tests (SST) per USP <621> are the daily run-time checks — resolution, tailing, theoretical plates, RSD of replicate injections, signal-to-noise — that confirm the chromatographic system is fit before sample results are accepted. SST is the gate between the instrument and the OOS investigation; without it a 'failure' cannot be defended as a real result and the data is unusable for release.
Regulatory anchors
- USP <621>
- ICH Q2(R2)
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
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